A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Sponsor: GlaxoSmithKline

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
1 
 
Clinical Study Protocol 
Primary Study 
Intervention 
GSK’s investigational respiratory syncytial virus 
(RSV) vaccine BIO RSV OA=ADJ (GSK3844766A) 
Study Identifier 
219900 (RSV OA=ADJ-023) 
EU CT Number 
2023-503951-81-00 
Approval Date 
11 Oct 2023 
Title 
A Phase 2b, randomized, controlled, open-label study 
to evaluate the immune response and safety of the 
RSVPreF3 OA investigational vaccine in adults (≥18 
years of age) when administered to lung and renal 
transplant recipients comparing 1 versus 2 doses and 
compared to healthy controls (≥50 years of age) 
receiving 1 dose 
Brief Title 
A study on the immune response and safety of an RSV 
vaccine when given to adults 18 years of age and above 
who received lung or kidney transplant and are at an 
increased risk of respiratory syncytial virus lower 
respiratory tract disease and compared to healthy adults 
50 years of age and above 
Sponsor 
GlaxoSmithKline Biologicals S.A. 
Rue De L'Institut 89 
1330 Rixensart 
Belgium 
Sponsor signatory 
Veronica Hulstrøm, MD, PhD 
Clinical Project Lead 
RSV Older Adults 
Qualified Person for 
Pharmacovigilance/Delegate 
, MD, MBA 
 
 
Medical monitor name and contact can be found in local study contact 
information document 
©2023 GSK group of companies or its licensor. 
PPD
PPD

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
2 
PROTOCOL AMENDMENT 2 INVESTIGATOR AGREEMENT 
I agree: 
• 
To conduct the study in compliance with this protocol, any future protocol 
amendments, with the terms of the clinical trial agreement and with any other study 
conduct procedures and/or study conduct documents provided by GSK. 
• 
To assume responsibility for the proper conduct of the study at this site. 
• 
That I am aware of and will comply with GCP and all applicable regulatory 
requirements. 
• 
That I will comply with the terms of the site agreement. 
• 
To comply with local bio-safety legislation. 
• 
To ensure that all persons assisting me with the study are adequately informed about 
the GSK study intervention and other study-related duties and functions as described 
in the protocol. 
• 
To supervise any individual or party to whom I have delegated study-related duties 
and functions conducted at the study site. 
• 
To ensure that any individual or party to whom I have delegated study-related duties 
and functions conducted at the study site are qualified to perform those study-related 
duties and functions. 
• 
To acquire the reference ranges for laboratory tests performed locally and, if required 
by local regulations, obtain the laboratory’s current certification or Quality 
Assurance procedure manual. 
• 
To ensure that no clinical samples (including serum samples) are retained on-site or 
elsewhere without the approval of GSK and the express physical informed consent of 
the participant and/or the participant’s LAR. 
• 
To perform no biological assays on the clinical samples other than those described in 
the protocol or its amendment(s). 
• 
To co-operate with representative(s) of GSK in the monitoring and data management 
processes of the study with respect to data entry and resolution of queries about the 
data. 
• 
To have control of all essential documents and records generated under my 
responsibility before, during, and after the study. 
• 
That I have been informed that certain regulatory authorities require the sponsor to 
obtain and supply, as necessary, details about the investigator(s)’ ownership interest 
in the sponsor or the study intervention, and more generally about their financial ties 
with the sponsor. GSK will use and disclose the information solely for the purpose of 
complying with regulatory requirements. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
3 
Hence, I: 
• 
Agree to supply GSK with any necessary information regarding ownership interest 
and financial ties (including those of my spouse and dependent children). 
• 
Agree to promptly update this information if any relevant changes occur during the 
study and for 1 year following completion of the study. 
• 
Agree that GSK may disclose any information about such ownership interests and 
financial ties to regulatory authorities. 
• 
Agree to provide GSK with an updated Curriculum Vitae and all other documents 
required by regulatory agencies for this study. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
4 
Study identifier 
219900 (RSV OA=ADJ-023) 
EU CT number 
2023-503951-81-00 
Approval date 
11 Oct 2023 
Title 
A Phase 2b, randomized, controlled, open-label study 
to evaluate the immune response and safety of the 
RSVPreF3 OA investigational vaccine in adults (≥18 
years of age) when administered to lung and renal 
transplant recipients comparing 1 versus 2 doses and 
compared to healthy controls (≥50 years of age) 
receiving 1 dose 
Investigator name 
 
 
 
Signature 
 
Date of signature 
(DD Month YYYY) 
 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
5 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
DOCUMENT HISTORY 
Document 
Date of Issue 
Amendment 2 
11 Oct 2023 
Amendment 1 GER, ITA, SPN-1 
04 September 2023 
Original Protocol 
25 April 2023 
 
Type of Protocol 
Amendment 
Numbering 
Type of Changes 
Global 
Amendment 2 Final 
New changes to allow the 
inclusion of lung or renal 
transplant patients as of 18 YoA 
and above 
Country-specific 
Amendment 1 GER, ITA, 
SPN-1 Final 
New changes to address health 
authority feedback 
Amendment 2 (11 Oct 2023) 
This amendment is considered substantial based on the criteria defined in EU Clinical 
Trial Regulation No 536/2014 of the European Parliament and the Council of the 
European Union because it significantly impacts the scientific value of the study. 
Overall rationale for the current Amendment: 
To allow the inclusion of renal and lung solid organ transplant patients as of 18 years of 
age (YoA) and above. Renal and lung transplant recipient patients 18 YoA and above are 
at high risk of RSV-related LRTD, due to the life-long immunosuppressive therapy 
received for allograft rejection prevention regardless of their age [Dropulic, 2016; 
Fishman, 1998; Reichenberger, 2001]. 
Because of the safety signal of preterm birth observed in the RSV MAT-009 study, the 
initial RSV OA=ADJ-023 study protocol allowed only for the inclusion of participants as 
of 50 YoA (refer to Section 2.3.1). 
Further evaluation of the preterm birth signal based on different analyses of the RSV 
MAT-009 study data, research on plausible biological mechanisms and recommendations 
by external experts led to the following conclusions: 
• 
There is an identified risk for preterm birth in pregnant women vaccinated during the 
late second and third trimester with the RSV MAT vaccine candidate (refer to 
Section 2.3.1) and therefore pregnant women should be excluded from participation 
in the current study. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
6 
• 
The biological mechanism behind the identified risk of preterm birth in pregnant 
women who received the RSV MAT vaccine candidate is not known. Nevertheless, 
there is no theoretical mechanism to suggest a risk to future pregnancy for women 
vaccinated prior to pregnancy. 
• 
Precautionary measures to mitigate the risk of exposure to the RSVPreF3 OA 
vaccine at any time during pregnancy, such as not enrolling pregnant individuals, 
pregnancy testing before each administration of the study vaccine and adequate 
contraception for at least 1 month before the study intervention administration until 
the study end are included in the inclusion criteria in this study. (Refer to 
Section 10.4.1 for definitions of women of childbearing potential, menopause and 
Section 10.4.2 on adequate contraception). 
Given the high observed efficacy of the RSVPreF3 OA vaccine in clinical studies in 
individuals 60 YoA and older, and taking into account the precautionary measures to be 
implemented for this study and the unmet medical need in the renal and lung solid organ 
transplant patient population as of 18 YoA, the anticipated benefit-risk of the RSVPreF3 
OA vaccine supports the continued clinical development in less than 50-year-old non-
pregnant adults at increased risk, especially the immunocompromised (IC) population. 
Since the burden of RSV-related LRTD in healthy adults 18-49 YoA is low, the age 
range for the RSV_HA group was not adjusted. 
List of main changes in the protocol and their rationale: 
Section # and title 
Description of change 
Brief rationale 
Title page 
1.1 Synopsis 
1.2 Schema, Figure 1 
2.1 Study rationale 
4 Study design 
5.1 Inclusion Criteria 
6.3.2 Randomization to 
study intervention 
9.5 Pre-dose sample 
determination 
Inclusion of adults ≥18 YoA in 
the IC population (participants 
with lung or renal transplant). 
To include at risk population as 
of 18 YoA and improve the 
feasibilty of recruitment of IC 
population. 
2.1 Study rationale 
Added market approval 
information for RSV OA vaccine 
New information. 
2.2 Background 
Updated information on BoD of 
RSV in transplant patients. 
Correction. 
2.3 Benefit/risk 
assessment 
Updated risk information for 
study vaccine in adults < 60 
YoA. 
Consistency update for risk 
information in population <60 
YoA, as the age was lowered to 
include ≥18 YoA and above. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
7 
Section # and title 
Description of change 
Brief rationale 
Correction and clarifications 
provided for the mitigation 
strategy for potential risks. 
3 Objectives endpoints 
and estimands 
9.3.2 Secondary 
endpoints/estimands 
analyses 
Secondary immunogenicity 
endpoints and their estimands 
analyses were added. 
Added based on health 
authority feedback from Korea. 
Investigator agreement 
page, sections 5.1, 8.1.2, 
8.1.5, 8.2, 8.4.2, 8.4.8, 
10.1.3, 10.1.5, 10.3.3, 
10.3.4 and 10.3.5 
Inclusion of LAR in the study 
throughout relevant sections in 
the protocol. Information 
pertaining to informed assent for 
the minor added.  
Wording included for 
assent/consent of minor 
participants in certain countries 
where legal age for consent is 
≥18 YoA. 
6.9 Prior and concomitant 
therapy Table 10 
Updated the list of prohibited 
medication and washout period 
for SOT patients. 
Clarification. 
7.2. Participant 
discontinuation/withdrawal 
from the study 
Revised text related to sample 
handling and its documentation 
upon partcipant’s withdrawal 
from the study. 
Updated to allow sample 
handling as per local 
regulations, and in response to 
Health authority feedback. 
 
 
 
 
 
. 
Correction. 
8.4.1 Time period and 
frequency for collecting 
AE, SAE, and other safety 
information 
Removal of study intervention 
from collection of study 
participation related safety 
events. 
Correction. 
10.3.5 Recording, 
assessment and follow-up 
of AE, SAE, AESIs and 
pregnancies 
Table 24 
Update in description of intensity 
scales for solicited events. 
Clarification to site/investigator. 
10.4.2 Contraception 
guidance 
Table 26 
Footnote for recommendation for 
oral contraception added. 
Recommendation is suggested 
for population of ≥18 YoA as 
compared to ≥50 YoA earlier. 
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
8 
Section # and title 
Description of change 
Brief rationale 
10.6 Appendix 6: Country-
specific requirements 
10.6.3 South Korea 
Exclusion criteria updated. 
Country-specific age 
requirement for participants to 
be 19 years of age to be 
included in study. 
10.7 Appendix 7: Protocol 
amendment history 
Appendix created to capture the 
summary of prior amendments. 
Information for Amendment 1 
(amended based on European 
health authority feedback) 
moved to Appendix 7 and 
replaced with Amendment 2 
(current global amendment) 
information. 
Editorial changes to align with 
the Sponsor’s standard protocol 
template. 
Throughout 
Updated ‘RSV OA Vaccine’ to 
‘RSVPreF3 OA vaccine’. 
Consistency update in vaccine 
nomenclature across clinical 
and regulatory documents. 
List of abbreviations and 
definition of terms 
Updated the definition for 
Investigational product and 
defined concomitant 
medications, placebo, and 
standard of care. 
Updates to align with GSK 
standards for protocol template 
Throughout protocol 
Administrative and editorial 
changes were made to update 
sponsor signatory on cover 
page, align table numbers, 
formatting, and crossreferences. 
To maintain consistency with 
template guidance. 
 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
9 
TABLE OF CONTENTS 
PAGE 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ..................................... 5 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................ 16 
1. 
PROTOCOL SUMMARY ........................................................................................ 26 
1.1. 
Synopsis ..................................................................................................... 26 
1.2. 
Schema ...................................................................................................... 27 
1.3. 
Schedule of Activities (SoA) ........................................................................ 28 
2. 
INTRODUCTION .................................................................................................... 39 
2.1. 
Study rationale ............................................................................................ 39 
2.2. 
Background ................................................................................................ 40 
2.3. 
Benefit/risk assessment .............................................................................. 41 
2.3.1. 
Risk assessment .......................................................................... 41 
2.3.2. 
Benefit assessment ..................................................................... 43 
2.3.3. 
Overall benefit-risk conclusion ..................................................... 43 
3. 
OBJECTIVES, ENDPOINTS AND ESTIMANDS .................................................... 44 
4. 
STUDY DESIGN .................................................................................................... 45 
4.1. 
Overall design ............................................................................................. 45 
4.2. 
Scientific rationale for study design ............................................................. 46 
4.2.1. 
Participant input into design ......................................................... 47 
4.3. 
Justification for dose ................................................................................... 47 
4.4. 
End of study definition................................................................................. 47 
5. 
STUDY POPULATION ........................................................................................... 48 
5.1. 
Inclusion criteria .......................................................................................... 48 
5.1.1. 
Inclusion criteria for all participants .............................................. 48 
5.1.2. 
Specific inclusion criteria for renal/lung transplant patients .......... 49 
5.1.3. 
Specific inclusion criteria for renal transplant (RTx) 
patients ........................................................................................ 49 
5.1.4. 
Specific inclusion criteria for lung transplant (LTx) patients .......... 49 
5.1.5. 
Specific inclusion criteria for healthy participants ......................... 49 
5.2. 
Exclusion criteria ......................................................................................... 50 
5.2.1. 
Medical conditions ....................................................................... 50 
5.2.2. 
Prior/Concomitant therapy ........................................................... 51 
5.2.3. 
Prior/Concurrent clinical study experience ................................... 51 
5.2.4. 
Other exclusion criteria ................................................................ 51 
5.2.4.1. 
Specific exclusion criteria for renal/lung 
transplant patients: ..................................................... 52 
5.2.4.2. 
Specific exclusion criteria for RTx patients: ................ 53 
5.2.4.3. 
Specific exclusion criteria for LTx patients: ................. 53 
5.2.4.4. 
Specific exclusion criteria for healthy 
participants: ................................................................ 53 
5.3. 
Lifestyle considerations ............................................................................... 53 
5.4. 
Screen failures ............................................................................................ 54 
5.5. 
Criteria for temporarily delaying enrollment/ administration of study 
intervention ................................................................................................. 54 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
10 
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY .................................. 55 
6.1. 
Study intervention administered .................................................................. 55 
6.1.1. 
Medical devices ........................................................................... 55 
6.2. 
Preparation, handling, storage, and accountability ...................................... 56 
6.3. 
Assignment to study intervention ................................................................ 56 
6.3.1. 
Participant identification ............................................................... 56 
6.3.2. 
Randomization to study intervention ............................................ 56 
6.3.3. 
Intervention allocation to the participant ....................................... 57 
6.3.4. 
Allocation of participants to CMI assay subsets ........................... 57 
6.4. 
Blinding ....................................................................................................... 58 
6.5. 
Study intervention compliance .................................................................... 58 
6.6. 
Dose modification ....................................................................................... 58 
6.7. 
Continued access to study intervention after the end of the study ............... 58 
6.8. 
Treatment of overdose ................................................................................ 58 
6.9. 
Prior and concomitant therapy .................................................................... 58 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................... 60 
7.1. 
Discontinuation of study intervention ........................................................... 60 
7.1.1. 
Contraindications to subsequent study intervention 
administration .............................................................................. 61 
7.2. 
Participant discontinuation/withdrawal from the study ................................. 62 
7.3. 
Lost to follow-up.......................................................................................... 63 
8. 
STUDY ASSESSMENTS AND PROCEDURES ..................................................... 63 
8.1. 
Administrative and baseline procedures ..................................................... 65 
8.1.1. 
Collection of demographic data .................................................... 65 
8.1.2. 
Medical/vaccination history .......................................................... 65 
8.1.3. 
Record specific participant transplant information ........................ 66 
8.1.4. 
Record height and weight ............................................................ 66 
8.1.5. 
Targeted physical examination/history-directed physical 
examination ................................................................................. 67 
8.1.6. 
Vital signs .................................................................................... 67 
8.1.7. 
Allograft rejection ......................................................................... 68 
8.1.7.1. 
Record estimated glomerular filtration rate 
(eGFR) and proteinuria/albuminuria (only in 
RTx patients) .............................................................. 68 
8.1.7.2. 
Record bronchoscopy and/or transbronchial 
lung biopsy (TBBx) (only in LTx patients) ................... 69 
8.1.7.3. 
Record FEV1 (only in LTx patients) ............................ 69 
8.1.7.4. 
Imaging results (RTx and LTx patients) ...................... 69 
8.1.7.5. 
Biopsy results (RTx and LTx patients) ........................ 70 
8.2. 
Immunogenicity assessments ..................................................................... 70 
8.2.1. 
Biological samples ....................................................................... 70 
8.2.2. 
Laboratory assays ....................................................................... 71 
8.2.3. 
Immunological read-outs .............................................................. 72 
8.2.4. 
Cytology ...................................................................................... 73 
8.2.5. 
Immunological correlates of protection ......................................... 73 
8.3. 
Safety assessments .................................................................................... 73 
8.3.1. 
Clinical safety laboratory tests ..................................................... 73 
8.3.3. 
Pregnancy testing ........................................................................ 74 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
11 
8.3.4. 
Safety monitoring and Committee ................................................ 74 
8.4. 
Adverse events (AEs), serious adverse events (SAEs), and other 
safety reporting ........................................................................................... 74 
8.4.1. 
Time period and frequency for collecting AE, SAE, and 
other safety information ............................................................... 75 
8.4.2. 
Method of detecting AEs and SAEs ............................................. 78 
8.4.3. 
Follow-up of AEs and SAEs ......................................................... 78 
8.4.4. 
AESIs .......................................................................................... 78 
8.4.4.1. 
Potential immune-mediated diseases ......................... 78 
8.4.4.2. 
Atrial fibrillation (AF) ................................................... 83 
8.4.4.3. 
AESI for Transplant patients ....................................... 84 
8.4.5. 
Regulatory reporting requirements for 
SAEs/pregnancies/AESIs ............................................................ 84 
8.4.6. 
Pregnancy ................................................................................... 85 
8.4.7. 
Contact information for reporting SAEs, AESIs and 
pregnancies ................................................................................. 86 
8.4.8. 
Participant card ............................................................................ 86 
8.5. 
Pharmacokinetics ....................................................................................... 86 
8.6. 
Pharmacodynamics .................................................................................... 86 
8.7. 
Genetics ..................................................................................................... 86 
8.8. 
Biomarkers ................................................................................................. 86 
8.9. 
Immunogenicity assessments ..................................................................... 86 
8.10. 
Health economics or medical resource utilization and health 
economics .................................................................................................. 86 
9. 
STATISTICAL CONSIDERATIONS ........................................................................ 87 
9.1. 
Statistical Hypotheses................................................................................. 87 
9.2. 
Analysis sets ............................................................................................... 87 
9.2.1. 
Criteria for elimination from analysis ............................................ 87 
9.3. 
Statistical analyses ..................................................................................... 88 
9.3.1. 
Primary endpoints/estimands analyses ........................................ 88 
9.3.2. 
Secondary endpoints/estimands analyses ................................... 88 
9.4. 
Interim analysis ........................................................................................... 90 
9.4.1. 
Sequence of analyses.................................................................. 90 
9.4.2. 
Statistical considerations for interim analysis ............................... 90 
9.5. 
Pre-dose sample size determination ........................................................... 90 
9.5.1. 
Sample size justification ............................................................... 91 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................... 92 
10.1. 
Appendix 1: Regulatory, ethical, and study oversight considerations .......... 92 
10.1.1. 
Regulatory and ethical considerations ......................................... 92 
10.1.2. 
Financial disclosure ..................................................................... 93 
10.1.3. 
Informed consent process ............................................................ 93 
10.1.4. 
Recruitment strategy .................................................................... 94 
10.1.5. 
Data protection ............................................................................ 94 
10.1.6. 
Committees structure ................................................................... 95 
10.1.7. 
Dissemination of Clinical Study Data ........................................... 95 
10.1.8. 
Data quality assurance ................................................................ 96 
10.1.9. 
Source documents ....................................................................... 97 
10.1.10. Study and site start and closure ................................................... 97 
10.1.11. Publication policy ......................................................................... 98 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
12 
10.2. 
Appendix 2: Clinical laboratory tests ........................................................... 98 
10.2.1. 
RSV-A and RSV-B neutralization assays ..................................... 98 
10.2.2. 
Intracellular cytokine staining ....................................................... 99 
10.3. 
Appendix 3: AEs and SAEs: Definitions and procedures for 
recording, evaluating, follow-up, and reporting .......................................... 100 
10.3.1. 
Definition of AE .......................................................................... 100 
10.3.2. 
Definition of SAE ........................................................................ 101 
10.3.3. 
Solicited events.......................................................................... 102 
10.3.4. 
Unsolicited AE ........................................................................... 103 
10.3.5. 
Recording, assessment and follow-up of AE, SAE, AESIs 
and pregnancies ........................................................................ 103 
10.3.5.1. AE and SAE recording .............................................. 103 
10.3.5.2. Assessment of intensity ............................................ 104 
10.3.5.3. Assessment of causality ........................................... 106 
10.3.5.4. Assessment of outcomes.......................................... 107 
10.3.5.5. Follow-up of AEs, SAEs, AESIs and 
pregnancies .............................................................. 107 
10.3.5.6. Updating of SAE, AESI and pregnancy 
information after removal of write access to the 
participant’s eCRF .................................................... 108 
10.3.5.7. Reporting of SAEs, AESIs and pregnancies ............. 108 
10.4. 
Appendix 4: Guidance on Contraception, Women not considered as 
WOCBP and collection of pregnancy information ...................................... 109 
10.4.1. 
Definitions .................................................................................. 109 
10.4.1.1. Woman of childbearing potential (WOCBP) .............. 109 
10.4.1.2. Woman of Nonchildbearing potential 
(WONCBP) ............................................................... 109 
10.4.2. 
Contraception guidance ............................................................. 110 
10.4.2.1. Woman of childbearing potential (WOCBP) .............. 110 
10.5. 
Appendix 5: Grading scales in scope of the SOT population ..................... 111 
10.5.1. 
Chronic kidney disease (CKD) classification in RTx 
patients ...................................................................................... 111 
10.5.1.1. Revised equations for eGFR from serum 
creatinine in Japan ................................................... 111 
10.5.2. 
Proteinuria/albuminuria categories in CKD in RTx patients ........ 112 
10.5.3. 
Staging of bronchoscopy – acute cellular rejection (ACR) 
in LTx patients ........................................................................... 113 
10.5.4. 
Grading of bronchoscopy – antibody-mediated rejection 
(AMR) in LTx patients ................................................................ 113 
10.5.5. 
CLAD staging in LTx patients ..................................................... 113 
10.6. 
Appendix 6: Country-specific requirements ............................................... 113 
10.6.1. 
Germany .................................................................................... 113 
10.6.2. 
Japan ......................................................................................... 116 
10.6.3. 
South Korea ............................................................................... 117 
10.7. 
Appendix 7: Protocol amendment history .................................................. 117 
11. REFERENCES ..................................................................................................... 121 
 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
13 
LIST OF TABLES 
PAGE 
Table 1 
Schedule of Activities for the IC 1-dose group (RSV_IC_1) .................... 28 
Table 2 
Schedule of Activities for the IC 2-dose group (RSV_IC_2) .................... 32 
Table 3 
Schedule of Activities for the healthy participants group 
(RSV_HA) .............................................................................................. 36 
Table 4 
Intervals between study visits for IC 1-dose group (RSV_IC_1) ............. 39 
Table 5 
Intervals between study visits for IC 2-dose group (RSV_IC_2) ............. 39 
Table 6 
Intervals between study visits for healthy participant group 
(RSV_HA) .............................................................................................. 39 
Table 7 
Objectives, endpoints and estimands ..................................................... 44 
Table 8 
Study Intervention Administered ............................................................. 55 
Table 9 
Allocation to CMI subset ......................................................................... 57 
Table 10 
Prohibited medications and washout period ........................................... 59 
Table 11 
Timing of collection of concomitant medication to be recorded ............... 60 
Table 12 
Biological samples .................................................................................. 70 
Table 13 
Laboratory assays .................................................................................. 71 
Table 14 
Immunological read-outs ........................................................................ 72 
Table 15 
Timeframes for collecting and reporting of safety information in 
IC 1-dose group and healthy participant group ....................................... 76 
Table 16 
Timeframes for collecting and reporting of safety information in 
IC 2-dose group ..................................................................................... 77 
Table 17 
List of potential immune-mediated diseases (pIMDs) ............................. 79 
Table 18 
Timeframes for submitting SAEs, pregnancies and AESIs to GSK ......... 85 
Table 19 
Contact information for reporting SAEs, AESIs and pregnancies ........... 86 
Table 20 
Analysis sets .......................................................................................... 87 
Table 21 
Estimate of the fold-increase that can be detected by power .................. 91 
Table 22 
Solicited administration site events....................................................... 102 
Table 23 
Solicited systemic events ..................................................................... 102 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
14 
Table 24 
Intensity scales for solicited events in participants ≥18 YoA (IC 
group) and ≥50 YoA (HA group) ........................................................... 105 
Table 25 
Intensity scales of administration site redness/swelling, and fever ....... 105 
Table 26 
Highly effective contraceptive methods ................................................ 110 
Table 27 
Proteinuria/albuminuria categories in CKD ........................................... 112 
Table 28 
Relationship among categories for albuminuria and proteinuria ........... 112 
Table 29 
Classification of ACR ........................................................................... 113 
Table 30 
Classification of AMR ........................................................................... 113 
Table 31 
Stages of CLAD ................................................................................... 113 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
15 
LIST OF FIGURES 
PAGE 
Figure 1 
Study design overview ........................................................................... 27 
 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
16 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
List of Abbreviations 
Abbreviation 
Definition 
ACR 
Acute cellular rejection 
AE 
Adverse event 
AESI 
Adverse event of special interest 
AF 
Atrial fibrillation 
ALT 
Alanine aminotransferase 
AMR 
Antibody-mediated rejection 
ANCOVA 
Analysis of covariance 
AST 
Aspartate aminotransferase 
BAL 
Bronchoalveolar lavage 
BoD 
Burden of disease 
CCI 
Commercially confidential information 
CD 
Cluster of differentiation  
CI 
Confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CKD 
Chronic kidney disease 
CLAD 
Chronic lung allograft dysfunction 
CLS 
Clinical laboratory sciences 
CMI 
Cell-mediated immunity 
CMV 
Cytomegalovirus 
CONSORT 
Consolidated Standards of Reporting Trials 
COPD 
Chronic obstructive pulmonary disease 
COVID-19 
Coronavirus disease 2019 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
17 
Abbreviation 
Definition 
CRA 
Clinical research associate 
CRO 
Contract research organization 
CSR 
Clinical study report 
DFP 
Direct-from-participant 
DRC 
Data review committee 
DTP 
Direct-to-participant 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form  
ED 
Early discontinuation 
eGFR 
Estimated glomerular filtration rate 
EMA 
European Medicines Agency 
EoS 
End of study 
ES 
Exposed set 
EU 
European Union 
EUA 
Emergency use authorization 
FAS 
Full analysis set 
FEV1 
Forced expiratory volume in 1 second 
FSFV 
First subject first visit 
FSH 
Follicle stimulating hormone 
FVC 
Forced vital capacity 
GCP 
Good clinical practices 
GFR 
Glomerular filtration rate 
GMT 
Geometric mean titer 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
18 
Abbreviation 
Definition 
GSK 
GlaxoSmithKline Biologicals S.A. 
HHS 
Home healthcare services 
HI 
Humoral immunity 
HLT 
High Level Term 
HRT 
Hormonal replacement therapy 
IAF 
Informed assent form 
IB 
Investigator’s brochure 
IC 
Immunocompromised 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
ICS 
Intracellular cytokine staining 
IDMC 
Independent data monitoring committee 
IEC 
Independent ethics committee 
IFN 
Interferon 
IgA 
Immunoglobulin A 
IL 
Interleukin 
IM 
Intramuscular 
IMP 
Investigational medicinal product 
IRB 
Institutional review board 
ISHLT 
International Society for Heart and Lung Transplantation  
IUD 
Intrauterine device 
IUS 
Intrauterine hormone-releasing system 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
19 
Abbreviation 
Definition 
LAR 
Legally acceptable representative 
LRTD 
Lower respiratory tract disease 
LSLV 
Last Subject Last Visit 
LTx 
Lung translplant 
MDRD 
Modification of Diet in Renal Disease 
MedDRA 
Medical Dictionary for Regulatory Activities 
MGI 
Mean geometric increase 
OA 
Older adults 
PBMC 
Peripheral blood mononuclear cells 
PD 
Pharmacodynamic 
pDiary 
Paper diary  
pIMD 
Potential immune-mediated disease 
PK 
Pharmacokinetic 
PPS 
Per protocol set 
PRB 
Protocol review board 
PT 
Preferred term 
PTB 
Preterm birth 
QS-21: 
Quillaja saponaria Molina, fraction 21 (Licensed by GSK from 
Antigenics LLC, a wholly owned subsidiary of Agenus Inc., a 
Delaware, USA corporation) 
QTL 
Quality tolerance limit 
RNA 
Ribonucleic acid 
rSDV 
Remote source data verification 
RSV 
Respiratory Syncitial Virus 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
20 
Abbreviation 
Definition 
RSV-LRTD 
RSV-lower respiratory tract disease 
RTI 
Respiratory tract infections 
RTSM 
Randomization and Trial Supply Management 
RTx 
Renal transplant 
RZV 
Recombinant Zoster vaccine 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAR 
Serious adverse reaction 
SDV 
Source data verification 
SmPC 
Summary of product characteristics 
SoA 
Schedule of activities 
SoC 
Standard of care 
SOC 
System organ class 
SOT 
Solid organ transplant 
SRT 
Safety Review Team 
SUSAR 
Suspected unexpected serious adverse reaction 
TLC 
Total lung capacity 
TNF 
Tumor necrosis factor 
TOC 
Table of contents 
Tx 
Transplant 
UK 
United Kingdom 
US/USA 
United States of America 
WBC 
White blood cell 
WOCBP 
Woman of childbearing potential 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
21 
Abbreviation 
Definition 
WONCBP 
Woman of nonchildbearing potential 
YoA 
Years of age 
Definition of Terms 
Term 
Definition 
Adverse event 
Any untoward medical occurrence in a patient or clinical 
investigation participant, temporally associated with the use of a 
medicinal product, whether or not considered related to the 
medicinal product. 
An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease 
(new or exacerbated) temporally associated with the use of a 
medicinal product. For marketed medicinal products, this also 
includes failure to produce expected benefits (i.e., lack of 
efficacy), abuse or misuse. 
Adverse event of 
special interest 
An adverse event of special interest (serious or non-serious) is one 
of scientific and medical concern specific to the sponsor’s product 
or program, for which ongoing monitoring and rapid 
communication by the investigator to the sponsor can be 
appropriate. Such an event might warrant further investigation in 
order to characterize and understand it. Depending on the nature 
of the event, rapid communication by the trial sponsor to other 
parties (e.g., regulators) might also be warranted. 
Blinding 
A procedure in which 1 or more parties to the study are kept 
unaware of the intervention assignment in order to reduce the risk 
of biased study outcomes. The level of blinding is maintained 
throughout the conduct of the study, and only when the data are 
cleaned to an acceptable level of quality will appropriate 
personnel be unblinded or when required in case of a SAE. 
In an open-label study, no blind is used. Both the investigator and 
the participant know the identity of the intervention assigned. 
Caregiver 
A ‘caregiver’ is someone who 
• 
lives in the close surroundings of a participant and has a 
continuous caring role or 
• 
has substantial periods of contact with a participant and is 
engaged in their daily health care (e.g., a relative of the 
participant, a nurse who helps with daily activities in case of 
residence in a nursing home). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
22 
Term 
Definition 
In the context of a clinical study, a caregiver could include an 
individual appointed to oversee and support the participant's 
compliance with protocol-specified procedures(such as 
transcribing responses to diaries, receiving phone calls, planning 
study visits, etc.). However, at no time, the caregiver should 
evaluate the participant’s health status while answering diaries or 
make decisions on behalf of the participant. 
Certified copy 
A copy (irrespective of the type of media used) of the original 
record that has been verified (i.e., by a dated signature or by 
generation through a validated process) to have the same 
information, including data that describe the context, content, and 
structure, as the original. 
Co-administered 
(concomitant) 
products 
A product given to clinical trial participants as required in the 
protocol as part of their standard care for a condition which is not 
the indication for which the IMP is being tested and is therefore 
not part of the objective of the study. 
Direct-from-
Participant 
Shipments 
Home pickup of collected biological specimens, or pickup and 
return of unused/partially used/expired trial materials for return to 
investigator site. 
Direct-to-
Participant 
Shipments 
Shipping of lab kits, devices, etc., to the participant’s residence 
under secure and controlled conditions. 
Eligible 
Qualified for enrollment into the study based upon strict 
adherence to inclusion/exclusion criteria. 
Enrolled 
participant 
All participants who entered the study (who were randomized or 
received study intervention administration or underwent a post-
screening study procedure). 
NOTE: screening failures (who never passed screening even if 
rescreened) and participants screened (met eligibility) but never 
enrolled into the study are excluded from the Enrolled Set as they 
did not enter the study. 
Refer to the Section 9.2 for the definition of ‘Enrolled Set’ 
applicable to the study. 
Essential 
documents 
Documents which individually and collectively permit evaluation 
of the conduct of a study and the quality of the data produced. 
Evaluable 
Meeting all eligibility criteria, complying with the procedures 
defined in the protocol, and, therefore, included in the per protocol 
analysis. 
Home Healthcare 
Services  
Deployment of mobile health care professional(s) (nurses or 
phlebotomists) to perform study activities remotely. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
23 
Term 
Definition 
Intercurrent 
medical condition 
A condition that has the capability of altering the immune 
response to the study vaccine or is confirmed to have an alteration 
of the participant’s initial immune status. 
Intervention 
number 
A number identifying an intervention to a participant, according to 
intervention allocation. 
Invasive medical 
device 
A device which, in whole or in part, penetrates inside the body, 
either through a body orifice or through the surface of the body. 
Investigational 
product 
A pharmaceutical form of an active substance or placebo being 
tested or used as a reference in a clinical trial, including products 
already with a marketing authorization but used or assembled 
(formulated or packaged) in a way different from the authorised 
form, or when used for an unauthorised indication, or when used 
to gain further information about the authorised form. 
Investigator 
A person responsible for the conduct of the clinical study at a 
study site. If a study is conducted by a team of individuals at a 
study site, the investigator is the responsible leader of the team 
and may be called the principal investigator. 
The investigator can delegate study-related duties and functions 
conducted at the study site to qualified individual or party to 
perform those study-related duties and functions. 
Participant 
Term used throughout the protocol to denote an individual who 
has been contacted to participate or who participates in the clinical 
study as a recipient of the study intervention 
(vaccine(s)/product(s)/control). 
Synonym: subject. 
Participant 
number 
A unique identification number assigned to each participant who 
consents to participate in the study. 
Placebo 
An inactive substance or treatment that looks the same as, and is 
given in the same way as, an active drug or intervention/treatment 
being studied. 
Primary 
Completion Date 
The date on which the last participant in a clinical study was 
examined or received an intervention to collect final data for 
the primary outcome measure. 
Whether the clinical study ended according to the protocol or was 
terminated does not affect this date. For clinical studies with more 
than one primary outcome measure with different completion 
dates, this term refers to the date on which data collection is 
completed for all the primary outcome measures.  

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
24 
Term 
Definition 
Protocol 
amendment 
The ICH defines a protocol amendment as: ‘A written description 
of a change(s) to or formal clarification of a protocol.’ GSK 
further details this to include a change to an approved protocol 
that affects the safety of participants, scope of the investigation, 
study design, or scientific integrity of the study. 
Randomization 
Process of random attribution of intervention to participants to 
reduce selection bias. 
Screened 
participant 
All participants who were screened for eligibility. 
Self-contained 
study 
Study with objectives not linked to the data of another study. 
Serious Adverse 
Reaction 
 
All noxious and unintended responses to an IMP related to any 
dose administered that result in death, are life-threatening, require 
patient hospitalization or prolongation of existing hospitalization, 
result in persistent or significant disability or incapacity, or are a 
congenital anomaly or birth defect. 
Solicited event 
Events to be recorded as endpoints in the clinical study. The 
presence/occurrence/intensity of these events is actively solicited 
from the participant or an observer during a specified follow-up 
period following study intervention administration. 
Source data 
All information in original records and certified copies of original 
records of clinical findings, observations, or other activities in a 
clinical study necessary for the reconstruction and evaluation of 
the study. Source data are contained in source documents (original 
records or certified copies). 
Source documents Original legible documents, data, and records (e.g., hospital 
records, clinical and office charts, laboratory notes, memoranda, 
participants' diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate copies, 
microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, participant files, and records kept at the pharmacy, 
laboratories and at medico-technical departments involved in the 
clinical study). 
Standard of Care 
Medicine(s) for a specific indication, or a component of the 
standard care for a particular medical indication, based on national 
and/or international consensus; there is no regulatory significance 
to this term. 
Products/regimens considered standard of care may differ country 
to country, depending on consensus in individual countries. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
25 
Term 
Definition 
Study completion 
date 
The date on which the last participant in a clinical study was 
examined or received an intervention/treatment to collect final 
data for the primary outcome measures, secondary outcome 
measures, and AEs (that is, the last participant's last visit or 
LSLV). 
Study intervention Term used throughout the clinical study to denote a set of 
investigational product(s) or marketed product(s) or placebo 
intended to be administered to a participant. 
Study monitor 
An individual assigned by the sponsor and responsible for 
assuring proper conduct of clinical studies at 1 or more 
investigational sites. 
Sub-cohort 
A group of participants for whom specific study procedures are 
planned as compared to other participants or a group of 
participants who share a common characteristic (e.g., ages, 
vaccination schedule, etc.) at the time of enrollment. 
Synonym: subset. 
Suspected 
Unexpected 
Serious Adverse 
Reaction 
A Suspected Unexpected Serious Adverse Reaction is a Serious 
Adverse Reaction whose nature, severity or outcome is not 
consistent with the reference safety information. 
Unsolicited 
adverse event 
Any AE reported in addition to those solicited during the clinical 
study. Also, any ‘solicited’ symptom with onset outside the 
specified period of follow-up for solicited symptoms will be 
reported as an unsolicited adverse event. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
26 
1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol Title: A Phase 2b, randomized, controlled, open-label study to evaluate the 
immune response and safety of the RSVPreF3 OA investigational vaccine in adults 
(≥18 years of age) when administered to lung and renal transplant recipients comparing 1 
versus 2 doses and compared to healthy controls (≥50 years of age) receiving 1 dose. 
Brief Title: A study on the immune response and safety of an RSV vaccine when given 
to adults 18 years of age and above who received a lung or kidney transplant and are at an 
increased risk of respiratory syncytial virus lower respiratory tract disease and compared 
to healthy adults 50 years of age and above. 
Rationale: Refer to Section 2.1. 
Objectives, Endpoints, and Estimands: Refer to Section 3. 
Overall Design: Refer to Sections 1.2 and 4.1. 
Number of Participants: Refer to Section 9.5. 
Data Monitoring/Other Committee: Refer to Section 10.1.6. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
27 
1.2. 
Schema 
Figure 1 
Study design overview 
 
*Screening Visit: Only in IC population. Blood sample would be collected at screening visit to evaluate participant eligibility. 
**Visit 2: Only in a subset of the study population, ~30% of the participants (Visit can occur 7-14 days after first study intervention administration). 
^ Solicited and unsolicited AEs after second study intervention administration, only in the IC 2-dose group. 
AE = Adverse event; AESI = Adverse event of special interest; CMI = Cell-mediated immunity; EoS = End of study; HI = Humoral immunity; IC = Immunocompromised; 
pIMD = Potential immune-mediated disease; SAE = Serious adverse event; YoA = Years of age. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
28 
1.3. 
Schedule of Activities (SoA) 
Table 1 
Schedule of Activities for the IC 1-dose group (RSV_IC_1) 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Baseline and demography assessments 
Informed consent 
● 
 
 
 
 
 
 
See Section 10.1.3 for details 
Assignment/recording of participant 
number 
● 
 
 
 
 
 
 
See Section 6.3.1 for details 
Check inclusion and exclusion criteria 
● 
● 
 
 
 
 
 
See Sections 5.1 and 5.2 for 
details 
Check with participants if he/she will 
appoint a caregiver, and distribute 
caregiver information letter to caregiver, 
when applicable 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8 for details 
Collect demographic data 
● 
 
 
 
 
 
 
See Section 8.1.1 for details 
Record relevant medical history 
● 
 
 
 
 
 
 
See Section 8.1.2 for details 
Record vaccination history 
● 
 
 
 
 
 
 
See Section 8.1.2 for details 
Record specific transplant information 
● 
 
 
 
 
 
 
See Section 8.1.3 for details 
Record height and weight 
● 
 
 
 
 
 
 
See Section 8.1.4 for details 
History directed physical examination 
 ○ 
 
 
 
 
 
 
See Section 8.1.5 for details 
Record vital signs 
 
●b 
 
 
 
 
 
See Section 8.1.6 for details 
Screening conclusion 
● 
 
 
 
 
 
 
 
Laboratory assessments 
Safety blood sample (Hematology & 
Biochemistry for liver and renal function; 
 ~ 6 mL) 
● 
 
 
 
 
 
 
See Section 8.3.1 for details 
Urine pregnancy test (if applicable, 
WOCBP only) 
● 
●b 
 
 
 
 
 
See Section 8.3.3 for details 
Blood sampling (~ 8.5 mL) for RSV 
neutralizing titers 
 
●b 
● 
● 
● 
● 
● 
See Section 8.2 for details 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
29 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Blood sampling (~ 30 mL) for CMI 
response (in CMI subset only) 
 
●b 
● 
● 
● 
● 
● 
See Section 8.2 for details 
Study intervention administration 
Distribution of ‘Participant card’ 
 
○ 
 
 
 
 
 
See Section 8.4.8 for details 
Check contraindications, warnings, and 
precautions to vaccination 
 
○ 
 
 
 
 
 
See Section 7.1.1 for details 
Check criteria for temporary delay for 
enrollment and study intervention 
administration 
 
○ 
 
 
 
 
 
See Section 5.5 for details 
Body temperature before study 
intervention administration 
 
● 
 
 
 
 
 
The location for measuring 
temperature will be oral or 
axillary (See Section 8.1.6). 
Fever is defined as 
temperature 
≥38.0°C/100.4°F, regardless 
of the location of 
measurement. 
Randomization, study group and 
intervention number allocation 
 
 ○ 
 
 
 
 
 
See Section 6.3 for details 
Study intervention administration 
(including 30-minutes post-study 
intervention administration observation) 
 
● 
 
 
 
 
 
See Section 6.1 for details 
Recording of administered study 
intervention number 
 
● 
 
 
 
 
 
See Section 6.3.3 for details 
Safety assessments 
Provide post-vaccination diary cards 
 
 ○ 
 
 
 
 
 
See Section 10.3.5.1 for 
details 
Train participants on completion of diary 
cards 
 
 ○ 
 
 
 
 
 
See Section 10.3.5.1 for 
details 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
30 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Return of post-vaccination diary cards 
 
 
○c 
 ○ 
 
 
 
See Section 10.3.5.1 for 
details 
Verify and transcribe post-vaccination 
diary cards 
 
 
 
● 
 
 
 
See Section 10.3.5.1 for 
details 
Record SoC results of eGFR and 
proteinuria/albuminuria in RTx patients d 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.1 for details 
Record SoC results of bronchoscopy 
and/or TBBx in LTx patients, if available 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.2 for details 
Record SoC results of FEV1 in LTx 
patients, if available e 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.3 for details 
Record SoC results of imaging in RTx 
and LTx patients, if available 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.4 for details 
Targeted physical exam (as needed, 
SoC) 
 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8.1.5 for details 
Record concomitant 
medication/vaccination 
● 
● 
● 
● 
● 
● 
● 
See Section 6.9 for details 
Record solicited administration site and 
systemic events (within 7 days post-study 
intervention administration) 
 
● 
● 
● 
 
 
 
See Section 10.3.5 for details 
Record unsolicited AEs (within 30 days 
post-study intervention administration) f 
 
● 
● 
● 
 
 
 
See Section 10.3.5 for details 
Record SAEs related to study 
participation or concurrent GSK 
medication/vaccine 
● 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
31 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Record: 
- All SAEs f 
- All pIMDs 
- Pregnancies 
- AESIs specific for renal/lung transplant 
- (S)AEs leading to withdrawal from the 
study 
- Intercurrent medical conditions 
 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 
Study conclusion 
 
 
 
 
 
 
● 
See Section 4.4 for details 
Note: The double-line borders indicate the analyses which will be performed on all data (i.e., data that are as clean as possible) obtained up to these timepoints. 
AE = Adverse event; AESI = Adverse event of specific interest; AF = Atrial fibrillation; CMI = Cell-mediated immunity; eCRF = electronic case report form; eGFR = estimated glomerular 
filtration rate; FEV1 = forced expiratory volume in 1 second; LTx = Lung transplant; 
; pIMDs = Potential immune-mediated diseases; RSV 
= Respiratory Syncytial Virus; RTx = Renal transplant; SAE = Serious adverse event; SoC = Standard of care; TBBx = Transbronchial Bioscopy; WOCBP = Women of 
childbearing potential. 
● is used to indicate a study procedure that requires documentation in the individual eCRF. 
○ is used to indicate a study procedure that does not require documentation in the individual eCRF. 
a Visit 2 is planned in the CMI subset of the study population (30% of the group population i.e., 38 participants in the group, at the designated CMI sites). 
b Vital signs, urine sample for pregnancy test and blood sampling for RSV neutralizing titers, CMI and 
 must be taken on the same day, prior to study intervention 
administration. If the study intervention administration is delayed by any reason, the vital signs and samples (both blood and urine) will need to be collected again on the day of 
study intervention administration, urine pregnancy test needs to be repeated, and the first blood sample will be destroyed. 
c Participants must bring their diary cards at this visit for review and the same would be re-dispensed to them. 
d eGFR measurements are performed in RTx patients at the central lab at screening visit. At subsequent visits, it is recorded if performed as SoC. Proteinuria/albuminuria is recorded, if 
performed as SoC in RTx patients. 
e FEV1 results recorded only at health facility (hospital, clinic, site) will be used. 
f AF will be considered as AESI in this study and will be additionally reported in the AF follow-up questionnaire (electronic or paper) in eCRF. The collection of AF will be performed 
following the AE/SAE reporting periods. The reporting of non-serious AF will be performed according to the unsolicited AE reporting period. The reporting of AF meeting the SAE 
definition (serious AF) will be performed according to the SAE reporting period. 
Under special circumstances, home visits may be conducted at the discretion of the investigator (Refer to Section 8 for details). 
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
32 
Table 2 
Schedule of Activities for the IC 2-dose group (RSV_IC_2) 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 3 + 180-
210 days 
Visit 3 + 350-
380 days 
 
Baseline and demography assessments 
Informed consent 
● 
 
 
 
 
 
 
See Section 10.1.3 for details 
Assignment/recording of participant 
number 
● 
 
 
 
 
 
 
See Section 6.3.1 for details 
Check inclusion and exclusion criteria 
● 
● 
 
 
 
 
 
See Sections 5.1 and 5.2 for 
details 
Check with participants if he/she will 
appoint a caregiver, and distribute 
caregiver information letter to caregiver, 
when applicable 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8 for details 
Collect demographic data 
● 
 
 
 
 
 
 
See Section 8.1.1 for details 
Record relevant medical history 
● 
 
 
 
 
 
 
See Section 8.1.2 for details 
Record vaccination history 
● 
 
 
 
 
 
 
See Section 8.1.2 for details 
Record specific transplant information 
● 
 
 
 
 
 
 
See Section 8.1.3 for details 
Record height and weight 
● 
 
 
 
 
 
 
See Section 8.1.4 for details 
History directed physical examination 
 ○ 
 
 
 
 
 
 
See Section 8.1.5 for details 
Record vital signs 
 
●b 
 
●b 
 
 
 
See Section 8.1.6 for details 
Screening conclusion 
● 
 
 
 
 
 
 
 
Laboratory assessments 
Safety blood sample (Hematology & 
Biochemistry for liver and renal function; 
~6 mL) 
● 
 
 
 
 
 
 
See Section 8.3.1 for details 
Urine pregnancy test (if applicable, 
WOCBP only) 
● 
●b 
 
●b 
 
 
 
See Section 8.3.3 for details 
Blood sampling (~ 8.5 mL) for RSV 
neutralizing titers 
 
●b 
● 
●b 
● 
● 
● 
See Section 8.2 for details 
Blood sampling (~ 30 mL) for CMI 
response (in CMI subset only) 
 
●b 
● 
●b 
● 
● 
● 
See Section 8.2 for details 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
33 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 3 + 180-
210 days 
Visit 3 + 350-
380 days 
 
Study intervention administration 
Distribution of ‘Participant card’ 
 
 ○ 
 
 
 
 
 
See Section 8.4.8 for details 
Check contraindications, warnings, and 
precautions to vaccination 
 
 ○ 
 
 ○ 
 
 
 
See Section 7.1.1 for details 
Check criteria for temporary delay for 
enrollment 
 
 ○ 
 
 
 
 
 
See Section 5.5 for details 
Check criteria for temporary delay of 
study intervention administration 
 
 ○ 
 
 ○ 
 
 
 
See Section 5.5 for details 
Body temperature before study 
intervention administration 
 
● 
 
● 
 
 
 
The location for measuring 
temperature will be oral or 
axillary (See Section 8.1.6). 
Fever is defined as 
temperature 
≥38.0°C/100.4°F, regardless 
of the location of 
measurement. 
Randomization, study group allocation 
 
 ○ 
 
 
 
 
 
See Section 6.3 for details 
Intervention number allocation 
 
 ○ 
 
 ○ 
 
 
 
See Section 6.3 for details 
Study intervention administration 
(including 30-minutes post-study 
intervention administration observation) 
 
● 
 
● 
 
 
 
See Section 6.1 for details 
Recording of administered study 
intervention number 
 
● 
 
● 
 
 
 
See Section 6.3.3 for details 
Safety assessments 
Provide post-vaccination diary cards 
 
 ○ 
 
 ○ 
 
 
 
See Section 10.3.5.1 for 
details 
Train participants on completion of diary 
cards 
 
 ○ 
 
 
 
 
 
See Section 10.3.5.1 for 
details 
Return of post-vaccination diary cards 
 
 
 ○c 
 ○ 
 ○ 
 
 
See Section 10.3.5.1 for 
details 
Verify and transcribe post-vaccination 
diary cards 
 
 
 
● 
● 
 
 
See Section 10.3.5.1 for 
details 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
34 
Type of contact 
Screening 
Visit 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
-30 to -7 
days 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 3 + 180-
210 days 
Visit 3 + 350-
380 days 
 
Record SoC results of eGFR and 
proteinuria/albuminuria in RTx patients d 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.1 for details 
Record SoC results of bronchoscopy 
and/or TBBx in LTx patients, if available 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.2 for details 
Record SoC results of FEV1 in LTx 
patients, if available e 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.3 for details 
Record SoC results of imaging in RTx 
and LTx patients, if available 
● 
● 
● 
● 
● 
● 
● 
See Section 8.1.7.4 for details 
Targeted physical exam (as needed, 
SoC) 
 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8.1.5 for details 
Record concomitant 
medication/vaccination 
● 
● 
● 
● 
● 
● 
● 
See Section 6.9 for details 
Record solicited administration site and 
systemic events (within 7 days post-study 
intervention administration) 
 
● 
● 
● 
● 
 
 
See Section 10.3.5 for details 
Record unsolicited AEs (within 30 days 
post-study intervention administration) f 
 
● 
● 
● 
● 
 
 
See Section 10.3.5 for details 
Record SAEs related to study 
participation or concurrent GSK 
medication/vaccine 
● 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 
Record: 
- All SAEs f 
- All pIMDs 
- Pregnancies 
- AESIs specific for renal/lung transplant 
- (S)AEs leading to withdrawal from the 
study 
- Intercurrent medical conditions 
 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 
Study conclusion 
 
 
 
 
 
 
● 
See Section 4.4 for details 
Note: The double-line borders indicate the analyses which will be performed on all data (i.e., data that are as clean as possible) obtained up to these timepoints. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
35 
AE = Adverse event; AESI = Adverse event of specific interest; AF = Atrial fibrillation; CMI = Cell-mediated immunity; eCRF = electronic case report form; eGFR = estimated glomerular 
filtration rate; FEV1 = forced expiratory volume in 1 second; LTx = Lung transplant; 
; pIMDs = Potential immune-mediated diseases; RSV 
= Respiratory Syncytial Virus; RTx = Renal transplant; SAE = Serious adverse event; SoC = Standard of care; TBBx = Transbronchial Bioscopy; WOCBP = Women of 
childbearing potential. 
● is used to indicate a study procedure that requires documentation in the individual eCRF. 
○ is used to indicate a study procedure that does not require documentation in the individual eCRF. 
a Visit 2 is planned in the CMI subset of the study population (30% of the group population i.e., 38 participants in the group, at the designated CMI sites). 
b Vital signs, urine sample for pregnancy test and blood sampling for RSV neutralizing titers, CMI and 
 must be taken on the same day, prior to study intervention 
administration. If the study intervention administration is delayed by any reason, the vital signs and samples (both blood and urine) will need to be collected again on the day of 
study intervention administration, urine pregnancy test needs to be repeated, and the first blood sample will be destroyed. 
c Participants must bring their diary cards at this visit for review, and the same would be re-dispensed to them. 
d eGFR measurements are performed in RTx patients at the central lab at screening visit. At subsequent visits, it is recorded if performed as SoC. Proteinuria/albuminuria is recorded, if 
performed as SoC in RTx patients. 
e FEV1 results recorded only at health facility (hospital, clinic, site) will be used. 
f AF will be considered as AESI in this study and will be additionally reported in the AF follow-up questionnaire (electronic or paper) in eCRF. The collection of AF will be performed 
following the AE/SAE reporting periods. The reporting of non-serious AF will be performed according to the unsolicited AE reporting period. The reporting of AF meeting the SAE 
definition (serious AF) will be performed according to the SAE reporting period. 
Under special circumstances, home visits may be conducted at the discretion of the investigator (Refer to Section 8 for details). 
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
36 
Table 3 
Schedule of Activities for the healthy participants group (RSV_HA) 
Type of contact 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Baseline and demography assessments 
Informed consent 
● 
 
 
 
 
 
See Section 10.1.3 for details 
Assignment/recording of participant number 
● 
 
 
 
 
 
See Section 6.3.1 for details 
Check inclusion and exclusion criteria 
● 
 
 
 
 
 
See Sections 5.1 and 5.2 for 
details 
Check with participants if he/she will appoint a caregiver, 
and distribute caregiver information letter to caregiver, 
when applicable 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8 for details 
Collect demographic data 
● 
 
 
 
 
 
See Section 8.1.1 for details 
Record relevant medical history 
● 
 
 
 
 
 
See Section 8.1.2 for details 
Record vaccination history 
● 
 
 
 
 
 
See Section 8.1.2 for details 
Record height and weight 
● 
 
 
 
 
 
See Section 8.1.4 for details 
History directed physical examination 
 ○ 
 
 
 
 
 
See Section 8.1.5 for details 
Record vital signs 
 ●b 
 
 
 
 
 
See Section 8.1.6 for details 
Screening conclusion 
● 
 
 
 
 
 
 
Laboratory assessments 
Urine pregnancy test (if applicable, WOCBP only) 
●b 
 
 
 
 
 
See Section 8.3.3 for details 
Blood sampling (~ 8.5 mL) for RSV neutralizing titers 
●b 
● 
● 
● 
● 
● 
See Section 8.2 for details 
Blood sampling (~ 30 mL) for CMI response (in CMI 
subset only) 
●b 
● 
● 
● 
● 
● 
See Section 8.2 for details 
Study intervention administration 
Distribution of ‘Participant card’ 
○ 
 
 
 
 
 
See Section 8.4.8 for details 
Check contraindications, warnings, and precautions to 
vaccination 
○ 
 
 
 
 
 
See Section 7.1.1 for details 
Check criteria for temporary delay for enrollment and 
study intervention administration 
○ 
 
 
 
 
 
See Section 5.5 for details 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
37 
Type of contact 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Body temperature before study intervention 
administration 
● 
 
 
 
 
 
The location for measuring 
temperature will be oral or 
axillary (See Section 8.1.6). 
Fever is defined as 
temperature 
≥38.0°C/100.4°F, regardless 
of the location of 
measurement. 
Study group and intervention number allocation 
 ○ 
 
 
 
 
 
See Section 6.3 for details 
Study intervention administration (including 30-minutes 
post-study intervention administration observation) 
● 
 
 
 
 
 
See Section 6.1 for details 
Recording of administered study intervention number 
● 
 
 
 
 
 
See Section 6.3.3 for details 
Safety assessments 
Provide post-vaccination diary cards 
 ○ 
 
 
 
 
 
See Section 10.3.5.1 for 
details 
Train participants on completion of diary cards 
 ○ 
 
 
 
 
 
See Section 10.3.5.1 for 
details 
Return of post-vaccination diary cards 
 
 ○c 
 ○ 
 
 
 
See Section 10.3.5.1 for 
details 
Verify and transcribe post-vaccination diary cards 
 
 
● 
 
 
 
See Section 10.3.5.1 for 
details 
Targeted physical examination (as needed, SoC) 
 
 ○ 
 ○ 
 ○ 
 ○ 
 ○ 
See Section 8.1.5 for details 
Record concomitant medication/vaccination 
● 
● 
● 
● 
● 
● 
See Section 6.9 for details 
Record solicited administration site and systemic events 
(within 7 days post-study intervention administration) 
● 
● 
● 
 
 
 
See Section 10.3.5 for details 
Record unsolicited AEs (within 30 days post-study 
intervention administration) d 
● 
● 
● 
 
 
 
See Section 10.3.5 for details 
Record SAEs related to study participation or concurrent 
GSK medication/vaccine 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
38 
Type of contact 
Visit 1 
Visit 2a 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Notes 
Time points 
Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 days 
 
Record: 
- All SAEs d 
- All pIMDs 
- Pregnancies 
- (S)AEs leading to withdrawal from the study 
- Intercurrent medical conditions 
● 
● 
● 
● 
● 
● 
See Section 10.3.5 for details 
Study conclusion 
 
 
 
 
 
● 
See Section 4.4 for details 
Note: The double-line borders indicate the analyses which will be performed on all data (i.e., data that are as clean as possible) obtained up to these timepoints. 
AE = Adverse event; AESI = Adverse event of specific interest; AF = Atrial fibrillation; CMI = Cell-mediated immunity; eCRF = electronic case report form; pIMDs = Potential immune-
mediated diseases; RSV = Respiratory Syncytial Virus; SAE = Serious adverse event; SoC = Standard of care; WOCBP = Women of childbearing potential. 
● is used to indicate a study procedure that requires documentation in the individual eCRF. 
○ is used to indicate a study procedure that does not require documentation in the individual eCRF. 
a Visit 2 is planned in the CMI subset of the study population (30% of the group population i.e., 38 participants in the group, at the designated CMI sites). 
b Vital signs, urine sample for pregnancy test and blood sampling for RSV neutralizing titers, CMI and 
 must be taken on the same day, prior to study intervention 
administration. If the study intervention administration is delayed by any reason, the vital signs and samples (both blood and urine) will need to be collected again on the day of 
study intervention administration, urine pregnancy test needs to be repeated, and the first blood sample will be destroyed. 
c Participants must bring their diary cards at this visit for review, and the same would be re-dispensed to them. 
d AF will be considered as AESI in this study and will be additionally reported in the AF follow-up questionnaire (electronic or paper) in eCRF. The collection of AF will be performed 
following the AE/SAE reporting periods. The reporting of non-serious AF will be performed according to the unsolicited AE reporting period. The reporting of AF meeting the SAE 
definition (serious AF) will be performed according to the SAE reporting period. 
Under special circumstances, home visits may be conducted at the discretion of the investigator (Refer to Section 8 for details). 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
39 
Table 4 
Intervals between study visits for IC 1-dose group (RSV_IC_1) 
Interval 
Planned visit interval 
Allowed interval range 
Screening Visit → Visit 1 
-7 days 
-30 to -7 days 
Visit 1 → Visit 2* 
7 days 
7 - 14 days 
Visit 1 → Visit 3 
30 days 
30 - 60 days 
Visit 3 → Visit 4 
30 days 
30 - 42 days 
Visit 1 → Visit 5 
180 days 
180 - 210 days 
Visit 1 → Visit 6 
365 days 
350 - 380 days 
* Only in the CMI subset. 
Table 5 
Intervals between study visits for IC 2-dose group (RSV_IC_2) 
Interval 
Planned visit interval 
Allowed interval range 
Screening Visit → Visit 1 
-7 days 
-30 to -7 days 
Visit 1 → Visit 2* 
7 days 
7 - 14 days 
Visit 1 → Visit 3 
30 days 
30 - 60 days 
Visit 3 → Visit 4 
30 days 
30 - 42 days 
Visit 3 → Visit 5 
180 days 
180 - 210 days 
Visit 3 → Visit 6 
365 days 
350 - 380 days 
* Only in the CMI subset. 
Table 6 
Intervals between study visits for healthy participant group 
(RSV_HA) 
Interval 
Planned visit interval 
Allowed interval range 
Visit 1 → Visit 2* 
7 days 
7 - 14 days 
Visit 1 → Visit 3 
30 days 
30 - 60 days 
Visit 3 → Visit 4 
30 days 
30 - 42 days 
Visit 1 → Visit 5 
180 days 
180 - 210 days 
Visit 1 → Visit 6 
365 days 
350 - 380 days 
* Only in the CMI subset. 
2. 
INTRODUCTION 
2.1. 
Study rationale 
GSK has developed a RSVPreF3 OA vaccine against RSV-associated (subtypes A and B) 
disease in adults ≥60 YoA at an increased risk of RSV-LRTD. The vaccine was first 
approved for use in adults ≥60 YoA in the US on 03 May 2023, EU on 06 June 2023, UK 
on 07 July 2023, Canada on 04 Aug 2023, and Japan on 25 September 2023, under the 
tradename Arexvy. Additionally, immunocompromised patients such as SOT recipients, 
who are under chronic immunosuppressive therapy required to prevent organ rejection, 
are at high risk of severe RSV-LRTD. The aim of this open-label study is to evaluate the 
immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine 
in an immunocompromised (lung and renal transplant recipients, 18 YoA and above) 
population and assess whether a second dose of the vaccine increases the immune 
response. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
40 
2.2. 
Background 
RSV is an RNA virus of which 2 antigenically distinct subtypes exist, referred to as 
RSV-A and RSV-B [Borchers, 2013]. RSV causes RTI in people of all ages. In addition 
to the high BoD in children and older adults (≥60 YoA), RSV infection is an important 
cause of severe lower respiratory disease in the IC population [Pochon, 2019]. Currently, 
there are 2 vaccines available for prevention of RSV infection in adults ≥60 YoA; Arexvy 
(manufactured by GSK) and Abrysvo (manufactured by Pfizer Inc). 
GSK is developing the adjuvanted RSVPreF3 OA vaccine (Arexvy) for patient 
populations at increased risk of RSV-LRTD. 
Recent in-house results from a Phase 3 clinical trial in older adults (RSV OA=ADJ-004) 
demonstrated that one dose of the RSVPreF3 OA investigational vaccine-induced strong 
humoral and cell-mediated immune responses, which remained above pre-vaccination 
levels up to at least 13 months post-vaccination. In another large Phase 3 vaccine clinical 
trial (RSV OA=ADJ-006) in adults aged 60 years and above, the vaccine candidate 
demonstrated an overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1) against 
RSV-LRTD up to 6 months post-vaccination. The vaccine was well tolerated with an 
acceptable safety profile [Papi, 2023]. The study is still ongoing to assess other 
endpoints. However, all studies done until now included only non-IC participants. 
In general, IC patients are at increased risk of severe disease following an infection and 
tend to have lower immune responses following vaccination [Dropulic, 2016]. The IC 
population is a heterogenous group of patients which include patients with SOT, cancer 
patients (hematologic and solid organ tumors) on active treatment, patients on 
immunotherapy for autoimmune diseases, patients with congenital immuno-deficiencies, 
and patients living with HIV with low CD4 T-cell counts. Within the IC population, the 
SOT patients are under chronic immunosuppressive therapy required to prevent organ 
rejection, which places them at high risk of severe RSV-LRTD associated with a high 
morbidity and mortality [Dropulic, 2016; Fishman, 1998; Reichenberger, 2001]. 
The BoD of RSV infections is well-documented in lung transplant recipients, with 
mortality attributable to RSV-LRTD in this population reported from 10 to 20% 
[Neemann, 2015]. Although RSV burden in renal transplant recipients has been less 
thoroughly documented, those patients like other IC patients remain at increased risk for 
respiratory viral infections in general and RSV-LRTDs in particular, due to the IC status 
and immunosuppressive therapy. In general, IC patients exhibit lower immune responses 
following vaccination. Nevertheless, a recent clinical trial demonstrated that an 
adjuvanted RZV was immunogenic in chronically immunosuppressed renal transplant 
recipients ≥18 YoA [Vink, 2020]. 
Please refer to the IB for information regarding pre-clinical studies, and clinical studies of 
RSVPreF3 OA investigational vaccine. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
41 
2.3. 
Benefit/risk assessment 
2.3.1. 
Risk assessment 
Detailed information about the known and expected benefits, potential risks, and 
reasonably expected AEs of RSVPreF3 OA investigational vaccine can be found in the 
IB. 
Potential Risk 
of Clinical 
Significance 
Rationale for Risk 
Mitigation Strategy 
RSVPreF3 OA investigational vaccine 
pIMDs 
pIMDs are considered a potential risk for 
this vaccine. 
Refer to Section 8.4.4 for details. 
Hypersensitivity 
reactions 
(including 
anaphylaxis)  
Previous exposure to components of the 
vaccine might have induced an immune 
response that results in an exaggerated or 
inappropriate reaction. 
All participants will remain under observation at 
the clinical center for at least 30 minutes after 
study intervention administration or longer if 
deemed necessary by site personnel. 
Appropriate medical care must be readily 
available during this period. 
Participants with a history of hypersensitivity or 
severe allergic reaction to any component of the 
vaccine are excluded from study enrollment. 
Syncope 
(fainting)  
Syncope (fainting) can occur following or 
even before study intervention 
administration as a psychogenic response 
to the needle insertion. 
Participants who mention experiencing previous 
episodes of fainting or dizziness before, during 
or after vaccination, will be asked to lie down 
during the intervention and remain under 
observation at the clinical center for at least 30 
minutes after study intervention administration or 
longer if deemed necessary by site personnel. 
Appropriate medical care must be readily 
available during this period. 
Allograft 
rejection  
Allograft rejection is a theoretical concern 
with adjuvanted vaccines in solid organ 
transplant participants. To date, there is no 
evidence of an increased risk of allograft 
rejection as demonstrated in ZOSTER-041 
study [Vink, 2020], nor with other vaccines.  
During the informed consent process for 
vaccination, the participants will be informed of 
this potential risk and the need to inform the 
clinic/site and seek medical attention if unwell 
after vaccination. Clinical management of 
allograft rejection will be per local standard of 
care and recorded as AE/SAE, as appropriate. 
The occurrence of allograft rejection during the 
study will be described. 
Study procedures 
Local reactions 
at the injection 
site 
Intramuscular vaccination commonly 
precipitates a transient and self-limiting 
local inflammatory reaction. This may 
typically include pain at injection site, 
erythema/redness, and swelling. 
Physician can implement the measures that they 
consider necessary. 
Solicited local adverse events (AE) will be 
collected and reviewed up to Day 7 following 
vaccination. 
Local reactions 
at site of blood 
draw 
Pain, redness, irritation, and bruising may 
occur at the site where blood is drawn. 
Physician can implement the measures that they 
consider necessary. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
42 
Potential Risk 
of Clinical 
Significance 
Rationale for Risk 
Mitigation Strategy 
Syncope 
(fainting)  
Syncope (fainting) can occur following or 
even before any blood draw as a 
psychogenic response to the needle 
insertion. 
Participants who mention experiencing previous 
episodes of fainting or dizziness before, during 
or after a blood draw, will be asked to lie down 
during the intervention and remain under 
observation at the clinical center for at least 30 
minutes after blood draw or longer if deemed 
necessary by site personnel. 
Appropriate medical care must be readily 
available during this period. 
For details of study procedures, dose, and study design justification, refer to Section 1.3 
and Section 4.2. 
In parallel with the RSVPreF3 OA clinical development program, another RSV vaccine 
development program was initiated by GSK, with the objective to prevent RSV-
associated lower respiratory tract illness in neonates and infants during their first 
6 months of life, through immunization of pregnant women with a single dose of the 
investigational RSV maternal vaccine candidate. 
In 2020, GSK initiated a Phase 3, double-blind, 2:1-randomized, placebo-controlled study 
(RSV MAT-009; NCT04605159) in 24 countries to assess the safety and efficacy of the 
maternal vaccine candidate (RSVPreF3 Mat) administered to 18–49-year-old women in 
the late second or third trimester of pregnancy. 
In February 2022, GSK decided to stop enrollment and vaccination in RSV maternal 
vaccine studies involving pregnant women. This decision was taken because of an 
observed imbalance in the proportions of both preterm births and neonatal deaths (death 
of an infant within the first 28 days of life) in the treatment group vs. the placebo group 
in the RSV MAT-009 study. Subsequently, the enrollment and vaccination in all studies 
of the RSV maternal vaccine candidate involving women of childbearing potential were 
also stopped. 
Following the Day 43 post-birth interim analysis (DLP 04 October 2022) of the RSV 
MAT-009 study, GSK concluded that preterm birth is an identified risk for the pregnant 
women population, for the RSV maternal vaccine candidate. The observed numerical 
imbalance in neonatal deaths is not an independent safety signal but a consequence of the 
imbalance in preterm births. GSK has discontinued the further development of this RSV 
maternal vaccine candidate. 
The safety concern is specific to women who received the RSV maternal vaccine 
candidate during the late second or third trimester of pregnancy. To date, analyses of the 
available safety data have not established what caused the observed imbalance in preterm 
births. 
The vaccine candidate for older adults (RSV PreF3 OA vaccine), contains the same RSV 
antigen as the RSV maternal vaccine candidate but the RSVPreF3 OA vaccine is 
combined with GSK’s established AS01E adjuvant to boost the immune response in the 
OA population. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
43 
 
 
 
. As a 
precautionary measure, no pregnant women will be included and all WOCBP will be 
required to use adequate contraception and have a negative pregnancy test prior to each 
vaccination in this study. Study participants will be adequately informed of the risks 
associated with pregnancy as the informed consent contains specific information 
regarding the RSV Maternal study. 
The RSVPreF3 OA vaccine trials in participants ≥60 YoA are closely monitored for 
safety with all available safety data reviewed internally. In addition, the Phase 3 RSV 
OA=ADJ-006 clinical study is monitored by an IDMC on an ongoing basis. The IDMC 
has not raised any concern for safety in the OA population. The RSVPreF3 OA vaccine 
has not been studied in pregnant women to date. 
2.3.2. 
Benefit assessment 
The participants may or may not benefit directly from participating in this study. By 
receiving the RSVPreF3 OA vaccine, the participant may have the benefit of being 
protected against RSV-associated disease. In a prespecified efficacy interim analysis of 
an ongoing Phase 3 trial (RSV OA=ADJ-006) in participants ≥60 YoA, for those 
receiving a single dose of the RSVPreF3 OA investigational vaccine, the primary 
endpoint was met with a high vaccine efficacy during the first RSV season and no 
unexpected safety concerns were observed (refer to IB). 
However, patients under immune suppression often respond less well to vaccines, and 
therefore, the information obtained in this study, namely whether a second dose can 
increase the immune response in IC patients, will further aid the development of the 
RSVPreF3 OA vaccine. It will be the first time the vaccine will be administered in IC 
participants ≥18 YoA, who are generally at an increased risk of developing severe RSV-
LRTD. 
Another benefit for all study participants may include gaining information about their 
general health status through the medical evaluations/assessments associated with this 
study (i.e., extra physical examination). 
2.3.3. 
Overall benefit-risk conclusion 
The RSVPreF3 OA investigational vaccine is in clinical development. Considering the 
measures taken to minimize the risk to participants in this study, the potential risks are 
justified by the potential benefits linked to the development of this vaccine. 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
44 
3. 
OBJECTIVES, ENDPOINTS AND ESTIMANDS 
Table 7 
Objectives, endpoints and estimands 
Objectives 
Endpoints and estimands 
Primary 
• 
To evaluate the humoral immune 
response against RSV-A following the 
first and the second dose of RSVPreF3 
OA investigational vaccine within 2-dose 
group in renal and lung SOT patients. 
• 
RSV-A serum neutralizing titers expressed as MGI post-
Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and 
lung SOT patients in the 2-dose group. 
• 
To evaluate the humoral immune 
response against RSV-B following the 
first and the second dose of RSVPreF3 
OA investigational vaccine within 2-dose 
group in renal and lung SOT patients. 
• 
RSV-B serum neutralizing titers expressed as MGI post-
Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and 
lung SOT patients in the 2-dose group. 
Secondary-Immunogenicity 
• 
To evaluate the humoral immune 
response to the RSVPreF3 OA 
investigational vaccine until 12 months 
post-study intervention administration in 
all groups. 
• 
RSV-A and RSV-B serum neutralizing titers expressed as 
GMT, at pre-study intervention administration, Visit 2* (in a 
subset of participants), Visit 3*, Visit 4*, Visit 5* and Visit 6* 
in renal and lung SOT patients (1-dose and 2-dose group), 
and healthy participants. 
• 
RSV-A and RSV-B serum neutralizing titers expressed as 
group GMT ratio RSV_HA over RSV_IC (pooled 
RSV_IC_1 and RSV_IC_2 groups) at Visit 2* (in a subset 
of participants) and Visit 3* and RSV_IC_2 over 
RSV_IC_1, RSV_HA over RSV_IC_1, and RSV_HA over 
RSV_IC_2) at Visit 4*, Visit 5* and Visit 6*. 
• 
RSV-A and RSV-B serum neutralizing titers expressed as 
MGI at Visit 2* (in a subset of participants) over Visit 1, and 
Visit 3* over Visit 1* in RSV_HA and RSV_IC (pooled 
RSV_IC_1 and RSV_IC_2 groups) and at Visit 4*, Visit 5* 
and Visit 6* over Visit 1* in RSV_IC_1, RSV_2, RSV_HA 
groups. 
• 
To evaluate the CMI response following 
RSVPreF3 OA investigational vaccine 
administration in a subset of participants 
in all groups. 
• 
CMI response expressed as group geometric mean of the 
frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells 
expressing at least 2 activation markers including at least 
one cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL-
13, and IL-17 at pre-study intervention administration, Visit 
2*, Visit 3*, Visit 4*, Visit 5* and Visit 6*, in a subset of 
participants (renal and lung SOT patients (1-dose and 2-
dose group), and healthy participants). 
Secondary-Safety 
• 
To evaluate the safety and reactogenicity 
following RSVPreF3 OA investigational 
vaccine administration in all groups. 
• 
Percentage of participants reporting each solicited 
administration site event with onset within 7 days post-
study intervention administration (i.e., the day of 
vaccination and 6 subsequent days). 
• 
Percentage of participants reporting each solicited 
systemic event with onset within 7 days post-study 
intervention administration (i.e., the day of vaccination and 
6 subsequent days). 
• 
Percentage of participants reporting unsolicited AEs within 
30 days post-study intervention administration (i.e., the day 
of vaccination and 29 subsequent days). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
45 
Objectives 
Endpoints and estimands 
• 
Percentage of participants reporting SAEs after study 
intervention administration (Day 1) up to study end (Visit 
6). 
• 
Percentage of participants reporting pIMDs after study 
intervention administration (Day 1) up to study end (Visit 
6). 
• 
Percentage of participants reporting SAEs related to study 
intervention administration after study intervention 
administration (Day 1) up to study end (Visit 6). 
• 
Percentage of participants reporting pIMDs related to study 
intervention administration after study intervention 
administration (Day 1) up to study end (Visit 6). 
• 
Percentage of participants reporting fatal SAEs after study 
intervention administration (Day 1) up to study end (Visit 
6). 
• 
Percentage of participants reporting AESIs (specific to 
renal and lung SOT patients) after first study intervention 
administration (Day 1) up to study end (Visit 6). 
Tertiary 
(Note that the tertiary objective, endpoints, and estimands are optional and will only be assessed if needed; 
therefore, not all testing might be performed and reported) 
AE = Adverse event; AESI = Adverse event of special interest; CD = Cluster of differentiation; CMI = Cell-mediated 
immunity; 
; 
; IFN = Interferon; IL = Interleukin; 
GMT = Geometric mean titer; MGI = Mean geometric increase; 
; OA = 
Older adult; pIMD = Potential immune-mediated disease; RSV = Respiratory Syncytial Virus; SAE = Serious 
adverse event; SOT = Solid organ transplant; TNF = Tumor necrosis factor. 
MGI is defined as the geometric mean of the within-participant ratios of antibody titers. 
*Refer to Table 1, Table 2, and Table 3 for details on visits and intervals. 
Details related to attributes of estimands covering intercurrent events, population and 
treatment definition are provided in the Section 9. 
4. 
STUDY DESIGN 
4.1. 
Overall design 
The study design overview is presented in Figure 1. 
Experimental design: Phase 2b, randomized, multi-center, open-label study with three 
parallel groups (see Figure 1). 
Study groups and Randomization and enrollment rules: Approximately 375 eligible 
participants will be enrolled in the study, under the following groups. 
CCI
CCI
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
46 
• 
Approximately 250 IC adults ≥18 YoA who received a renal or lung SOT, will be 
randomly assigned (1:1) to the following 2 IC groups (1 dose versus 2 doses; 
125 participants each) at Visit 1 (Day 1). Each group may include approximately 
65% renal transplant patients and approximately 20% lung transplant patients, and 
the remaining patients can be freely distributed across the 2 groups. 
− 
RSV_IC_1 group: IC patients receiving 1 dose of RSVPreF3 OA 
investigational vaccine at Visit 1 (Day 1). 
− 
RSV_IC_2 group: IC patients receiving 2 doses of RSVPreF3 OA 
investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). 
• 
Approximately 125 healthy adults ≥50 YoA (distributed among age categories of 
50-59 YoA (30 %), 60-69 YoA (30%), ≥70 YoA (20%), and 20% to be freely 
distributed over the different age categories) will be assigned to the healthy 
participants group. 
− 
RSV_HA group: Healthy participants receiving 1 dose of RSVPreF3 OA 
investigational vaccine at Visit 1 (Day 1). 
Primary completion date: Visit 4 (1 month after the last study intervention 
administration). 
Duration of the study: The total duration of the study, per participant, will be 
approximately 13-15 months for the IC patients and 12 months for the healthy 
participants. 
Type of study: self-contained. 
Data collection: A standardized eCRF will be used. Solicited events will be collected as 
of the day of each study intervention administration and for 6 subsequent days. 
Unsolicited AEs, new concomitant medications/vaccinations will be collected as of the 
day of each study intervention administration and for 29 subsequent days. As of Day 30 
following each study intervention administration, the details are collected in source 
documents prior to entering them in the eCRF until study end. 
Safety monitoring: The study will be monitored by an IDMC as well as the project SRT 
(Refer Section 8.3.4 and Section 10.1.6). 
4.2. 
Scientific rationale for study design 
RSV is associated with serious illness in OA and high-risk adults, including those who 
are immunocompromised that may lead to increased risk of RSV-LRTD. The efficacy of 
a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-
LRTD in OA ≥60 YoA has been shown in the Phase 3 clinical study RSV OA=ADJ-006 
(refer to IB). 
Since the immune response in IC patients is often lower compared to healthy persons, the 
current study is designed as a Phase 2, open-label study to evaluate the immune response, 
safety, and reactogenicity of 1 versus 2 doses of RSVPreF3 OA investigational vaccine in 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
47 
an IC population (renal and lung SOT patients) ≥18 YoA and additionally comparing it to 
1 dose in healthy participants ≥50 YoA. 
The inclusion of the 1-dose group in the SOT patient groups will provide more robust 
information and will help to make an informed decision on the need to use 1 dose versus 
2 doses by comparing the immune response (in terms of GMT ratios in neutralization 
titers against RSV-A and RSV-B, as well as cell-mediated immunity) in the 1-dose group 
at Visit 3 and Visit 4 with the immune response in the 2-dose group at Visit 4. 
In addition, a comparison on humoral and cell-mediated immunity at all timepoints up to 
12 months post-last dose (including Month 6 and Month 12) between both groups of SOT 
patients as well as comparison to healthy participants will provide important information 
on waning of the immune response. In this study, the inclusion of a group of healthy 
adults ≥50 YoA will help to better elucidate the potential differences in immunogenicity 
and safety in the SOT patient groups versus healthy participants as of 50 YoA. Having 
head-to-head comparison with the healthy group will aid in the characterization of the 
immune response (both humoral and cell-mediated) of the IC population. Specifically for 
RSV, it is important that the healthy group is included in the same study since the primed 
status of the healthy adults and therefore the immune response to the vaccine, might 
differ between studies, as RSV seasonality can be different across countries/regions and 
years. Moreover, a head-to-head comparison with the healthy participants group will also 
enable further characterization of the reactogenicity of RSVPreF3 OA vaccine in IC 
population. 
4.2.1. 
Participant input into design 
Not applicable. 
4.3. 
Justification for dose 
A single dose (0.5 mL) or 2 doses of the licensed formulation (120 μg 
RSVPreF3/AS01E) will be used in this study. 
Since the immune response in immunocompromised patients is often lower compared to 
healthy persons, this study will investigate the impact of a second dose given 1-2 months 
apart from the first dose. Therefore, the current study is designed as a Phase 2, open-label 
study to evaluate the immune response, safety, and reactogenicity of RSVPreF3 OA 
investigational vaccine in IC patients ≥18 YoA following the first and the second dose 
and additionally comparing it to 1 dose in healthy adults ≥50 YoA. 
4.4. 
End of study definition 
A participant is considered to have completed the study if the participant has completed 
all periods of the study including the last visit. 
EoS: LSLV (Visit 6) or Date of the last testing/reading released of the Human Biological 
Samples, related to primary and secondary endpoints, whichever occurs later. EoS must 
be achieved no later than 8 months after LSLV. EoS cannot be before LSLV. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
48 
5. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted. 
Adherence to the inclusion and exclusion criteria specified in the protocol is essential. 
5.1. 
Inclusion criteria 
Participants are eligible to be included in the study only if all of the following criteria 
apply: 
5.1.1. 
Inclusion criteria for all participants 
All participants must satisfy ALL the following criteria at study entry: 
• 
Participants and/or participant’s parent(s)/LAR(s) who, in the opinion of the 
investigator, can and will comply with the requirements of the protocol (e.g., 
completion of the paper diary cards, return for follow-up visits, ability to access and 
utilize a phone or other electronic communications, have regular contact to allow 
evaluation during the study). 
Note: In case of physical incapacity that would preclude the self-completion of the 
diary cards, either site staff can assist the participant (for activities performed 
during site visits) or the participant may assign a caregiver to assist him/her with 
this activity (for activities performed at home). However, at no time will the site staff 
or caregiver evaluate the participant’s health status while answering diary cards or 
make decisions on behalf of the participant. Refer to Definition of Terms for the 
definition of caregiver. 
• 
Participants living in the general community or in an assisted-living facility that 
provides minimal assistance can be enrolled, such that the participant is primarily 
responsible for self-care and activities of daily living. 
• 
Written or witnessed informed consent obtained from the participant/participant’s 
parent(s)/LARs (participant must be able to understand the informed consent) prior 
to performance of any study-specific procedure. 
• 
Female participants of nonchildbearing potential may be enrolled in the study. 
Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, 
bilateral salpingectomy, and post-menopause. 
• 
Female participants of childbearing potential may be enrolled in the study if the 
participant 
− 
has practiced adequate contraception from 1 month prior to study intervention 
administration and agreed to continue adequate contraception until study end for 
this study, and 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
49 
− 
has a negative pregnancy test on the day of and prior to study intervention 
administration. 
Refer to Section 10.4.1 for definitions of women of childbearing potential, 
non-childbearing potential, menarche and menopause and Section 10.4.2 on 
adequate contraception. 
5.1.2. 
Specific inclusion criteria for renal/lung transplant patients 
• 
A male or female participant, ≥18 YoA at the time of signing the Informed consent 
form (ICF) or Informed assent form (IAF). 
• 
Written informed assent obtained from the participant (participant must be able to 
understand the informed assent) if he/she is less than legal age of consent*, or 
written informed consent obtained from the participant if the participant has achieved 
legal age of consent. 
*The legal age of consent is determined according to local regulations in each 
participating country. Assent must be obtained from the minor participant in 
addition to the consent provided by the participants’ parent(s)/LAR(s) when a minor 
can assent to participate in a study. If the legal age is achieved during the conduct of 
the study, an additional written informed consent from the participant should be 
obtained at that time. 
• 
Participant who has received an ABO compatible allogeneic renal or lung transplant 
(allograft) more than 12 months (365 days) prior to the first study intervention 
administration. 
• 
Participant receiving maintenance immunosuppressive therapy for the prevention of 
allograft rejection. 
5.1.3. 
Specific inclusion criteria for renal transplant (RTx) patients 
• 
Participant with stable renal function, stability defined as less than 20% variability 
between last two results of eGFR or in the opinion of the investigator after 
investigator review of more than the last two results of eGFRs and based on medical 
history. 
5.1.4. 
Specific inclusion criteria for lung transplant (LTx) patients 
• 
Participant with stable lung function, with stability defined as the stability in the 
FEV1 compared to post-transplant baseline FEV1 and based on medical history of 
the last 3 months, in the opinion of the investigator. 
5.1.5. 
Specific inclusion criteria for healthy participants 
• 
A male or female, ≥50 YoA at the time of signing the ICF. 
• 
Healthy participants as established by medical history and clinical examination 
before entering the study. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
50 
• 
Participants who are medically stable in the opinion of the investigator at the time of 
first study intervention administration. 
• 
Participants with chronic stable medical conditions with or without specific 
treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to 
participate in this study if considered by the investigator as medically stable. 
5.2. 
Exclusion criteria 
Participants are excluded from the study if any of the following criteria apply: 
5.2.1. 
Medical conditions 
• 
History of any reaction or hypersensitivity likely to be exacerbated by any 
component of the study intervention (For details on components of study 
intervention administered, refer to Table 8 and Arexvy SmPC/Prescribing 
information [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing 
Information, 2023]. 
• 
Acute or chronic clinically significant cardiovascular or hepatic functional 
abnormality as determined by physical examination or laboratory screening tests. 
• 
Recurrent or uncontrolled neurological disorders or seizures. Participants with 
medically controlled chronic neurological diseases can be enrolled in the study as per 
investigator assessment, provided that their condition will allow them to comply with 
the requirements of the protocol (e.g., completion of the diary cards, attend study site 
visits). Study participants may decide to assign a caregiver to help them complete 
some of the study procedures (Refer to Section 8). 
• 
Any history of dementia or any medical condition that moderately or severely 
impairs cognition. 
Note: If deemed necessary for clinical evaluation, the investigator can use tools such 
as Mini-Mental State Exam, Mini-Cog or Montreal Cognitive Assessment (to 
determine cognition levels of the participant). 
• 
Any condition which, in the judgment of the investigator, would make IM injection 
unsafe. 
• 
Significant underlying illness that in the opinion of the investigator would be 
expected to prevent completion of the study (e.g., life-threatening disease likely to 
limit survival up to study end). 
• 
Acute disease and/or fever at the time of study intervention administration. Fever is 
defined as temperature ≥ 38°C /100.4°F determined by oral or axillary route. 
However, participants with a minor illness (such as mild diarrhea, mild upper 
respiratory infection) without fever may be enrolled at the discretion of the 
investigator. 
• 
Bedridden participants. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
51 
• 
Any other clinical condition that, in the opinion of the investigator, might pose 
additional risk to the participant due to participation in the study. 
5.2.2. 
Prior/Concomitant therapy 
• 
Use of any investigational or non-registered product (drug, vaccine, or medical 
device) other than the study intervention administration during the period beginning 
30 days before the first dose of study intervention administration (Day -30 to Day 1), 
or their planned use during the study period (up to Visit 6). 
• 
Previous vaccination with the same antigen (RSV) containing vaccine as that of the 
study intervention, including investigational RSV vaccines. 
• 
Planned or actual administration of a vaccine not foreseen by the study protocol in 
the period starting 30 days before the first dose of study intervention administration 
and ending 30 days after the last dose of study intervention administration*. In the 
case of COVID-19 and inactivated/subunit/split influenza vaccines, this time 
window can be decreased to 14 days before and after each study intervention 
administration. 
*If emergency mass vaccination for an unforeseen public health threat (e.g., a 
pandemic) is recommended and/or organized by the public health authorities outside 
the routine immunization program, the time period of 30 days described above can 
be reduced, if necessary for that vaccine, provided it is used according to the local 
governmental recommendations and that the Sponsor is notified. 
5.2.3. 
Prior/Concurrent clinical study experience 
• 
Concurrently participating in another clinical study, at any time during the study 
period, in which the participant has been or will be exposed to an investigational or a 
non-investigational intervention (drug/invasive medical device). 
5.2.4. 
Other exclusion criteria 
• 
Pregnant or lactating female participant. 
• 
Female participant planning to become pregnant or planning to discontinue 
contraceptive precautions. 
• 
History of chronic alcohol consumption and/or drug abuse as deemed by the 
investigator to render the potential participant unable/unlikely to provide accurate 
safety reports or comply with study procedures. 
• 
Participation of any study personnel or their immediate dependents, family, or 
household members. 
• 
Planned move during the study period that will prohibit participating in the study 
until study end. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
52 
5.2.4.1. 
Specific exclusion criteria for renal/lung transplant patients: 
• 
More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) 
transplanted). Dual organ is allowed (double kidney or double lung). 
• 
History of events that, in the opinion of the investigator, may put the participant at 
increased risk for chronic allograft dysfunction. 
• 
Participant with an episode of allograft rejection over the previous 3 months 
(90 days) prior to the first study intervention administration. 
• 
Histologic evidence of chronic allograft injury. 
• 
Active treatment for acute rejection. 
• 
Current diagnosis of malignancy (except non-melanoma skin cancer that does not 
require systemic therapy). 
• 
Any autoimmune conditions or pIMDs that in the opinion of the investigator may put 
the participant at increased risk. 
• 
Any confirmed or suspected HIV infection or primary immunodeficiency disease or 
ongoing CMV infection with a viremia > 200 IU/mL. 
• 
Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as 
induction, maintenance and/or therapeutic immunosuppressive therapy for the 
prevention of allograft rejection within 9 months (274 days) of first dose of study. 
• 
Use of investigational and non-registered immunosuppressants at the local/country 
level, unless specifically prescribed for the prevention of allograft rejection, and 
which are non-registered and: 
− 
available locally through compassionate use programs, 
− 
submitted for and pending local/country registration, 
− 
approved and registered for use in other countries with well-documented SmPC 
or Prescribing Information. The name of the active component(s) of these 
immunosuppressants must be provided in the concomitant medication listing. 
• 
Evidence or high suspicion, in the opinion of the investigator, of noncompliance or 
nonadherence to use of induction and/or maintenance immunosuppressive therapies. 
• 
Any clinically significant* hematologic (hemoglobin level, white blood cell, 
lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte 
mean corpuscular volume) and/or biochemical (ALT, AST, creatinine, blood urea 
nitrogen) laboratory abnormality. 
* The investigator should use their clinical judgment to decide which abnormalities 
are clinically significant. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
53 
5.2.4.2. 
Specific exclusion criteria for RTx patients: 
• 
Previous allograft loss secondary to recurrent primary kidney disease. Multiple 
consecutive kidney transplants are allowed if the reason for a previous allograft loss 
is not recurrent primary kidney disease. 
• 
Evidence of significant proteinuria/albuminuria in the opinion of the investigator. 
5.2.4.3. 
Specific exclusion criteria for LTx patients: 
• 
At study intervention administration visit, diagnosis of documented acute pulmonary 
infection within the 2 prior weeks, based on the following: clinical, radiological, and 
physiological deterioration; OR isolation of an organism from a clinically relevant 
BAL fluid culture. 
• 
Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement 
of 20% or more in FEV1 compared to post-transplant baseline FEV1. 
5.2.4.4. 
Specific exclusion criteria for healthy participants: 
• 
Any confirmed or suspected immunosuppressive or immunodeficient condition 
resulting from disease (e.g., current malignancy, HIV) or immunosuppressive / 
cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ 
transplantation, or to treat autoimmune disorders), based on medical history and 
physical examination (no laboratory testing required). 
• 
Unstable serious chronic illness. 
• 
Chronic administration of immune-modifying drugs (defined as more than 
14 consecutive days in total) and/or administration of long-acting immune-modifying 
treatments or planned administration at any time up to the end of the study. 
− 
Up to 3 months prior to the study intervention administration: 
o 
For corticosteroids, this will mean prednisone equivalent ≥20 mg/day, or 
equivalent. Inhaled, topical and intra-articular steroids are allowed. 
o 
Administration of immunoglobulins and/or any blood products or plasma 
derivatives. 
− 
Up to 6 months prior to study intervention administration: long-acting immune-
modifying drugs including among others, immunotherapy (e.g., TNF-inhibitors), 
monoclonal antibodies, antitumoral medication. 
5.3. 
Lifestyle considerations 
No restrictions are required. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
54 
5.4. 
Screen failures 
A screen failure occurs when a participant who has consented to participate in the clinical 
study is not subsequently entered in the study. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to 
meet the CONSORT publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility 
criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) 
may be rescreened once. Rescreened participants should be assigned a new participant 
number at the rescreening event. Previously assigned participant number will be recorded 
in the participants’ eCRF. 
5.5. 
Criteria for temporarily delaying enrollment/ administration 
of study intervention 
Enrollment/study intervention administration may be postponed within the permitted visit 
interval until transient conditions cited below are resolved and before the end of 
recruitment period: 
• 
Participants (SOT patients) with any clinically significant (in the opinion of the 
investigator) hematologic/biochemical values out of normal range which are 
expected to be temporary may be retested once at a later date within the allowed visit 
interval. 
• 
Acute disease and/or fever at the time of study intervention administration. Refer to 
the SoA (Section 1.3) for definition of fever and preferred location for measuring 
temperature in this study. 
• 
Participants with a minor illness (such as mild upper respiratory infection, mild 
diarrhea) without fever may be enrolled and/or dosed at the discretion of the 
investigator. 
• 
In case of administration of vaccines, study intervention administration should be 
postponed, within given protocol timelines and prior to the end of the study 
enrollment period, to allow respect of at least 30 days interval between other 
vaccination and study intervention administration. 
• 
In case of administration of inactivated, subunit and split influenza vaccines or 
COVID-19 vaccines (fully licensed or with EUA): postponement of study 
intervention administration within given protocol timelines and prior to the end of 
the study enrollment period, to allow respect of at least 14 days interval between 
flu/COVID-19 vaccination and study intervention administration. 
• 
Participants with symptoms suggestive of active COVID-19 infection (e.g., fever, 
cough, etc.). The return of the participant to the site will follow the specific guidance 
from local public health and other competent authorities (e.g., free of symptoms, 
COVID-19 negative testing, etc.). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
55 
• 
Participants with known COVID-19 positive contacts may be dosed at least 14 days 
after the exposure, provided that the participant remains symptom-free, and at the 
discretion of the investigator. 
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY 
The definition of study intervention is provided in the Definition of Terms. 
6.1. 
Study intervention administered 
Study intervention administered is mentioned in Table 8 below. Refer to Section 4.1 for 
study intervention administration schedule. 
Table 8 
Study Intervention Administered 
Study intervention name: 
RSVPreF3 OA Investigational Vaccine 
Vaccines/ product formulation 
RSVPreF3 (120 µg) 
AS01E: QS-21* (25 µg), MPL (25 µg), 
liposomes; Water for injections 
Presentation 
Powder for suspension for 
injection (Vial) 
Suspension for suspension for 
injection (Vial) 
Type 
Study 
Product category 
Biologic 
Route of administration 
IM 
Administration site 
 
Location 
Deltoid 
Directionality  
Upper 
Laterality** 
Non-dominant 
Number of doses to be 
Administered 
1 dose (RSV_IC_1 and RSV_HA groups) 
2 doses (RSV_IC_2 group) 
Volume to be administered by dose*** 
0.5 mL 
Packaging and labeling 
Refer to Pharmacy Manual for details 
Manufacturer 
GSK 
AS01E = Adjuvant System 01; QS-21 = Quillaja saponaria Molina, fraction 21; MPL = Monophosphoryl lipid A. 
* Licensed by GSK from Antigenics Inc, a wholly owned subsidiary of Agenus Inc., a Delaware, USA corporation. 
** The non-dominant arm is the preferred arm of injection. In case it is not possible to administer the study intervention 
in the non-dominant arm, an injection in the dominant arm may be performed. 
*** Refer to the Pharmacy Manual for the volume after reconstitution. 
Study participants must be observed closely for at least 30 minutes after the 
administration of the study intervention. Appropriate medical treatment and equipment 
must be readily available during the observation period in case of anaphylaxis or 
syncope. 
6.1.1. 
Medical devices 
• 
There are no GSK manufactured medical devices (or devices manufactured for GSK 
by a third party) provided for use in this study. Other medical devices (not 
manufactured by or for GSK) provided for use in this study are thermometer for 
body temperature measurement, ruler for skin reaction measurement, materials for 
study intervention administration, syringes, blood collection kits, and cup for urine 
collection. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
56 
• 
Instructions for medical device use are provided in Laboratory Manual and 
Pharmacy Manual. 
• 
All device deficiencies (including malfunction, use error and inadequate labeling) 
shall be documented and reported by the investigator throughout the clinical 
investigation (see Section 8.4.7) and appropriately managed by GSK. 
6.2. 
Preparation, handling, storage, and accountability 
The investigator or designee must confirm appropriate conditions (e.g., temperature) have 
been maintained during transit for all study intervention received, and any discrepancies 
are reported and resolved before use of the study intervention. 
Only participants enrolled in the study may receive study intervention, and only 
authorized site staff may supply, prepare, or administer study intervention. If allowed by 
country regulation/ethics, study intervention may be administered by a HHS professional. 
All study intervention must be stored in a secure, environmentally controlled, and 
monitored (manual or automated) area in accordance with the labeled storage conditions 
with access limited to the investigator and authorized site staff. 
The investigator, institution, the head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, reconciliation, 
and record maintenance (i.e., receipt, reconciliation, and final disposition records). 
Further guidance and information for the final disposition of unused study interventions 
are provided in the pharmacy manual. 
6.3. 
Assignment to study intervention 
6.3.1. 
Participant identification 
Participant identification numbers will be assigned sequentially to the individuals who 
have consented to participate in the study. Each study center will be allocated a range of 
participant identification numbers. 
6.3.2. 
Randomization to study intervention 
Immunocompromised adults ≥18 YoA who received a renal or lung SOT will be 
randomly assigned in a 1:1 ratio at Visit 1 (Day 1) to RSV_IC_1 group or RSV_IC_2 
group to receive either 1 dose or 2 doses of the RSVPreF3 OA investigational vaccine, 
respectively. 
All participants in RSV_HA group (Healthy adults ≥50 YoA) will receive 1 dose of the 
RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). 
The assignment of clinical trial supplies will be performed using a GSK Randomization 
and Trial Supply Management (RTSM) system. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
57 
6.3.3. 
Intervention allocation to the participant 
The order of study intervention assignment is generated (permuted block randomization) 
and stratified by SOT type and CMI subset using a GSK RTSM system. The subject level 
study intervention assignment activity is conducted using a GSK RTSM system. 
Each IC group may include approximately 65% renal transplant patients and 
approximately 20% lung transplant patients, and the remaining patients can be freely 
distributed across the 2 groups. Recruitment caps for patient transplant populations are 
managed by the RTSM system. 
For the healthy participant group, participants will be enrolled in 3 age categories, with 
approximately 30% of participants 50-59 YoA, approximately 30% of participants 
60-69 YoA, and approximately 20% of participants ≥ 70 YoA. The remaining 20% can 
be distributed freely across the 3 age categories. Recruitment caps for age group 
populations are managed by the RTSM system. 
Within each group 30% participants will be assigned to CMI subset (See Section 6.3.4 for 
details). 
The RTSM system will assign randomisation number and corresponding study group at 
time of randomisation as well as the study intervention number at time of each study 
intervention administration. 
When RTSM system is not available, please refer to the Pharmacy Manual for 
instructions. 
Refer to the Pharmacy Manual for additional information about the study intervention 
number allocation. 
6.3.4. 
Allocation of participants to CMI assay subsets 
Participants contributing to the CMI subset will be recruited from a selected number of 
countries and selected number of clinical sites. In the selected sites, the investigator will 
allocate if possible, at Visit 1, the first participants in each group to the CMI subset until 
the allocated target is reached. The subsets are detailed in Table 9 below. 
Table 9 
Allocation to CMI subset 
Group 
Subset 
Number of participants 
RSV_IC_1 
CMI 
~38 
Non-CMI 
~87 
RSV_IC_2 
CMI 
~38 
Non-CMI 
~87 
RSV_HA 
CMI 
~38 
Non-CMI 
~87 
Total 
 
~375 
CMI = Cell-mediated immunity; HA = Healthy adults; IC = immunocompromised; RSV = Respiratory Syncytial Virus. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
58 
6.4. 
Blinding 
This is an open-label study; potential bias will be reduced by central randomization. 
6.5. 
Study intervention compliance 
Participants will receive study intervention at the site, directly from the investigator or 
designee, under medical supervision. The date and time of each dose administered in the 
clinic will be recorded in the source documents. 
A record of the quantity of RSVPreF3 OA Investigational Vaccine administered to each 
participant must be maintained and reconciled with study intervention and compliance 
records. 
6.6. 
Dose modification 
Not applicable. 
6.7. 
Continued access to study intervention after the end of the 
study 
There is no plan to provide continued access to the study intervention following the end 
of the study. 
6.8. 
Treatment of overdose 
Not applicable. 
6.9. 
Prior and concomitant therapy 
The following concomitant medication(s)/product(s)/vaccine(s) must be recorded in the 
eCRF: 
• 
All concomitant medication leading to elimination from the analysis, including 
products/vaccines. Please refer to the Section 5.2.2 for further details. 
• 
All concomitant medication which may explain/cause/be used to treat an 
SAE/pIMD/AESI including vaccines/products, as defined in Section 8.4 and 
Section 10.3.5.7. These must also be recorded in the Expedited AEs Report. 
• 
For all AF AESIs (including serious and non-serious), concomitant drugs which 
could be associated with development or worsening of AF must be reported in the 
AF follow-up questionnaire. 
• 
Any prophylactic medication (e.g., analgesics, antipyretics) administered on the day 
of study intervention administration (Day 1) in the absence of any symptom and in 
anticipation of a reaction to the study intervention administration. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
59 
• 
Any medication or vaccine (including over-the-counter or prescription medicines) or 
other specific categories of interest (immunosuppresive medication for SOT patients) 
that the participant is receiving at the time of enrollment or up to 30 days post-last 
study intervention administration must be recorded along with: 
− 
Reason for use (indication) 
− 
Dates of administration including start and end dates 
− 
Dosage information including dose and frequency 
• 
Any antipyretic administered in the period starting 6 hours before vaccination and 
ending 12 hours after vaccination needs to be recorded on the eCRF. 
The Medical monitor should be contacted if there are any questions regarding 
concomitant or prior therapy. 
Medications that are contraindicated for use in this study are stipulated in the exclusion 
criteria in Section 5.2.2, Section 5.2.4.1 and Section 5.2.4.4. 
Table 10 describes prohibited medications (that could impact evaluation of participants 
baseline status, safety and efficacy assessments) and the required washout period prior to 
study intervention administration. Generally, these medications are prohibited until after 
Visit 6, unless otherwise stated below. 
Medications that are not stipulated in the exclusion criteria or listed in Table 10 may be 
used based on the discretion of the investigator (after careful evaluation whether or not 
the medication could impact evaluation of the clinical trial objective or the safety of the 
participant). 
Table 10 
Prohibited medications and washout period 
Prohibited medications 
Washout period 
Investigational or non-registered product 
30 days prior to first dose until Visit 61 
Vaccine 
30 days prior to first dose until 30 days after last dose2 
Immune-modifying drugs >14 consecutive days in total3 
3 months prior to first dose until Visit 64 
Long-acting immune-modifying treatments (e.g., 
immunotherapy (e.g., TNF-inhibitors), monoclonal 
antibodies, antitumoral medication)3 
6 months prior to first dose until Visit 6 
Immunoglobulins and/or any blood products or plasma 
derivatives3 
3 months prior to first dose until Visit 6 
Anti-CD20 or other B-cell monoclonal antibody agents (e.g., 
rituximab) as induction, maintenance and/or therapeutic 
immunosuppressive therapy for the prevention of allograft 
rejection5 
9 months (274 days) prior to first dose until Visit 6 
1 For renal/lung transplant patients, the use of investigational and non-registered immunosuppressants at the 
local/country level are contraindicated, unless specifically prescribed for the prevention of allograft rejection, and 
which are non-registered and: available locally through compassionate use programs; submitted for and pending 
local/country registration; approved and registered for use in other countries with well-documented SmPC or 
Prescribing Information. 
2 Any vaccine. However, for COVID-19 and inactivated/subunit/split influenza vaccines (fully licensed or with 
emergency use authorisation [EUA]), this time window can be decreased to 14 days before and after each dose. If 
emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or 
organized by the public health authorities outside the routine immunization program, the time period of 30 days 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
60 
described above can be reduced, if necessary for that vaccine, provided it is used according to the local 
governmental recommendations and that the Sponsor is notified. Live attenuated vaccines should not be 
administered throughout the study for SOT patients as a part of SoC. 
3 Applicable only for healthy participants. 
4 For corticosteroids, this will mean prednisone equivalent ≥20 mg/day, or equivalent. Please note: Inhaled, topical and 
intra-articular steroids are allowed. 
5 Applicable only for SOT patients. 
Table 11 
Timing of collection of concomitant medication to be recorded 
 
Dose 1 
Study conclusion 
(Visit 6 at Month 12-15) 
 
Day 1 
Day 30 
All concomitant medication including vaccines/products, except 
vitamins and dietary supplements# 
 
 
 
All concomitant medication including products/vaccines leading 
to elimination from the applicable analysis 
 
 
 
All concomitant medication including vaccines/products which 
may explain/cause/be used to treat an SAE/pIMD/AESI* 
 
 
 
Any prophylactic medication# 
 
 
 
AESI = Adverse event of special interest; AF = Atrial Fibrillation; pIMD = Potential immune-mediated disease; SAE = 
Serious adverse event. 
Note: The collection period for the concomitant medications to be recorded in eCRF is indicated in gray. 
# For the RSV_IC_2 group, the time period corresponds to both dose 1 and dose 2 of study intervention administration. 
* For all AF AESIs (including serious and non-serious), concomitant drugs which could be associated with development 
or worsening of AF must be reported in the AF follow-up questionnaire. 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of study intervention 
Discontinuation of study intervention refers to any participant who has not received all 
planned doses of the study intervention. In rare instances, it may be necessary for a 
participant to permanently discontinue study intervention. If study intervention is 
permanently discontinued, the participant should, if possible, continue other study 
procedures (e.g., safety or immunogenicity), planned in the study protocol at the 
discretion of the investigator. 
The primary reason for premature discontinuation of the study intervention will be 
documented in the eCRF based on the list below: 
Reasons 
Additional items/Sub-reasons 
AE 
Unsolicited AE 
Solicited AE 
SAEs / pIMDs /AESIs 
Lost to follow-up 
Withdrawal by Participant 
Burden of Procedure 
Participant Relocated 
COVID-19 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
61 
Reasons 
Additional items/Sub-reasons 
Other, Specify 
Investigator Decision 
Specify 
Protocol Deviation 
Specify 
Site Terminated by Sponsor 
 
Study Terminated by Sponsor 
Pregnancy 
 
Death 
 
Other 
Specify 
AE = Adverse event; AESI = Adverse event of special interest; COVID-19 = Coronavirus disease; pIMD = Potential 
immune-mediated disease; SAE = Serious adverse event. 
7.1.1. 
Contraindications to subsequent study intervention 
administration 
The eligibility for subsequent study intervention administration must be confirmed before 
administering any additional dose. 
Participants who meet any of the criteria listed below or criteria listed in Sections 5.2.1 
and 5.2.2 should not receive additional doses of study intervention. Such participants 
should be encouraged to continue other study procedures, at the investigator’s discretion. 
All relevant criteria for discontinuation of study intervention administration must be 
recorded in the eCRF. 
• 
Participants who experience any SAE judged to be possibly or probably related to 
study intervention or non-study concomitant vaccine/product, including 
hypersensitivity reactions. 
• 
Participants who develop any new condition which, in the opinion of the 
investigator, may pose additional risk to the participants if they continue to 
participate in the study. 
• 
Anaphylaxis following the administration of study intervention. 
• 
Condition that in the judgment of the investigator would make intramuscular 
injection unsafe. 
• 
Occurrence of a new pIMD or the exacerbation of an existing pIMD that, in the 
opinion of the investigator, expose the participant to unacceptable risk from 
subsequent vaccination. In such cases, the investigator should use their clinical 
judgment prior to administering the next dose of the study intervention. Refer to 
Section 8.4.4.1 for the definition of pIMD. 
• 
Occurrence of a new AESI or the exacerbation of an existing AESI that, in the 
opinion of the investigator, exposes the participant to unacceptable risk from 
subsequent doses of study intervention. Refer to Section 8.4.4 for the definition of 
AESI. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
62 
• 
Pregnant or lactating female participant (Refer to Section 8.4.6). 
7.2. 
Participant discontinuation/withdrawal from the study 
A participant may withdraw from the study at any time at the participant’s own request 
for any reason (or without providing any reason). 
A participant may be withdrawn at any time at the discretion of the investigator for 
safety, behavioral, or compliance reasons. 
Investigators will attempt to contact participants who do not return for scheduled visits or 
follow-up. 
All data and samples collected up to and including the date of withdrawal of/last contact 
with the participant will be included in the study analyses. If the participant withdraws 
consent for disclosure of future information, the sponsor may retain and continue to use 
any data collected before such a withdrawal of consent. 
A participant can request for the destruction of their samples any time during the study. 
The investigator must document the request in the site study records. If a participant 
withdraws from the study, any samples taken and not tested, should not be tested, and 
should be destroyed, if applicable, as per local regulations. 
The primary reason for participant discontinuation/ withdrawal from the study will be 
documented in the eCRF based on the list below: 
Reasons 
Additional items/Sub-reasons 
AE 
Unsolicited AE 
Solicited AE 
SAEs / pIMDs /AESIs 
Lost to follow-up 
Withdrawal by Participant 
Burden of Procedure 
Participant Relocated 
COVID-19 
Other, Specify 
Investigator Decision 
Specify 
Protocol Deviation 
Specify 
Site Terminated by Sponsor 
Study Terminated by Sponsor 
Pregnancy 
 
Death 
 
Other 
Specify 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
63 
AE = Adverse event; AESI = Adverse event of special interest; COVID-19 = Coronavirus disease; pIMD = Potential 
immune-mediated disease; SAE = Serious adverse event. 
Participants who are withdrawn from the study because of AEs/SAEs must be clearly 
distinguished from participants who are withdrawn for other reasons. Investigator will 
follow participants who are withdrawn from the study due to an AE/SAE/AESI until the 
event is resolved, stabilized, otherwise explained, or the participant is lost to follow-up 
(see Section 10.3.5.5). 
7.3. 
Lost to follow-up 
A participant will be considered lost to follow-up if the participant repeatedly fails to 
return for scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a 
required study visit: 
• 
The site must attempt to contact the participant/caregiver and reschedule the missed 
visit as soon as possible, within the allowed visit interval, counsel the participant on 
the importance of maintaining the assigned visit schedule and ascertain whether the 
participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant/caregiver (where possible, 
3 telephone calls, and if necessary, a certified letter to the participant’s last known 
mailing address or local equivalent methods). These contact attempts should be 
documented in the participant’s medical record. 
• 
Should the participant continue to be unreachable, the participant will be considered 
to have withdrawn from the study. 
• 
Site personnel, or an independent third party, will attempt to collect the vital status of 
the participant within legal and ethical boundaries for all participants randomized, 
including those who did not get study intervention. Public sources may be searched 
for vital status information. If vital status of the participant is determined as 
deceased, this will be documented and the participant will not be considered lost to 
follow-up. Sponsor personnel will not be involved in any attempts to collect vital 
status information. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
• 
Study procedures and their timing are summarized in the SoA (Section 1.3). Protocol 
waivers or exemptions are not allowed. 
• 
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
• 
Immediate safety concerns should be discussed with the sponsor as soon as they 
occur or when the study team becomes aware of them. In case of doubts of 
immediate safety concerns regarding the inclusion of a possible participant, inclusion 
should be postponed until a decision can be made. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
64 
• 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. Subjects who have signed informed consent 
but are not eligible to proceed should be recorded in the eCRF with a status of 
‘screen failure’. The investigator will maintain a log of all participants screened. All 
relevant information, such as confirmation of eligibility and reasons for screening 
failure will be mentioned in this screening log. 
• 
Procedures conducted as part of the participant’s routine clinical management (e.g., 
blood count) and obtained before signing of the ICF, and those conducted during the 
entire duration of the study may be utilized for screening or baseline purposes, as 
well as for safety follow-up (e.g., SoC tests to assess occurrence of allograft rejection 
in SOT patients) provided the procedures met the protocol-specified criteria and 
were performed within the timeframe defined in the SoA. 
• 
Study participants may decide to assign a caregiver to help them complete the study 
procedures. Please refer to the Definition of Terms for the definition of a caregiver. 
− 
A caregiver can be appointed by the participant at any time during the study, 
when the participant feels it is necessary. Caregiver should receive the caregiver 
information letter before providing support to the study participant. Ideally, a 
single caregiver should be appointed by the participant but, in some situations, it 
may happen that several caregivers will support a study participant throughout 
the conduct of the study. This should be recorded in the source documents. 
However, every effort should be done to ensure that only one caregiver enters 
the data into the paper diary to allow for timely completion. 
− 
Caregivers may help the study participants with performing some practical study 
procedures such as receiving or making phone calls to site staff, planning study 
visits, transcribing responses to diaries, transportation to and from the study site 
etc. However, at no time, the caregiver should evaluate the participant’s health 
status while answering diaries or make decisions on behalf of the participant. At 
the first study visit, the site staff should inform the participant of the possibility 
to appoint a caregiver. Then at subsequent study visit(s), the site staff should 
check again with the participants if they wish to appoint a caregiver or if there 
were or will be changes of caregiver. 
• 
In the event of a significant study-continuity issue (e.g., caused by a pandemic), 
alternate strategies for participant visits, assessments, study intervention distribution 
and monitoring may be implemented by the sponsor or the investigator, as per local 
health authority/ethics requirements. 
• 
It is preferred to have all visits on-site. However, during special circumstances (e.g., 
COVID-19 pandemic, SOT patients in whom health has deteriorated during the 
study, or for whom the transfer to the clinic has become very difficult), the specific 
guidance from local public health, if applicable, and other competent authorities 
regarding the protection of individuals’ welfare must be applied and consulted with 
the sponsor. For the duration of such special circumstances, the following measures 
may be implemented for enrolled participants: 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
65 
− 
Follow-up visits (Visit 3 in HA and IC 1-dose groups, and Visits 2, 4, 5, and 6 
for all groups) may be conducted at the participant’s home (by the site staff or 
by a home care service system), if appropriate. If home visits are not possible, 
telephone calls or other means of virtual contacts may be used. 
− 
Diary cards may be transmitted from and to the site by electronic means or 
courier service if allowed by local regulations and or conventional mail or 
collected at home. Biological samples may be collected at participant’s home. 
Biological samples should not be collected if they cannot be processed in a 
timely manner or appropriately stored until the intended use. Home Visits are 
not allowed for participants in the CMI subset (due to time-sensitivity of CMI 
samples) except in special circumstances and with the prior approval of the GSK 
central study team. 
• 
Impact of visits performed outside of the site’s location on the PPS for 
immunogenicity will be determined on a case-by-case basis. 
• 
The maximum amount of blood collected from each participant over the duration of 
the study, related to procedures in this study, will not exceed 288 mL. Repeat or 
unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
8.1. 
Administrative and baseline procedures 
8.1.1. 
Collection of demographic data 
Record demographic data such as year of birth, age at the time of study intervention 
administration, sex, race*, and ethnicity* in the participant’s eCRF. 
Collection of sex, race and ethnicity data is necessary to assess and monitor the diversity 
of the trial participants, and to determine if the trial participants are truly representative of 
the impacted population. 
*Differences in the safety and efficacy of certain medical products, including vaccines 
[Haralambieva, 2013; Pérez-Losada, 2009; Kollmann, 2013] have been observed in 
racially and ethnically distinct subgroups. These differences may be attributable to 
intrinsic factors (e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, 
environmental exposure, sociocultural issues), or interactions between these factors. 
Therefore, both geographic ancestry (race) and ethnicity will be collected for all study 
participants. 
Age is collected to stratify the population and determine the impact of the study 
intervention by age. 
8.1.2. 
 Medical/vaccination history 
Obtain the participant’s relevant medical/vaccination history by interviewing the 
participant/participant’s parent(s)/LAR(s) and/or review of the participant’s 
medical/vaccination records. Record any relevant pre-existing conditions, signs and/or 
symptoms present prior to the study intervention in the eCRF. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
66 
Any vaccine administered up to 1 year before study vaccine administration should be 
recorded in the eCRF with date of vaccination. For history of influenza vaccination, 
information about the vaccine formulation (e.g., adjuvanted or non-adjuvanted or 
highdose) should be recorded. 
Administration of Shingrix at any timepoint (even if longer than 1 year before the study 
vaccine administration) should be recorded in the eCRF. The date of vaccinations should 
be collected and recorded in the eCRF. 
Specifically additional data will be collected for transplant participants as listed in 
Section 8.1.3. 
8.1.3. 
Record specific participant transplant information 
The following information will be recorded (if available in medical history of the 
lung/renal transplant recipient patient) and entered into the eCRF at screening visit: 
Current transplant history 
Information will be collected and entered eCRF about the current transplant, including: 
• 
Type of transplant (one or two kidneys, one or two lungs) 
• 
Date of transplantation 
• 
Biopsies since transplantation (Yes/No), and if yes, 
− 
collect the results indicating rejection and type of rejection (Acute or Chronic) 
• 
Current allograft function with options (stable for 3 to ≤6 months, stable for 6 to 
≤12 months, or stable for >12 months) 
Previous transplant 
Information will be collected and entered eCRF about the previous transplants (if any 
before the current), including: 
• 
Type of transplant (one or two kidneys, one or two lungs) 
• 
Date of transplantation 
• 
Data about allograft loss (Yes/No), and if yes, 
− 
collect the reasons for allograft loss 
In case of multiple previous transplantations, all previous transplantations should be 
recorded with the information as above. 
8.1.4. 
Record height and weight 
Measure the participant’s height and weight and record the values in the eCRF. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
67 
8.1.5. 
Targeted physical examination/history-directed physical 
examination 
A history-directed physical examination will be performed for each participant at the 
screening visit in SOT patients and Visit 1 in healthy participants. At each subsequent 
visit, a targeted physical examination will be performed, as needed. 
If the investigator determines that the participant’s health on the day of study intervention 
administration temporarily precludes dosing, the visit will be rescheduled. Refer to 
Section 5.5 for the list of criteria for temporary delay of study intervention 
administration. Treatment of any abnormality observed during this examination has to be 
performed according to local medical practice outside this study or by referral to an 
appropriate health care provider. 
Collected information needs to be recorded in the eCRF. 
A targeted physical examination at each study visit after the first study intervention 
administration will be performed if part of the SoC or only if the participant/participant’s 
parent(s)/LAR(s) indicates during questioning that there might be some underlying 
pathology(ies) or if deemed necessary by the investigator or delegate. 
8.1.6. 
Vital signs 
At minimum, temperature, vital signs (e.g., heart rate, respiratory rate, and blood 
pressure) will be recorded. 
Vital signs are to be taken after at least 10 minutes of rest and before blood collection for 
laboratory tests (if applicable) and will consist of systolic/diastolic blood pressure, heart 
rate and respiratory rate by counting the number of breaths for 1 minute before 
vaccination at Visit 1 and Visit 3. 
Blood pressure and pulse measurements will be assessed with a completely automated 
device. Manual techniques will be used only if an automated device is not available. 
In case of increased blood pressure (i.e., systolic BP ≥ 140 mm Hg, and /or diastolic BP 
≥90 mm Hg) the measurements of 3 consecutive blood pressure readings will be recorded 
at intervals of at least 1 minute. The average of the 3 blood pressure readings will be 
recorded [Smith, 2005]. 
Collected information needs to be recorded in the eCRF. 
If the investigator determines that the participant’s health on the day of study intervention 
administration temporarily precludes dosing, the visit will be rescheduled. Vital signs 
will be re-taken in case of delayed vaccination. Refer to the Section 5.5 for the list of 
criteria for temporary delay of study intervention administration. 
The body temperature of each participant needs to be measured prior to study 
intervention administration and recorded in the eCRF. The location for measuring 
temperature will be oral or axillary. If the participant has fever (defined as temperature 
≥38.0°C/100.4°F regardless of the location of measurement) on the day of study 
intervention administration, the visit will be rescheduled (refer to Section 5.5 for details). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
68 
8.1.7. 
Allograft rejection 
Participants will be instructed to contact the study site or their health care provider if they 
develop signs or symptoms perceived as allograft dysfunction, rejection, or failure, as 
explained by their transplant physician(s). 
Participants, after notifying the study site of possible allograft dysfunction, rejection, or 
failure, will undergo the study site’s standard clinical procedures for the diagnosis of 
possible rejection. These allograft diagnostic tests, including any biopsies, will be 
considered “clinically indicated”. 
In addition to clinically indicated testing and as part of the management of the transplant, 
allograft function testing and biopsies may be routinely performed, as per center-defined 
protocol and timetable for surveillance. These tests will be considered as performed per 
“surveillance protocol” and recorded into eCRF screen. 
Allograft rejection will be recorded as an AESI in the Expedited AEs Report. The 
following information on allograft rejection is to be included in eCRF screens: 
• 
Start date as based on: 
− 
Date of first appearance of clinical symptoms indicative of rejection, resulting in 
a “clinically indicated” biopsy or 
− 
Date of “surveillance protocol” biopsy. 
• 
Pertinent medical evaluations with results, including: 
− 
Allograft biopsy - date, histological results 
− 
Clinical laboratories 
− 
Imaging 
• 
Medical management including but not limited to: 
− 
procedures 
− 
changes in immunosuppressive medications 
• 
End date of the rejection event. 
• 
Outcome: not recovered/not resolved (ongoing, stabilized, progressing [e.g., allograft 
rejection progressing to failure]), recovering/resolving/disappearing, 
recovered/resolved. 
8.1.7.1. 
Record estimated glomerular filtration rate (eGFR) and 
proteinuria/albuminuria (only in RTx patients) 
Local laboratory ranges on eGFR and proteinuria/albuminuria including equations used 
to calculate eGFR or conversions used for proteinuria/albuminuria should be provided to 
the sponsor prior to study start. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
69 
eGFR and proteinuria/albuminuria measures (as obtained per SoC “surveillance 
protocols” and/or for “clinical indications”) will be recorded: 
• 
Record all available eGFR from SoC, as of screening visit, so that at least 
2 measurements are recorded prior to the first study intervention administration, and 
continue to record during the entire study and, 
• 
Record all available results on proteinuria/albuminuria from SoC, starting from the 
day of first study intervention administration, backward so that at least 
2 measurements are recorded prior to the first study intervention administration and 
continue to record during the entire study. 
The eGFR results will be collected as well as their corresponding dates and their 
interpretation (staging), see Section 10.5.1. 
The proteinuria/albuminuria results will be collected in mg/g units as well as their 
corresponding dates and their interpretation (staging), see Section 10.5.2. 
8.1.7.2. 
Record bronchoscopy and/or transbronchial lung biopsy (TBBx) (only 
in LTx patients) 
In some countries bronchoscopy is the SoC test to assess possible signs of rejection in 
LTx patients. In case the bronchoscopy results (measures as obtained per SoC 
“surveillance protocols” and/or for “clinical indications”) are available, they will be 
recorded. If TBBx have been requested by SoC or by indication, the results will be also 
recorded. 
The results of bronchoscopy will be collected as well as their corresponding dates and 
their interpretation (classification), see Sections 10.5.3 and 10.5.4. 
8.1.7.3. 
Record FEV1 (only in LTx patients) 
In LTx patients, the FEV1 results (measures as obtained at site per SoC “surveillance 
protocols” and/or for “clinical indications”) will be recorded as well as their 
interpretation in staging the CLAD. The FEV1 results will be collected as well as their 
corresponding dates and their interpretation (classification), see Section 10.5.5. 
8.1.7.4. 
Imaging results (RTx and LTx patients) 
In some countries, imaging such as CT-Scan, MRI, X-Ray, ultrasound or other, is a SoC 
test to assess possible signs of rejection in Tx patients. In case the imaging results 
(measured as obtained per SoC “surveillance protocols” and/or for “clinical indications”) 
are available, they will be recorded in the eCRF, including their timestamp and summary 
of the results. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
70 
8.1.7.5. 
Biopsy results (RTx and LTx patients) 
In case biopsies are taken to assess the possible onset of rejection (either acute or 
chronic), a summary of the results as well as indication of showing rejection, will be 
recorded in the eCRF. 
8.2. 
Immunogenicity assessments 
Biological samples will be used for research planned in the protocol and for purposes 
related to the improvement, development and quality assurance of the laboratory tests 
described in this protocol. 
Findings in this or future studies may make it desirable to use samples acquired in this 
study for research not planned in this protocol. In this case, all participants in countries 
where this is allowed will be asked to give consent to allow GSK or a contracted partner, 
to use the samples for further research. The further research will be subject to prior 
IEC/IRB approval, if required by local legislation. 
Information on further research and its rationale can be obtained from GSK. 
Sample testing will be done in accordance with the recorded consent of the individual 
participant/participant’s parent(s)/LAR(s). 
By default, collected samples will be stored for a maximum of 20 years. This storage 
period begins when the last participant performs the last study visit. This timeline can be 
adapted based on local laws, regulations or guidelines requiring different timeframes or 
procedures. In all cases, the storage period should be aligned with participant’s consent. 
These additional requirements must be formally communicated to, discussed and agreed 
with GSK. 
Planned timepoints for all immunogenicity assessments are provided in the SoA 
(Section 1.3). 
8.2.1. 
Biological samples 
An overall maximal volume of 288 mL of blood will be collected per participant during 
the entire study period (12-15 months). Refer to Table 12 and SoA (Section 1.3) for 
information on volumes collected for different assessments. 
Table 12 
Biological samples 
Sample type 
Quantity 
Unit 
Timepoint 
Subset name 
Blood for 
Hematology and 
Biochemistry 
~6 
mL 
Screening Visit 
IC population 
Blood for HI 
(neutralizing titers 
against RSV-A, 
RSV-B) 
~8.5 
mL 
Visit 1 
Visit 2* 
Visit 3 
Visit 4 
Visit 5 
All Participants 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
71 
Sample type 
Quantity 
Unit 
Timepoint 
Subset name 
Blood for 
Hematology and 
Biochemistry 
~6 
mL 
Screening Visit 
IC population 
Visit 6 
Blood for CMI 
~30 
mL 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
CMI subset 
Urine for 
pregnancy test 
- 
- 
Screening Visit** 
Visit 1 
Visit 3*** 
WOCBP 
CMI = Cell-mediated immunity; HI = Humoral Immunity; IC = Immunocompromised; 
 
; RSV = Respiratory Syncytial Virus. WOCBP = Women of Childbearing Potential 
* Only for CMI subset (Refer Section 6.3.4) 
** Only for IC population. 
*** Only for IC-2 dose group. 
8.2.2. 
Laboratory assays 
Table 13 
Laboratory assays 
Test 
Classification 
System 
Component 
Challenge 
Method 
Laboratory 
CMI 
PBMC 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-α, 
IFN-γ, IL-13, and IL-17  
Peptide pool 
covering the 
RSVPreF3 
protein 
sequence  
ICS 
GSK* 
Humoral 
immunity 
(antibody 
determination) 
Serum 
RSV-A neutralizing titers 
Neutralization 
GSK* 
RSV-B neutralizing titers 
CCI
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
72 
Test 
Classification 
System 
Component 
Challenge 
Method 
Laboratory 
Hematology 
Blood 
Leukocytes (white blood cells) 
Neutrophils 
Lymphocytes 
Basophils 
Monocytes 
Eosinophils 
Hemoglobin 
Platelets 
Erythrocytes (red blood cells) 
As per central 
laboratory 
procedure 
Central Lab 
Biochemistry 
Serum 
Alanine Aminotransferase (ALT) 
Aspartate Aminotransferase (AST) 
Creatinine 
eGFR (Refer 10.5.1 for definition) 
Blood Urea Nitrogen 
As per central 
laboratory 
procedure 
Central Lab 
CD = Cluster of differentiation; CD40L = CD40 ligand; CMI = Cell-mediated immunity; 
 
; eGFR = estimated glomerular filtration rate; GSK = GlaxoSmithKline Biologicals S.A.; 
 
; ICS = Intracellular cytokine staining; IFN = Interferon; IL = Interleukin; 
 
; PBMC = Peripheral blood mononuclear cell; RSV = Respiratory Syncytial Virus; TNF = 
Tumor necrosis factor. 
* GSK laboratory refers to the clinical laboratory sciences (CLS) in Rixensart, Belgium; Wavre, Belgium. CLS may 
delegate testing to GSK Research laboratories in Rixensart, Belgium; Rockville, USA; Siena, Italy or to a 
contracted CRO. 
Please refer to Section 10.2 for a brief description of the assays performed in the study. 
The addresses of clinical laboratories used for sample analysis are provided in a separate 
document accompanying this study protocol. 
GSK clinical laboratories have established a Quality System supported by procedures. 
The activities of GSK clinical laboratories are audited regularly for quality assessment by 
an internal (sponsor-dependent) but laboratory-independent Quality Department. 
8.2.3. 
Immunological read-outs 
Table 14 
Immunological read-outs 
Blood sampling time point 
Subset name 
No. of 
participants 
Component 
Type of contact and time 
point 
Sampling time 
point 
Humoral immunity (on serum samples) 
Visit 1 (Day 1) 
Pre-dose-1 
All participants 
375 
RSV-A neutralization 
RSV-B neutralization 
Visit 2 (V1 + 7-14 days) 
Post-dose-1 
CMI subset 
114 
RSV-A neutralization 
RSV-B neutralization  
Visit 3 (V1 + 30-60 days) 
Post-dose-1 
All participants 
375 
RSV-A neutralization 
RSV-B neutralization 
Visit 4 (V3 + 30-42 days) 
Post-dose-1/-2 All participants 
375 
RSV-A neutralization 
RSV-B neutralization 
Visit 5 (V1/V3 + 180-210 days) Post-dose-1/-2 All participants 
375 
RSV-A neutralization 
RSV-B neutralization 
Visit 6 (V1/V3 + 350-380 days) Post-dose-1/-2 All participants 
375 
RSV-A neutralization 
RSV-B neutralization 
CCI
CCI
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
73 
Blood sampling time point 
Subset name 
No. of 
participants 
Component 
Type of contact and time 
point 
Sampling time 
point 
CMI (on PBMC samples) 
Visit 1 (Day 1) 
Pre-dose-1 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
Visit 2 (V1 + 7-14 days) 
Post-dose-1 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
Visit 3 (V1 + 30-60 days) 
Post-dose-1 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
Visit 4 (V3 + 30-42 days) 
Post-dose-1/-2 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
Visit 5 (V1/V3 + 180-210 days) Post-dose-1/-2 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
Visit 6 (V1/V3 + 350-380 days) Post-dose-1/-2 
CMI subset 
114 
CD4+ and CD8+ T cells expressing 
immune or activation markers 
among CD40L, 4-1BB, IL-2, TNF-
α, IFN-γ, IL-13, and IL-17 
CD = Cluster of differentiation; CD40L = CD40 ligand; CMI = Cell-mediated immunity; IFN = Interferon; IL = Interleukin; 
RSV = Respiratory Syncytial Virus; TNF = Tumor necrosis factor. 
8.2.4. 
Cytology 
Not applicable. 
8.2.5. 
Immunological correlates of protection 
No generally accepted immunological correlate of protection has been demonstrated so 
far for the antigen used in the RSVPreF3 OA investigational vaccine. 
8.3. 
Safety assessments 
Planned timepoints for all safety assessments are provided in the SoA (Section 1.3). 
8.3.1. 
Clinical safety laboratory tests 
See Section 10.2 for the list of clinical laboratory tests to be performed in accordance 
with lab manual and the SoA (Section 1.3). 
The investigator must review the laboratory results from screening and document this 
review. The laboratory results must be retained with source documents. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
74 
Abnormal laboratory findings associated with the underlying disease at screening are not 
considered clinically significant unless judged by the investigator to be more severe than 
expected for the participant’s condition. In this case, the SOT patient can not be included 
in the study. 
8.3.3. 
Pregnancy testing 
A urine pregnancy test must be performed for female participants of childbearing 
potential before the administration of any dose of study intervention. Pregnancy testing 
must be done even if the participant is menstruating at the time of the study visit. The 
study intervention may only be administered if the pregnancy test is negative. 
Refer to Section 8.4.6 for the information on study continuation for participants who 
become pregnant during the study. 
8.3.4. 
Safety monitoring and Committee 
Participant safety will be continuously monitored by the Medical monitor and the 
designated Safety Lead (or delegate), Safety Review Team (SRT) and IDMC throughout 
the study. Pertinent findings and conclusions are shared with the product’s SRT for 
review of the overall benefit-risk profile of the product. 
This study will include lung and renal transplant recipient patients which are a special 
population within the group of IC patients because of the specific risk of organ rejection. 
Therefore, an IDMC which includes clinicians with expertise in lung and renal transplant 
will review safety data and provide recommendations to the team. The IDMC charter will 
describe the timing and the frequency of the meetings, the required data review and 
documentation of the safety evaluations. 
Safety data will be summarized and reviewed by the IDMC, according to the IDMC 
charter, for agreement of next steps. 
8.4. 
Adverse events (AEs), serious adverse events (SAEs), and 
other safety reporting 
For definitions relating to safety information see Section 10.3. 
The investigator and any qualified designees are responsible for detecting, documenting, 
and recording events that meet the definition of an AE or SAE and other safety 
information and remain responsible for following up all AEs. This includes events 
reported by the participant (or, when appropriate, by a caregiver). 
CCI

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
75 
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSARs) according to local regulatory requirements and sponsor policy and 
forwarded to investigators as necessary. 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.3. 
8.4.1. 
Time period and frequency for collecting AE, SAE, and other 
safety information 
All AEs and SAEs will be collected at the time points specified in the SoA (Section 1.3). 
AF reporting will follow the same reporting periods as for AEs and SAEs. Non-serious 
AF with an onset during the 30-day period following each study vaccine administration 
will be collected. The reporting of AF meeting the SAE definition (serious AF) will be 
performed according to the SAE reporting period. 
SAEs assessed as related to study participation (e.g., protocol-mandated procedures, 
invasive tests, or change in existing therapy) or related to a GSK product (non-IMP) will 
be recorded from the time a participant consents to participate in the study. 
Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded as medical history/current medical conditions, not as 
AEs. 
All SAEs will be recorded and reported to the sponsor or designee immediately and under 
no circumstance should this exceed 24 hours, as indicated in Section 10.3. The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. A post-study AE/SAE is defined as any event that occurs outside of the 
AE/SAE reporting period defined in Section 8.4.1/ Table 15 and Table 16.

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
76 
Table 15 
Timeframes for collecting and reporting of safety information in IC 1-dose group and healthy participant group 
Type of contact 
Screening Visit (for 
IC population only)* 
Visit 1 
Visit 2** 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Allowed interval 
-30 to -7 days 
Day 1 (pre-
vaccination) * Day 1 
Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 1 + 
180-210 days 
Visit 1 + 
350-380 
days 
Solicited administration site and systemic 
events (within 7 days after study 
intervention administration) 
 
 
 
 
 
 
 
 
Unsolicited AEs (within 30 days after 
study intervention administration)^ 
 
 
 
 
 
 
 
 
SAEs related to study participation*** or 
concurrent GSK medication/vaccine 
 
 
 
 
 
 
 
 
All SAEs^, all pIMDs, pregnancies, and 
(S)AEs leading to withdrawal from the 
study 
 
 
 
 
 
 
 
 
Intercurrent medical conditions 
 
 
 
 
 
 
 
 
AESIs specific for renal/lung transplant^^  
 
 
 
 
 
 
 
AE = Adverse event; AESI = Adverse event of special interest; AF = Atrial fibrillation; IC = Immunocompromised; pIMD = Potential immune-mediated disease; SAE = Serious adverse 
event. 
* Corresponds to the day when informed consent is obtained (Day 1, prior to study intervention administration in healthy participants, and at screening visit in IC population). 
** Visit 2 is planned in the CMI subset of the study population (30% of the group population i.e., 38 participants in each group). 
*** Any SAEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests such as blood sampling) or related to a GSK product will be recorded from 
the time a participant consents to participate in the study. 
^ AF will be considered as AESI in this study and will be additionally reported in the AF follow-up questionnaire in eCRF. The reporting of non-serious AF will be performed according to 
the unsolicited AE reporting period. The reporting of AF meeting the SAE definition (serious AF) will be performed according to the SAE reporting period. Fatal AF and Serious AF 
judged as related to study vaccination will be reported according to the fatal SAE and related SAE reporting period, respectively. 
^^ Corresponds only to the IC population. These AESIs include signs for allograft rejection. 
The shaded regions in the table indicate time period of data collection. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
77 
Table 16 
Timeframes for collecting and reporting of safety information in IC 2-dose group 
Type of contact 
Screening Visit* Visit 1 
Visit 2** 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Allowed interval 
-30 to -7 days 
Day 1 (pre-
vaccination) Day 1 Visit 1 + 
7-14 days 
Visit 1 + 
30-60 days 
Visit 3 + 
30-42 days 
Visit 3 + 
180-210 days 
Visit 3 + 
350-380 days 
Solicited administration site and systemic 
events (within 7 days after each study 
intervention administration) 
 
 
 
 
 
 
 
 
Unsolicited AEs (within 30 days after each 
study intervention administration)^ 
 
 
 
 
 
 
 
 
SAEs related to study participation*** or 
concurrent GSK medication/vaccine 
 
 
 
 
 
 
 
 
All SAEs^, all pIMDs, pregnancies, and (S)AEs 
leading to withdrawal from the study 
 
 
 
 
 
 
 
 
Intercurrent medical conditions 
 
 
 
 
 
 
 
 
AESIs specific for renal/lung transplant^^ 
 
 
 
 
 
 
 
 
AE = Adverse event; AESI = Adverse event of special interest; AF = Atrial fibrillation; IC = Immunocompromised; pIMD = Potential immune-mediated disease; SAE = Serious adverse 
event. 
* Corresponds to the day when informed consent is obtained. 
** Visit 2 is planned in the CMI subset of the study population (30% of the group population i.e., 38 participants). 
*** Any SAEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests such as blood sampling) or related to a GSK product will be recorded from 
the time a participant consents to participate in the study. 
^ AF will be considered as AESI in this study and will be additionally reported in the AF follow-up questionnaire in eCRF. The reporting of non-serious AF will be performed according to 
the unsolicited AE reporting period. The reporting of AF meeting the SAE definition (serious AF) will be performed according to the SAE reporting period. Fatal AF and Serious AF 
judged as related to study vaccination will be reported according to the fatal SAE and related SAE reporting period, respectively. 
^^ These AESIs include signs for allograft rejection. 
The shaded regions in the table indicate time period of data collection. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
78 
Investigators are not obligated to actively seek information on AEs or SAEs after 
conclusion of the study participation. However, if the investigator learns of any SAE, 
including a death, after a participant has been discharged from the study, the investigator 
must record it in the medical records. If the investigator considers the event to be 
reasonably related to the study intervention or study participation, the investigator must 
promptly notify the sponsor. 
8.4.2. 
Method of detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and SAEs. Open-ended and 
nonleading verbal questioning of the participant/participant’s parent(s)/LAR(s) is the 
preferred method to inquire about AE occurrences. 
8.4.3. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs and AESIs (as defined in 
Section 8.4.4) will be followed until resolution, stabilization, the event is otherwise 
explained, or the participant is lost to follow-up (as defined in Section 7.3). For AF cases, 
the investigator will provide any new or updated relevant information on previously 
reported AF during the study to GSK using a paper/electronic Expedited AEs Report and 
the AF follow-up questionnaire as applicable. Further information on follow-up 
procedures is provided in Section 10.3.5.5. 
8.4.4. 
AESIs 
8.4.4.1. 
Potential immune-mediated diseases 
Potential immune-mediated diseases (pIMDs) are a subset of AESIs that include 
autoimmune diseases and other inflammatory and/or neurologic disorders of interest 
which may or may not have an autoimmune etiology. AEs that need to be recorded and 
reported as pIMDs include those listed in Table 17. 
In order to facilitate the documentation of pIMDs in the eCRF, a pIMD standard 
questionnaire and a list of preferred terms (PTs) and PT codes corresponding to the above 
diagnoses will be available to investigators at study start. 
The investigator(s) must exercise their medical/scientific judgment to determine whether 
other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or 
organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. In 
addition, the investigator should categorize each pIMD either as a new onset condition (if 
it started following vaccination) or as an exacerbation of a pre-existing chronic condition 
(if it exacerbated following vaccination) in the eCRF. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
79 
Table 17 
List of potential immune-mediated diseases (pIMDs) 
Medical Concept 
Additional Notes 
Blood disorders and coagulopathies 
Antiphospholipid syndrome 
 
Autoimmune aplastic anemia 
 
Autoimmune hemolytic anemia 
• 
Includes warm antibody hemolytic anemia and cold antibody 
hemolytic anemia 
Autoimmune 
lymphoproliferative syndrome 
(ALPS) 
 
Autoimmune neutropenia  
 
Autoimmune pancytopenia 
 
Autoimmune thrombocytopenia 
• 
Frequently used related terms include: “autoimmune 
thrombocytopenic purpura”, “idiopathic thrombocytopenic 
purpura (ITP)”, “idiopathic immune thrombocytopenia”, “primary 
immune thrombocytopenia”. 
Evans syndrome 
 
Pernicious anemia 
 
Thrombosis with 
thrombocytopenia syndrome 
(TTS) 
 
Thrombotic thrombocytopenic 
purpura 
• 
Also known as “Moschcowitz-syndrome” or “microangiopathic 
hemolytic anemia” 
Cardio-pulmonary inflammatory disorders 
Idiopathic 
Myocarditis/Pericarditis 
Including but not limited to: 
• 
Autoimmune / Immune-mediated myocarditis 
• 
Autoimmune / Immune-mediated pericarditis 
• 
Giant cell myocarditis 
Idiopathic pulmonary fibrosis 
Including but not limited to: 
• 
Idiopathic interstitial pneumonia (frequently used related terms 
include “Interstitial lung disease”, “Pulmonary fibrosis”, “Immune-
mediated pneumonitis”) 
• 
Pleuroparenchymal fibroelastosis (PPFE) 
Pulmonary alveolar proteinosis 
(PAP) 
• 
Frequently used related terms include: “pulmonary alveolar 
lipoproteinosis”, “phospholipidosis” 
Endocrine disorders 
Addison’s disease 
 
Autoimmune / Immune-
mediated thyroiditis  
Including but not limited to: 
• 
Hashimoto thyroiditis (autoimmune hypothyroidism, lymphocytic 
thyroiditis) 
• 
Atrophic thyroiditis 
• 
Silent thyroiditis 
• 
Thyrotoxicosis 
Autoimmune diseases of the 
testis and ovary 
• 
Includes autoimmune oophoritis, autoimmune ovarian failure and 
autoimmune orchitis 
Autoimmune hyperlipidemia 
 
Autoimmune hypophysitis 
 
Diabetes mellitus type I 
 
Grave's or Basedow’s disease 
• 
Includes Marine Lenhart syndrome and Graves’ ophthalmopathy, 
also known as thyroid eye disease (TED) or endocrine 
ophthalmopathy 
Insulin autoimmune syndrome 
 
Polyglandular autoimmune 
syndrome 
• 
Includes Polyglandular autoimmune syndrome type I, II and III 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
80 
Medical Concept 
Additional Notes 
Eye disorders 
Ocular Autoimmune / Immune-
mediated disorders 
Including but not limited to: 
• 
Acute macular neuroretinopathy (also known as acute macular 
outer retinopathy) 
• 
Autoimmune / Immune-mediated retinopathy 
• 
Autoimmune / Immune-mediated uveitis, including idiopathic 
uveitis and sympathetic ophthalmia 
• 
Cogan’s syndrome: an oculo-audiovestibular disease 
• 
Ocular pemphigoid 
• 
Ulcerative keratitis 
• 
Vogt-Koyanagi-Harada disease 
Gastrointestinal disorders 
Autoimmune / Immune-
mediated pancreatitis 
 
Celiac disease 
 
Inflammatory Bowel disease  
Including but not limited to: 
• 
Crohn’s disease 
• 
Microscopic colitis 
• 
Terminal ileitis 
• 
Ulcerative colitis 
• 
Ulcerative proctitis 
Hepatobiliary disorders 
Autoimmune cholangitis 
 
Autoimmune hepatitis 
 
Primary biliary cirrhosis 
 
Primary sclerosing cholangitis 
 
Musculoskeletal and connective tissue disorders  
Gout 
• 
Includes gouty arthritis 
Idiopathic inflammatory 
myopathies 
Including but not limited to: 
• 
Dermatomyositis 
• 
Inclusion body myositis 
• 
Immune-mediated necrotizing myopathy 
• 
Polymyositis 
Mixed connective tissue 
disorder 
 
Polymyalgia rheumatica (PMR) 
 
Psoriatic arthritis (PsA) 
 
Relapsing polychondritis 
 
Rheumatoid arthritis  
Including but not limited to: 
• 
Rheumatoid arthritis associated conditions 
• 
Juvenile idiopathic arthritis 
• 
Palindromic rheumatism 
• 
Still’s disease 
• 
Felty’s syndrome 
Sjögren’s syndrome 
 
Spondyloarthritis 
Including but not limited to: 
• 
Ankylosing spondylitis 
• 
Juvenile spondyloarthritis 
• 
Keratoderma blenorrhagica 
• 
Psoriatic spondylitis 
• 
Reactive Arthritis (Reiter’s Syndrome) 
• 
Undifferentiated spondyloarthritis 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
81 
Medical Concept 
Additional Notes 
Systemic lupus Erythematosus  
• 
Includes Lupus associated conditions (e.g., Cutaneous lupus 
erythematosus, Lupus nephritis, etc.) or complications such as 
shrinking lung syndrome (SLS) 
Systemic Scleroderma 
(systemic sclerosis) 
• 
Includes Reynolds syndrome (RS), systemic sclerosis with diffuse 
scleroderma and systemic sclerosis with limited scleroderma (also 
known as CREST syndrome) 
Neuroinflammatory/neuromuscular disorders 
Acute disseminated 
encephalomyelitis (ADEM) and 
other inflammatory 
demyelinating variants  
Includes the following: 
• 
Acute necrotizing myelitis 
• 
Bickerstaff’s brainstem encephalitis 
• 
Disseminated necrotizing leukoencephalopathy (also known as 
Weston-Hurst syndrome, acute hemorrhagic leuko-encephalitis, or 
acute necrotizing hemorrhagic encephalomyelitis) 
• 
Myelin oligodendrocyte glycoprotein antibody-associated disease 
• 
Neuromyelitis optica (also known as Devic’s disease) 
• 
Noninfective encephalitis / encephalomyelitis / myelitis 
• 
Postimmunization encephalomyelitis  
Guillain-Barré syndrome (GBS) 
• 
Includes variants such as Miller Fisher syndrome and the acute 
motor and sensory axonal neuropathy (AMSAN) 
Idiopathic cranial nerve 
palsies/paresis and 
inflammations (neuritis) 
Including but not limited to: 
• 
Cranial nerve neuritis (e.g., Optic neuritis) 
• 
Idiopathic nerve palsies/paresis (e.g., Bell’s palsy) 
• 
Melkersson-Rosenthal syndrome 
• 
Multiple cranial nerve palsies/paresis  
Multiple sclerosis (MS) 
Includes the following: 
• 
Clinically isolated syndrome (CIS) 
• 
Malignant MS (the Marburg type of MS) 
• 
Primary-progressive MS (PPMS) 
• 
Radiologically isolated syndrome (RIS) 
• 
Relapsing-remitting MS (RRMS) 
• 
Secondary-progressive MS (SPMS) 
• 
Uhthoff’s phenomenon  
Myasthenia gravis 
• 
Includes ocular myasthenia and Lambert-Eaton myasthenic 
syndrome 
Narcolepsy 
• 
Includes narcolepsy with or without presence of unambiguous 
cataplexy 
Peripheral inflammatory 
demyelinating neuropathies and 
plexopathies 
Including but not limited to: 
• 
Acute Brachial Radiculitis (also known as Parsonage-Turner 
Syndrome or neuralgic amyotrophy) 
• 
Antibody-mediated demyelinating neuropathy 
• 
Chronic idiopathic axonal polyneuropathy (CIAP) 
• 
Chronic Inflammatory Demyelinating Polyradiculoneuropathy 
(CIDP), including atypical CIDP variants (e.g., multifocal acquired 
demyelinating sensory and motor neuropathy also known as 
Lewis-Sumner syndrome) 
• 
Multifocal motor neuropathy (MMN)  
Transverse myelitis I 
• 
Includes acute partial transverse myelitis (APTM) and acute 
complete transverse myelitis (ACTM) 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
82 
Medical Concept 
Additional Notes 
Renal disorders 
Autoimmune / immune-
mediated glomerulonephritis  
Including but not limited to: 
• 
IgA nephropathy 
• 
IgM nephropathy 
• 
C1q nephropathy 
• 
Fibrillary glomerulonephritis 
• 
Glomerulonephritis rapidly progressive 
• 
Membranoproliferative glomerulonephritis 
• 
Membranous glomerulonephritis 
• 
Mesangioproliferative glomerulonephritis 
• 
Tubulointerstitial nephritis and uveitis syndrome 
Skin and subcutaneous tissue disorders 
Alopecia areata 
 
Autoimmune / immune-
mediated blistering dermatoses  
Including but not limited to: 
• 
Bullous Dermatitis 
• 
Bullous Pemphigoid 
• 
Dermatitis herpetiformis 
• 
Epidermolysis bullosa acquisita (EBA) 
• 
Linear IgA-mediated bullous dermatosis (LABD), also known as 
Linear IgA disease 
• 
Pemphigus  
Erythema multiforme 
 
Erythema nodosum 
 
Reactive granulomatous 
dermatitis  
Including but not limited to 
• 
Interstitial granulomatous dermatitis 
• 
Palisaded neutrophilic granulomatous dermatitis 
Lichen planus 
• 
Includes liquen planopilaris 
Localized Scleroderma 
(Morphoea) 
• 
Includes Eosinophilic fasciitis (also called Shulman syndrome) 
Psoriasis 
 
Pyoderma gangrenosum 
 
Stevens-Johnson syndrome 
(SJS) 
Including but not limited to: 
• 
Toxic Epidermal Necrolysis (TEN) 
• 
SJS-TEN overlap 
Sweet’s syndrome 
• 
Includes Acute febrile neutrophilic dermatosis 
Vitiligo 
 
Vasculitis 
Large vessels vasculitis  
Including but not limited to: 
• 
Arteritic anterior ischemic optic neuropathy (AAION or arteritic 
AION) 
• 
Giant cell arteritis (also called temporal arteritis) 
• 
Taka’asu's arteritis  
Medium sized and/or small 
vessels vasculitis  
Including but not limited to: 
• 
Anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis 
(type unspecified) 
• 
Be’cet's syndrome 
• 
Buerger’s disease (thromboangiitis obliterans) 
• 
Churg–Strauss syndrome (allergic granulomatous angiitis) 
• 
Erythema induratum (also known as nodular vasculitis) 
• 
Henoch-Schonlein purpura (also known as IgA vasculitis) 
• 
Microscopic polyangiitis 
• 
Necrotizing vasculitis 
• 
Polyarteritis nodosa 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
83 
Medical Concept 
Additional Notes 
• 
Single organ cutaneous vasculitis, including leukocytoclastic 
vasculitis, hypersensitivity vasculitis and acute hemorrhagic 
edema of infancy (AHEI) 
• 
Wegener’s granulomatosis  
Other (including multisystemic) 
Anti-synthetase syndrome 
 
Capillary leak syndrome 
• 
Frequently used related terms include: “systemic capillary leak 
syndrome (SCLS)” or “Clarkson’s Syndrome” 
Goodpasture syndrome 
• 
Frequently used related terms include: “pulmonary renal 
syndrome” and “anti-Glomerular Basement Membrane disease 
(anti-GBM disease)” 
Immune-mediated enhancement 
of disease 
• 
Includes vaccine associated enhanced disease (VAED and 
VAERD). Frequently used related terms include “vaccine-mediated 
enhanced disease (VMED)”, “enhanced respiratory disease 
(ERD)”, “vaccine-induced enhancement of infection”, “disease 
enhancement”, “immune enhancement”, and “antibody-dependent 
enhancement (ADE) 
Immunoglobulin G4 related 
disease 
 
Langerhans’ cell histiocytosis 
 
Multisystem inflammatory 
syndromes 
Including but not limited to: 
• 
Kawasaki’s disease 
• 
Multisystem inflammatory syndrome in adults (MIS-A) 
• 
Multisystem inflammatory syndrome in children (MIS-C)  
Overlap syndrome 
 
Raynaud’s phenomenon 
 
Sarcoidosis 
• 
Includes Loefgren syndrome 
Susac’s syndrome 
 
8.4.4.2. 
Atrial fibrillation (AF) 
AEs of AF are considered as AESI in this study. 
In the efficacy study (RSV OA=ADJ-006), at the time of safety analysis (data lock point 
[DLP]) of 30 April 2022, a numerical imbalance in events of AF was observed within 
30 days post-vaccination, with 10 events of AF (among which 7 [0.1%] were serious) in 
the RSVPreF3 group versus 4 (among which 1 [<0.1%] was serious) in the placebo 
group. No imbalance was observed for serious events of AF reported within 6 months 
post-vaccination. To further characterize events of AF, AF will be considered as an 
AESI. 
When there is enough evidence to make the above diagnosis, the AE must be reported as 
AESI. Symptoms, signs or conditions which might (or might not) represent AF, should be 
recorded and reported as AEs but not as AESI until the final or definitive diagnosis has 
been determined, and alternative diagnoses have been eliminated or shown to be less 
likely. 
For each case of AF reported in the AE or SAE section in the eCRF, additional 
information will be collected in a specific ‘AF follow-up questionnaire’ eCRF screen. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
84 
8.4.4.3. 
AESI for Transplant patients 
Within the framework of the study, transplant rejection that occurs at any time during the 
study will be considered and recorded as an AESI. 
Transplant rejection occurs when transplanted tissue is rejected by the recipient’s 
immune system, which destroys the transplanted tissue. Diagnosis of rejection relies on 
patient signs and symptoms, laboratory data, imaging or other technical procedures 
and/or tissue biopsies. The investigator will take into consideration all available 
information, including biopsy results, to decide whether or not organ rejection occurs. 
Clinically, management of allograft rejection will be as per local standard of care. 
Any form of rejection should be recorded and reported to the sponsor or designee as 
indicated in Section 10.3. 
When there is enough evidence to make any of the above diagnoses, the AE must be 
reported as AESI. Symptoms, signs or conditions which might (or might not) lead to one 
of the above diagnoses, should be recorded and reported as AEs but not as AESIs until 
the final or definitive diagnosis has been made, and alternative diagnoses eliminated or 
shown to be less likely. 
8.4.5. 
Regulatory reporting requirements for SAEs/pregnancies/AESIs 
Prompt notification by the investigator to the sponsor of an SAE/pregnancy/AESI is 
essential so that legal obligations and ethical responsibilities toward the safety of 
participants and the safety of a study intervention under clinical investigation are met. 
See Section 8.4.1 for reporting timeframes. 
For SAEs/AESIs, the investigator must always provide an assessment of causality at the 
time of the initial report, as defined in Section 10.3.5.6. 
An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (e.g., summary or listing of SAEs) from the sponsor will 
review and then file it along with the IB and will notify the IRB/IEC, if appropriate 
according to local requirements. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
85 
Table 18 
Timeframes for submitting SAEs, pregnancies and AESIs to GSK 
Type of event 
Initial reports 
Follow-up of relevant information on a 
previous report 
Timeframe 
Documents 
Timeframe 
Documents 
SAEs 
24 hours* 
electronic AEs Report 
24 hours* 
electronic AEs Report 
Pregnancies 
24 hours* 
electronic pregnancy report  
24 hours* 
electronic pregnancy report 
AESIs  
24 hours**  
electronic AEs Report 
24 hours* 
electronic AEs Report 
Serious AF***  
24 hours** 
electronic AEs Report + AF 
follow-up questionnaire 
24 hours* 
electronic AEs Report + AF 
follow-up questionnaire 
* Timeframe allowed after receipt or awareness of the information by the investigator/site staff. 
** Timeframe allowed once the investigator determines that the event meets the protocol definition of an AESI. 
*** Only AF meeting SAE definition will be reported in electronic AEs Report and in the specific AF follow-up 
questionnaire. Non-serious AF will be reported in the non-serious adverse event eCRF screen and in the AF 
follow-up questionnaire. 
8.4.6. 
Pregnancy 
Female participants who become pregnant after the first study intervention dose must not 
receive subsequent doses of the study intervention but may continue other study 
procedures at the discretion of the investigator. 
Female participants who become pregnant after administration of the study intervention 
may continue other study procedures at the discretion of the investigator. 
Details of all pregnancies in female participants will be collected after the start of study 
intervention and until end of study (refer Section 5.1 for details). 
If a pregnancy is reported, the investigator will record pregnancy information on the 
appropriate form and submit it to the sponsor within 24 hours of learning of the female 
participant’s pregnancy. 
Any pregnancy complication or elective termination of a pregnancy for medical reasons 
will be reported as an AE or SAE. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered SAEs and will be reported as 
such.The participant will be followed to determine the outcome of the pregnancy. The 
investigator will collect follow-up information on the participant and the neonate and the 
information will be forwarded to the sponsor. See Table 18 for reporting timeframes. 
Any post-study pregnancy-related SAE considered reasonably related to the study 
intervention by the investigator will be reported to the sponsor as described in 
Section 8.4.4. While the investigator is not obligated to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous reporting. 
Any female participant who becomes pregnant while participating in the study will 
discontinue study intervention. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
86 
8.4.7. 
Contact information for reporting SAEs, AESIs and pregnancies 
Table 19 
Contact information for reporting SAEs, AESIs and pregnancies 
Study contact for questions regarding SAEs, AESIs, pregnancies and SAEs linked 
to device deficiencies 
Contact GSK’s local and/or medical contacts 
Contacts for reporting SAEs, AESIs, pregnancies and SAEs linked to device 
deficiencies 
Available 24/24 hours and 7/7 days 
ogm28723@gsk.com 
8.4.8. 
Participant card 
The investigator (or designee) must provide the participant/participant’s parent(s)/LAR(s) 
with a “participant card” containing information about the clinical study. The 
participant/participant’s parent(s)/LAR(s) must be instructed to always keep the 
participant card in their possession for the duration of the study. In an emergency, this 
card serves to inform the responsible attending physician/LAR/caregiver that the 
participant is in a clinical study and that relevant information may be obtained by 
contacting the investigator(s) or their back up. 
8.5. 
Pharmacokinetics 
PK is not evaluated in this study. 
8.6. 
Pharmacodynamics 
PD is not evaluated in this study. 
8.7. 
Genetics 
Genetics are not evaluated in this study. 
8.8. 
Biomarkers 
Biomarkers are not evaluated in this study. 
8.9. 
Immunogenicity assessments 
Immunogenicity is described in Section 8.2 
8.10. 
Health economics or medical resource utilization and health 
economics 
Not applicable for this study. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
87 
9. 
STATISTICAL CONSIDERATIONS 
9.1. 
Statistical Hypotheses 
The primary objective, as outlined in Section 3, will be addressed using an estimation 
approach with no hypothesis testing. For the primary estimand, descriptive analysis will 
be utilized. 
9.2. 
Analysis sets 
Analysis sets are presented in Table 20. 
Table 20 
Analysis sets 
Analysis Set 
Definition / Criteria 
Analyses 
Evaluated 
Screened 
Set 
All participants who were screened for eligibility. 
Study Population 
Enrolled Set 
All participants who entered the study (who were randomized or received 
study intervention administration or underwent a post-screening study 
procedure). 
NOTE: screening failures (who never passed screening even if rescreened) 
and participants screened (met eligibility) but never enrolled into the study 
are excluded from the Enrolled Set as they did not enter the study. 
Study Population 
Exposed Set 
(ES) 
All participants who received the study intervention administration. Analysis 
per group is based on medical condition (IC versus healthy adults) and 
according to the randomization (RSV_IC_1 versus RSV_IC_2 group).. 
Study Population, 
Safety 
Per Protocol 
Set* (PPS) 
All eligible participants 
• 
who received the study intervention administration as per protocol 
• 
had immunogenicity results pre- and post-dose 
• 
complied with blood draw intervals 
• 
without intercurrent conditions that may interfere with immunogenicity 
• 
without prohibited concomitant medication/vaccination. 
Analysis per group is based on medical condition (IC versus healthy adults) 
and according to the randomization (RSV_IC_1 versus RSV_IC_2 group). 
Immunogenicity 
* Contribution of participants to PPS will be defined by timepoint. 
9.2.1. 
Criteria for elimination from analysis 
If the participant meets one of the criteria mentioned below or ones listed in the 
Section 7.1.1 (contraindication to subsequent vaccination) or 5.2.1 (medical conditions) 
or 5.2.2 (concomitant therapy), he/she may be eliminated from per protocol analysis. 
In case of administration of any medication mentioned in Section 5.2.2 during the study, 
this will be considered as a protocol deviation and the participant may be eliminated from 
the PPS. 
Participants may be eliminated from the PPS for immunogenicity if, during the study, 
they incur a condition that has the capability of altering their immune response 
(intercurrent medical condition) or are confirmed to have an alteration of their initial 
immune status. Refer to Definition of Terms for the definition of intercurrent medical 
conditions. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
88 
9.3. 
Statistical analyses 
This section is a summary of the planned statistical analyses of the primary and 
secondary endpoints. Supportive analyses and demography summaries will be described 
in the SAP. 
9.3.1. 
Primary endpoints/estimands analyses 
The co-primary endpoints/estimands are described in Section 3. The primary analysis will 
be performed on the PPS. 
MGI, i.e., the geometric mean of the within-participant ratios, of serum neutralizing titers 
against RSV-A and RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3) will be 
computed with their 95% CI in the RSV_IC_2 group. 
CIs for MGI will be based on a back transformation of CI for the mean of the difference 
between log10-transformed values, assuming that log-transformed values are normally 
distributed with unknown variance. 
Missing data will not be imputed. 
9.3.2. 
Secondary endpoints/estimands analyses 
Refer to Section 3 for the definition of secondary immunogenicity (humoral and CMI 
response) and safety endpoints. The immunogenicity analysis will be based on the PPS 
and safety analysis will be based on the ES. 
For humoral immune response, the following analysis will be tabulated for each 
immunological assay (RSV-A and RSV-B neutralization titers): 
• 
Percentage of participants above predefined threshold and GMT, with 95% CI, at 
pre-study intervention administration (Visit 1), Visit 2 (in a subset of participants), 
Visit 3, Visit 4, Visit 5, and Visit 6 in all groups. 
• 
GMT ratio (RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 
group) with 95%CI, at Visit 2 (in a subset of participants) and Visit 3. 
• 
GMT ratio (RSV_IC_2 group over RSV_IC_1 group) with 95% CI, at Visit 4, Visit 
5, and Visit 6. 
• 
GMT ratio (RSV_HA group over RSV_IC_1 group) with 95% CI, at Visit 4, Visit 5, 
and Visit 6. 
• 
GMT ratio (RSV_HA group over RSV_IC_2 group) with 95%CI, at Visit 4, Visit 5, 
and Visit 6. 
• 
MGI (RSV_IC group [pooled RSV_IC_1 and RSV_IC_2 group] and RSV_HA 
group) with 95% CI, at Visit 2 (in a subset of participants) over Visit 1, and at Visit 3 
over Visit 1. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
89 
• 
MGI (RSV_IC_1, RSV_IC_2 and RSV_HA group) with 95% CI, at Visit 4, Visit 5 
and Visit 6 over Visit 1. 
The GMT ratios and their 95% CIs will be derived from an ANCOVA model on log10-
transformed titers (details will be provided in the SAP). 
The following analysis will be tabulated by group for CMI response in the CMI subset: 
• 
Descriptive statistics (N, geometric mean, min, Q1, median, Q3, max) for the 
frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 
2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, 
TNF-α, IFN-γ, IL-13, IL-17 at pre-study intervention administration (Visit 1), Visit 
2, Visit 3, Visit 4, Visit 5, and Visit 6 in all groups. 
Descriptive safety analysis by group will be summarized as follows: 
• 
Percentage of participants reporting each solicited administration site event and 
solicited systemic event during a 7-day follow-up period (i.e., on the day of study 
intervention administration and 6 subsequent days) after each study intervention 
administration. 
• 
Percentage of participants reporting unsolicited AEs during a 30-day follow-up 
period (i.e., on the day of study intervention administration and 29 subsequent days) 
after each study intervention administration by MedDRA Primary System Organ 
Class (SOC), High Level Term (HLT) and Preferred Term (PT). 
• 
Percentage of participants reporting SAEs from study intervention administration 
(Day 1) up to study end (Visit 6) by MedDRA Primary SOC, HLT and PT. 
• 
Percentage of participants reporting pIMDs from study intervention administration 
(Day 1) up to study end (Visit 6) by MedDRA Primary SOC, HLT and PT. 
• 
Percentage of participants reporting SAEs related to study intervention 
administration from study intervention administration (Day 1) up to study end 
(Visit 6) by MedDRA Primary SOC, HLT and PT. 
• 
Percentage of participants reporting pIMDs related to study intervention 
administration from study intervention administration (Day 1) up to study end 
(Visit 6) by MedDRA Primary SOC, HLT and PT. 
• 
Percentage of participants reporting fatal SAEs from study intervention 
administration (Day 1) up to study end (Visit 6) by MedDRA Primary SOC, HLT 
and PT. 
• 
Percentage of participants reporting AESIs (specific to renal and lung SOT patients) 
from study intervention administration (Day 1) up to study end (Visit 6) by 
MedDRA Primary SOC, HLT and PT. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
90 
• 
Percentage of participants reporting demyelinating disorder during a 30-day follow-
up period (i.e., on the day of study intervention administration and 29 subsequent 
days) after each study intervention administration by MedDRA Primary SOC, HLT 
and PT. 
• 
Percentage of participants reporting demyelinating disorder SAE from study 
intervention administration (Day 1) up to study end (Visit 6) by MedDRA Primary 
SOC, HLT and PT. 
Exact 95% CIs around percentages will be computed using the method of Clopper and 
Pearson [Clopper, 1934]. 
9.4. 
Interim analysis 
9.4.1. 
Sequence of analyses 
The following analyses will be performed stepwise: 
• 
PCA (Primary completion analysis): A first analysis will be performed on all 
immunogenicity, reactogenicity and safety data available and as clean as possible, 
when data for at least primary and secondary endpoints up to Visit 4 are available. 
This analysis will be considered as final for those endpoints*. 
• 
Month 6 post-last dose: A second analysis will be performed on all immunogenicity 
and safety data available and as clean as possible, when data for at least secondary 
endpoints up to Visit 5 are available. This analysis will be considered as final for 
those endpoints*. 
• 
An end of study analysis will be performed when all data for at least secondary 
endpoints up to study conclusion (Visit 6) will be available. 
* Each analysis can be considered as final, as it is based on data that is as clean as 
possible. However, the consecutive analysis of the same time point might slightly 
differ at the next analysis e.g., when Month 6 data are re-analyzed at the time of 
Month 12 analysis. If major changes are identified, they will be described in the 
clinical study report. 
9.4.2. 
Statistical considerations for interim analysis 
This section is not applicable. 
9.5. 
Pre-dose sample size determination 
Approximately 375 eligible participants will be enrolled in the study, under the following 
groups: 
• 
Approximately 250 IC adults ≥18 YoA who received a renal or lung SOT, will be 
randomly assigned (1:1) to the following 2 IC groups (1 dose versus 2 doses; 
125 participants each) at Visit 1 (Day 1). Each group may include approximately 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
91 
65% renal transplant patients and approximately 20% lung transplant patients, and 
the remaining patients can be freely distributed across the 2 groups. 
− 
RSV_IC_1 group: N = 125; IC patients receiving 1 dose of vaccine at Visit 1. 
− 
RSV_IC_2 group: N = 125; IC patients receiving 2 doses of vaccine; first dose 
at Visit 1 and second dose at Visit 3. 
• 
Approximately 125 healthy adults ≥50 YoA (distributed among age categories of 
50-59 YoA (30%), 60-69 YoA (30%), ≥70 YoA (20%), and 20% to be freely 
distributed over the different age categories) will be assigned to the healthy adults 
group. 
− 
RSV_HA group: N = 125; healthy adults ≥50 YoA receiving 1 dose of vaccine 
at Visit 1. 
A 20% attrition rate is accounted from enrolled to evaluable participants. 
9.5.1. 
Sample size justification 
The study is aimed at describing the immune responses and exploring potential 
differences, between the immune response of IC patients (either after 1 or 2 doses of RSV 
vaccine) and the immune response of healthy participants. Given the descriptive nature of 
the study, no multiplicity adjustment is implemented. The sample size for this descriptive 
study is determined based on the rationale of adequately detecting relevant differences 
between immune responses: 
• 
Effect of the second vaccination in IC patients (within-participant comparison) 
In IC patients receiving 2 doses of RSV vaccine, this is evaluated by comparing the 
response post-Dose 2 (Visit 4) and post-Dose 1(Visit 3). The power and fold-increase that 
can be detected with a sample size of 100 evaluable participants are shown in Table 21 
below. 
Table 21 
Estimate of the fold-increase that can be detected by power 
SD 
Power 
Fold-increase 
0.5 
80% 
1.39 
0.5 
90% 
1.46 
0.4 
80% 
1.30 
0.4 
90% 
1.35 
Paired T-test: alpha (1-sided) = 2.5%, SD of differences = 0.5 (based on RSV OA=ADJ-002 data, 120 ug/AS01E 
group, V3 vs V6, SD difference neutra RSV-A = 0.23, SD difference neutra RSV-B = 0.40 inflated from 0.4 to 0.5 
to account for IC condition). 
• 
Difference in the humoral immune response of IC patients (1 and 2 doses) vs 
healthy participants (1 dose) 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
92 
One hundred evaluable participants in each group achieve 80% power to detect actual 
GMT fold differences of ≥1.55 at 1-sided α = 2.5% and 1:1 allocation ratio, assuming 
standard deviation of antibody log10-titers of 0.45 and 0.50 in the healthy and IC groups 
respectively (Two-sample T-test). 
In addition, pooling of IC groups after 1 dose (200 evaluable participants) allows to 
detect actual GMT fold differences of ≥1.45 with 80% power compared to healthy 
participants (100 evaluable participants). Two-sample T-test allowing unequal variance: 
alpha (1-sided) = 2.5%, SD = 0.45 (healthy), 0.5 (IC). 
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1. 
Appendix 1: Regulatory, ethical, and study oversight 
considerations 
10.1.1. 
Regulatory and ethical considerations 
• 
This study will be conducted in accordance with the protocol and with the following: 
− 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and CIOMS international ethical guidelines 
− 
Applicable ICH GCP guidelines 
− 
Applicable laws and regulations 
• 
The protocol, protocol amendments, ICF, IB, and other relevant documents (e.g., 
advertisements) must be submitted to an IRB/IEC by the investigator and reviewed 
and approved by the IRB/IEC before the study is initiated. 
• 
Substantial amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study participants. 
• 
Protocols and any substantial amendments to the protocol will require health 
authority approval prior to initiation except for changes necessary to eliminate an 
immediate hazard to study participants. 
• 
The investigator will be responsible for the following, as applicable: 
− 
Providing written summaries of the status of the study to the IRB/IEC annually 
or more frequently in accordance with the requirements, policies, and 
procedures established by the IRB/IEC 
− 
Notifying the IRB/IEC of SAEs or other significant safety findings as required 
by IRB/IEC procedures 
− 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
93 
10.1.2. 
Financial disclosure 
• 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and 
accurate financial certification or disclosure statements to the appropriate regulatory 
authorities. Investigators are responsible for providing information on financial 
interests during the course of the study and for 1 year after completion of the study. 
10.1.3. 
Informed consent process 
• 
The investigator or the investigator’s representative will explain the nature of the 
study, including the risks and benefits, to the participants/participants’ 
parent(s)/LAR(s) and answer all questions regarding the study. 
• 
Potential participants/participant’s parent(s)/LAR(s) must be informed that their/their 
child’s participation is voluntary. They or their LAR(s) will be required to physically 
sign a statement of informed consent that meets the requirements of 21 CFR 50, local 
regulations, ICH guidelines, HIPAA requirements, privacy and data protection 
requirements, where applicable, and the IRB/IEC or study center. 
• 
The investigator must obtain assent from the minor participant in addition to the 
consent provided by the participants’ parent(s)/LAR(s) when a minor can assent to 
participate in a study. The investigator is also accountable for determining a minor's 
capacity to assent to participation in a research study according to the local laws and 
regulations. 
• 
In accordance with local laws and regulations, participants who become legally 
emancipated during the study, i.e., reach the legal age of consent, must be 
reconsented. 
• 
The medical record must include a statement that physical informed consent was 
obtained before the participant was enrolled in the study and the date the physical 
consent was obtained. The authorized person obtaining the informed consent must 
also sign the ICF. 
• 
Participants must be reconsented to the most current version of the ICF(s) during 
their participation in the study. 
• 
A physical copy of the ICF(s) must be provided to the participant/participant’s 
parent(s)/LAR(s). 
• 
The participant must provide consent by signing an ICF, which summarizes the 
study, includes a consent statement and provides documentation that the participant 
agrees to continue participating in the study. Participants who are rescreened are 
required to sign a new ICF. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
94 
• 
The ICF will contain a separate section that addresses the use of remaining 
mandatory samples for optional exploratory research. The investigator or authorized 
designee will explain to each participant the objectives of the exploratory research. 
Participants will be told that they are free to refuse to participate and may withdraw 
their consent at any time and for any reason during the storage period. 
• 
In case of unexpected pregnancy, participant must be informed that personal 
information such as date of birth, sex of the baby will be collected as part of safety 
follow-up. Consent for the baby may be obtained from the participant and/or their 
partner as per local regulations. 
10.1.4. 
Recruitment strategy 
• 
The study is planned to be conducted at sites in multiple countries. The recruitment 
plan will be defined by each participating site. Recruitment will be tracked using 
RTSM system. 
• 
The recruitment plan may be adapted based on the actual number of participants 
enrolled in each country. In case a site would fall behind in participant recruitment, a 
redistribution of the enrollment target per site in the participating countries may be 
made. This would allow the other participating sites to enroll additional participants 
to ensure full and timely enrollment of the overall targeted number of participants 
specified in this protocol. 
• 
When the target number of participants is reached in a particular group (renal Tx, 
lung Tx or healthy) or age category (healthy), further enrollment of participants in 
that category will be stopped. If needed, the maximum number of participants in a 
particular disease or age category may be adapted during the study. 
• 
The procedures for participants identification/recruitment (e.g., referral letters, 
advertisements etc.) must be approved by the IRB/IEC together with the material 
intended for participants identification/recruitment and participants use. 
10.1.5. 
Data protection 
• 
Participants will be assigned a unique identifier by the investigator. Any participant 
records or datasets that are transferred to the sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred. 
• 
GSK will ensure protection of the personal data of the investigator and site staff 
which is collected within the framework of and for the purpose of the study. 
• 
The participant/participants’ parent(s)/LAR(s) must be informed that their/the minor 
participant’s personal study-related data will be used by the sponsor in accordance 
with local data protection law. The level of disclosure must also be explained to the 
participant/participants’ parent(s)/LAR(s), that their/the minor participant’s data will 
be used as described in the informed consent. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
95 
• 
The participant/participants’ parent(s)/LAR(s) must be informed that their/the minor 
participant’s medical records may be examined by Clinical Quality Assurance 
auditors or other authorized personnel appointed by the sponsor, by appropriate 
IRB/IEC members, and by inspectors from regulatory authorities. 
• 
The contract between sponsor and study sites specifies responsibilities of the parties 
related data protection, including handling of data security breaches and respective 
communication and cooperation of the parties. 
• 
Information technology systems used to collect, process, and store study-related data 
are secured by technical and organizational security measures designed to protect 
such data against accidental or unlawful loss, alteration, or unauthorized disclosure 
or access. GSK and/or trusted third parties working on behalf of GSK and/or 
institutions working with GSK for the purposes of this study are contractually bound 
to protect participant coded data. GSK will protect participant coded data and will 
only share it as described in the ICF. 
10.1.6. 
Committees structure 
• 
A SRT is in place for each GSK product. It comprises of a global cross-functional 
team responsible for the ongoing assessment of benefit-risk for a product. The SRT 
contribute to the continual assessment of incoming new efficacy and safety 
information. 
• 
Review and evaluation of safety data will be performed by an IDMC on a regular 
basis. Clinical experts on renal and lung transplantation will be included in the 
IDMC quorum. In preparation of the IDMC meetings, safety data will be 
summarized according to the IDMC charter. Only the outcomes and 
recommendations of the IDMC will be communicated to the study team. Operational 
details will be provided in the IDMC charter. 
10.1.7. 
Dissemination of Clinical Study Data 
• 
The key design elements of this protocol and results summaries will be posted on 
www.ClinicalTrials.gov and/or GSK Clinical Study Register in compliance with 
applicable regulations/GSK policy. GSK will aim to register protocols summaries 
prior to study start and target results summaries submission within 12 months of 
primary/ study completion date. Where external regulations require earlier 
disclosure, GSK will follow those timelines. 
• 
Where required by regulation, summaries will also be posted on applicable national 
or regional clinical study registers. 
• 
Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the study report, and provided reasonable access to 
statistical tables, figures, and relevant reports. GSK will also provide the investigator 
with the full summary of the study results, including a summary of trial results 
understandable to laypersons. The investigator is encouraged to share the plain 
language summary with the study participants, as appropriate. The full study report 
will be made available upon request, after decision on marketing authorization by 
regulatory authorities. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
96 
• 
GSK will provide the investigator with the randomization codes and participant-level 
line listings for their site only after completion of the full statistical analysis. 
• 
GSK intends to make anonymized participant-level data from this study available to 
external researchers for scientific analyses or to conduct further research that can 
help advance medical science or improve patient care. This helps ensure the data 
provided by study participants are used to maximum effect in the creation of 
knowledge and understanding. 
10.1.8. 
Data quality assurance 
• 
All participant data relating to the study will be recorded on printed or electronic 
CRFs unless transmitted to the sponsor or designee electronically (e.g., laboratory 
data). The investigator is responsible for verifying that data entries are accurate and 
correct by physically or electronically signing the CRF. 
• 
Guidance on completion of eCRFs will be provided in eCRF completion guidelines. 
• 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source documents. 
• 
QTLs will be predefined in the Quality plan to identify systematic issues that can 
impact participant right, safety and/or reliability of study results. These predefined 
parameters will be monitored during the study, and important deviations from the 
QTLs and remedial actions taken will be summarized in the CSR. 
• 
Monitoring details describing strategy, including definition of study critical data 
items and processes (e.g., risk-based initiatives in operations and quality such as risk 
management and mitigation strategies and analytical risk-based monitoring, 
involvement of central reading mechanism) methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring 
techniques (central, remote, or on-site monitoring) are provided in the monitoring 
plan. 
• 
The sponsor or designee is responsible for the data management of this study, 
including quality checking of the data. 
• 
The sponsor assumes accountability for actions delegated to other individuals (e.g., 
contract research organizations). 
• 
Records and documents, including signed ICF, pertaining to the conduct of this study 
must be retained by the investigator for 25 years from the issue of the final CSR/ 
equivalent summary unless local regulations or institutional policies require a 
different retention period. No records may be destroyed during the retention period 
without the written approval of the sponsor. No records may be transferred to 
another location or party without written notification to the sponsor. 
• 
When copies of source documents are shared externally for review by a central 
reader mechanism (e.g., endpoint adjudication committee; expert reader), documents 
are stored by the external body for 25 years. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
97 
10.1.9. 
Source documents 
• 
Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site. 
• 
Data reported on the eCRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must 
be explained. The investigator may need to request previous medical records or 
transfer records, depending on the study. Also, current medical records must be 
available. 
• 
Definition of what constitutes source data and its origin can be found in Definition of 
Terms. 
• 
The investigator must maintain accurate documentation (source data) that supports 
the information entered in the eCRF. 
• 
The sponsor or designee will perform monitoring to confirm that data entered into 
the eCRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and 
that the study is being conducted in accordance with the currently approved protocol 
and any other study agreements, ICH GCP, and all applicable regulatory 
requirements. 
• 
Copies of documents are shared with external third parties contracted by GSK for 
review by a central reader mechanism (e.g., endpoint adjudication committee; expert 
reader). The non-exhaustive list of documents shared to inform the central reader 
may include, discharge summaries, imaging reports, ECG reports etc. Participant 
names or any information which would make the participant identifiable or is not 
essential for the central reader mechanism will be redacted by the investigator sites 
prior to transfer. Details of the list of documents and the redaction procedure are 
provided in the site manual or equivalent. These documents will be used by the third 
party solely for the purpose indicated within this protocol. 
10.1.10. 
Study and site start and closure 
Start of study and first act of recruitment 
The start of study and the first act of recruitment are defined as FSFV (first ICF signature 
date). 
Study/site termination 
GSK or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of GSK. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study site closure visit has been performed. 
The investigator may initiate study site closure at any time, provided there is reasonable 
cause and sufficient notice is given in advance of the intended termination. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
98 
Reasons for the early closure of a study site by the sponsor or investigator may include 
but are not limited to: 
• 
For study termination: 
− 
Discontinuation of further study intervention development 
• 
For site termination: 
− 
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor’s procedures, or GCP guidelines 
− 
Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
participants by the investigator 
− 
Total number of participants included earlier than expected in the study 
If the study is prematurely terminated or temporarily suspended, the sponsor shall 
promptly inform the investigators, the IECs/IRBs, the regulatory authorities, and any 
contract research organization(s) used in the study of the reason for termination or 
temporary suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participant and should assure appropriate 
participant therapy and/or follow-up. 
10.1.11. 
Publication policy 
The results of this study may be published in peer reviewed scientific literature and/or 
presented at scientific meetings. The sponsor will comply with the requirements for 
publication of study results in accordance with standard editorial and ethical practice and 
as per the sponsor’s internal policy. Authorship will be determined by mutual agreement 
and in line with ICMJE authorship requirements. 
10.2. 
Appendix 2: Clinical laboratory tests 
10.2.1. 
RSV-A and RSV-B neutralization assays 
The serum neutralization assay is a functional assay that measures the ability of serum 
antibodies to neutralize RSV entry and replication in a host cell line. 
Virus neutralization is performed by incubating a fixed amount of RSV-A strain (Long, 
ATCC No. VR-26) or RSV-B strain (18537, ATCC No. VR-1580) with serial dilutions of 
the test serum. The serum-virus mixture is then transferred onto a layer of Vero cells 
(African Green Monkey, kidney, Cercopitheus aethiops, ATCC CCL 81) and incubated 
for 2 days to allow infection of the Vero cells by non-neutralized virus and the formation 
of plaques in the cell layer. Following a fixation step, RSV-infected cells are detected 
using a primary antibody directed against RSV (Polyclonal anti-RSV-A/B IgG) and a 
secondary antibody conjugated to horse-radish peroxidase, allowing the visualization of 
plaques after coloration with TrueBlue peroxidase substrate. Viral plaques are counted 
using an automated microscope coupled to an image analyzer (Scanlab system with a 
Reading software or equivalent). For each serum dilution, a ratio, expressed as a 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
99 
percentage, is calculated between the number of plaques at each serum dilution and the 
number of plaques in the virus control wells (no serum added). The serum neutralizing 
titer is expressed in Estimated Dilution 60 and corresponds to the inverse of the 
interpolated serum dilution that yields a 60% reduction in the number of plaques 
compared to the virus control wells, as described by others [Barbas, 1992; Bates, 
2014]. Secondary standards calibrated against the international reference (NIBSC 16/284) 
[McDonald, 2018; McDonald, 2020] are included in every run to allow conversion into 
international units per milliliter. 
10.2.2. 
Intracellular cytokine staining 
The ICS is used to assess RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at 
least 2 activation markers including at least 1 cytokine among CD40L, 4-1BB, IL-2, 
TNF-α, IFN-γ, IL-13, IL-17 (secondary endpoint). 
As previously described [Moris, 2011], thawed PBMCs are stimulated in vitro in the 
presence of anti-CD28 and anti-CD49d antibodies either with pools of 15-mer peptides 
overlapping by 11 amino acids and spanning the sequence of the RSVPreF3 protein, or 
with medium. After 2 hours of incubation at 37oC, Brefeldin A is added to inhibit 
cytokine secretion during an additional overnight incubation at 37oC. Cells are 
subsequently harvested, stained for surface markers (CD4+ and CD8+) and then fixed. 
Fixed cells are then permeabilized and stained with labeled antibodies specific for the 
following immune markers: 
• 
CD3+: phenotyping T cells; 
• 
CD40L (CD154), expressed on activated CD4+ T cells, [Chattopadhyay, 2005; 
Frentsch, 2005; Samten, 2000; Stubbe, 2006]; 
• 
IL-2: key for the development, survival and function of T cells [Boyman, 2012]; 
• 
TNF-α: anti-viral/intracellular factor, pro-inflammatory cytokine, cytotoxicity 
[Sedger, 2014]; 
• 
IFN-γ: anti-viral factor, associated with the Th1-like profile [Schoenborn, 2007]; 
• 
4-1BB (CD137), expressed on activated CD4+ and CD8+ T cells [Wölfl, 2008]; 
• 
IL-13: associated with the Th2-like profile [Bao, 2015]; 
• 
IL-17: associated with the Th17-like profile [Korn, 2009]. 
After staining with the markers above, the cellular samples are analyzed by 
flow-cytometry allowing to determine the frequency of CD4+ and/or CD8+ T cells 
expressing the marker(s) of interest per million of total CD4+ and/or CD8+ T cells. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
100 
10.3. 
Appendix 3: AEs and SAEs: Definitions and procedures for 
recording, evaluating, follow-up, and reporting 
10.3.1. 
Definition of AE 
AE definition 
• 
An AE is any untoward medical occurrence in a clinical study participant, 
temporally associated with the use of a study intervention, whether or not 
considered related to the study intervention. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of a study intervention. 
Events Meeting the AE Definition 
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or 
urinalysis) or other safety assessments (e.g., ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator (i.e., not 
related to progression of underlying disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New condition detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected intervention- intervention 
interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae. 
• 
Events that occur as a result of protocol-mandated procedures (i.e., invasive 
procedures, modification of participant’s previous therapeutic regimen). 
Events NOT Meeting the AE Definition  
• 
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
• 
Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital, admission for routine examination.). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
101 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen. Pre-existing 
diseases will be recorded in the medical history section of the eCRF. 
• 
Hospitalization for elective treatment of a pre-existing condition (known or 
diagnosed before signing the informed consent) that did not worsen from baseline. 
10.3.2. 
Definition of SAE 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or 
more of the criteria listed: 
• 
Results in death 
• 
Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which 
the participant was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe. 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization 
− 
In general, hospitalization signifies that the participant has been admitted 
(usually involving at least an overnight stay) at the hospital or emergency 
ward for observation and/or treatment that would not have been appropriate in 
the physician’s office or outpatient setting. Complications that occur during 
hospitalization are AE. If a complication prolongs hospitalization or fulfills 
any other serious criteria, the event is serious. When in doubt as to whether 
“hospitalization” occurred or was necessary, the AE should be considered 
serious. 
− 
Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
• 
Results in persistent or significant disability/incapacity 
− 
The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. 
− 
This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g., sprained ankle) that may 
interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
• 
Is a congenital anomaly/birth defect in the offspring of a study participant 
• 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
102 
• 
Is a suspected transmission of any infectious agent via an authorized medicinal 
product 
• 
Other situations: 
− 
Possible Hy’s Law case: ALT ≥ 3x ULN AND total bilirubin ≥ 2x ULN 
(>35% direct bilirubin) or INR >1.5 must be reported as SAE 
− 
Medical or scientific judgment should be exercised by the investigator in 
deciding whether SAE reporting is appropriate in other situations such as 
significant medical events that may jeopardize the participant or may require 
medical or surgical intervention to prevent one of the other outcomes listed in 
the above definition. These events should usually be considered serious. 
Examples of such events include invasive or malignant cancers, intensive treatment for 
allergic bronchospasm, blood dyscrasias, convulsions, or development of intervention 
dependency or intervention abuse. 
10.3.3. 
Solicited events 
• 
Definition of solicited event 
Solicited events are predefined events (administration site events and systemic events) 
for which the participant/participant’s parent(s)/LAR(s) is specifically questioned, and 
which are noted by the participant/participant’s parent(s)/LAR(s) in their diary. 
Table 22 
Solicited administration site events 
Pain at administration site 
Redness at administration site 
Swelling at administration site 
Table 23 
Solicited systemic events 
Fever 
Myalgia (muscle pain) 
Arthralgia (joint pain) 
Headache 
Fatigue (tiredness) 
Note: Participants/participants’ parent(s)/LAR(s) will be instructed to measure and 
record the oral/axillary temperature in the evening, using a sponsor provided device. If 
additional temperature measurements are taken at other times of the day, 
participants/participants’ parent(s)/LAR(s) will be instructed to record the highest 
temperature in the diary card. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
103 
10.3.4. 
Unsolicited AE 
• 
Definition of unsolicited AE 
An unsolicited AE is an AE that was either not included in the list of solicited events or 
could be included in the list of solicited events but with an onset outside the specified 
period of follow-up for solicited events. Unsolicited AEs must have been 
communicated by participants/participant’s parent(s)/LAR(s) who has signed the 
informed consent. Unsolicited AEs include both serious and nonserious AEs. 
• 
Potential unsolicited AEs may be medically attended (i.e., symptoms or illnesses 
requiring a hospitalization, emergency room visit, or visit to/by a healthcare 
provider). The participants/participant’s parent(s)/LAR(s) will be instructed to 
contact the site as soon as possible to report medically attended event(s), as well as 
any events that, though not medically attended, are of participant’s/participant’s 
parent(s)/LAR(s) concern. Detailed information about reported unsolicited AEs 
will be collected by qualified site personnel and documented in the participant’s 
records. 
• 
Unsolicited AEs that are not medically attended nor perceived as a concern by the 
participant/participant’s parent(s)/LAR(s) will be collected during an interview 
with the participant/participant’s parent(s)/LAR(s) and by review of available 
medical records at the next visit. 
10.3.5. 
Recording, assessment and follow-up of AE, SAE, AESIs and 
pregnancies 
10.3.5.1. 
AE and SAE recording 
• 
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (e.g., hospital progress notes, laboratory reports, and diagnostics 
reports) related to the event. 
• 
The investigator will then record all relevant AE/SAE information. 
• 
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to GSK in lieu of completion of the eCRF/required form. 
• 
There may be instances when copies of medical records for certain cases are 
requested by GSK. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to GSK. 
• 
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE. 
• 
A pDiary will be used in this study to capture solicited administration site or 
systemic events. The pDiary will be distributed to all participants at Visit 1. The 
participant should be trained on how and when to complete the pDiary. If a 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
104 
participant is unable or not willing to complete the pDiary him/herself, he/she may 
be helped by a caregiver (refer to Definition of Terms for the definition of caregiver). 
• 
Anyone who measures administration site or systemic events and who will record the 
event in the pDiary, e.g., the study caregiver, should have received a caregiver 
information letter explaining the role of the caregiver prior to completing the pDiary. 
This training must be documented in the participant’s source record. 
• 
For each solicited and unsolicited AE the participant experiences, the 
participant/participant’s parent(s)/LAR(s) will be asked if they/the minor participant 
received medical attention (defined as unscheduled visit to or from medical 
personnel for any reason, including emergency room visits). This information will be 
recorded in the participant’s pDiary or in the participant’s diary (for solicited AEs) 
and in the participant’s eCRF as part of normal AE reporting (for unsolicited AEs). 
Medical attention received for SAEs/AESIs will have to be reported using the 
normal AE reporting process in the eCRF. 
• 
If any individual other than the participant/participant’s parent(s)/LAR(s) is making 
entries in the pDiary, their identity must be documented in the participant’s source 
record. 
• 
Note: pDiary may be completed by a minor participant under the supervision of the 
participant’s parent(s)/LAR(s) provided the minor is capable of assessing and 
reporting the information to be recorded on pDiary. The ultimate accountability for 
completion of the pDiary remains with the participant’s parent(s)/LAR(s). The 
investigator should discuss this accountability with the participant’s 
parent(s)/LAR(s). 
• 
The investigator or delegate should verify the reported information during a 
discussion with the minor participant preferably in the presence of their 
parent(s)/LAR(s). 
• 
Collect and verify completed pDiary during discussions with the participant on 
Visit 3 (all groups) and 4 (IC 2-dose group), respectively. 
• 
Any unreturned pDiary will be sought from the participant/participant’s 
parent(s)/LAR(s) through telephone call(s) or any other convenient procedure. 
• 
The investigator or delegate will transcribe the required information into the eCRF in 
English. 
10.3.5.2. 
Assessment of intensity 
The investigator will make an assessment of intensity for each AE, AESI and SAE 
reported during the study and assign it to one of the following categories: 
• 
Mild: 
A type of AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual activities 
of daily living. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
105 
• 
Moderate:  
A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the research 
participant. 
• 
Severe:  
A type of AE that interrupts usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. 
• 
The intensity of the following solicited AEs will be assessed as described: 
Table 24 
Intensity scales for solicited events in participants ≥18 YoA (IC 
group) and ≥50 YoA (HA group) 
Event 
Intensity grade 
Parameter 
Pain at administration site 
0 
None 
1 
Mild: Any pain neither interfering with nor preventing normal 
everyday activities 
2 
Moderate: Painful when limb is moved and interferes with 
everyday activities 
3 
Severe: Significant pain at rest. Prevents normal everyday 
activities 
Redness at administration site 
See Table 25 
Greatest surface diameter in mm 
Swelling at administration site 
See Table 25 
Greatest surface diameter in mm 
Temperature* 
See Table 25 
Temperature in °C/°F 
Headache 
0 
None** 
1 
Mild: Headache that is easily tolerated 
2 
Moderate: Headache that interferes with normal activity 
3 
Severe: Headache that prevents normal activity 
Fatigue (tiredness) 
0 
None** 
1 
Mild: Fatigue that is easily tolerated 
2 
Moderate: Fatigue that interferes with normal activity 
3 
Severe: Fatigue that prevents normal activity 
Myalgia (muscle pain) 
0 
None** 
1 
Mild: Myalgia present but does not interfere with activity 
2 
Moderate: Myalgia that interferes with normal activity 
3 
Severe: Myalgia that prevents normal activity 
Arthralgia (joint pain) 
0 
None** 
1 
Mild: Arthralgia present but does not interfere with activity 
2 
Moderate: Arthralgia that interferes with normal activity 
3 
Severe: Arthralgia that prevents normal activity 
* Refer to the SoA (Section 1.3) for the definition of fever and the preferred location for temperature measurement. 
**For participants already experiencing some of the solicited systemic events, ‘None’ corresponds to ‘similar to 
baseline’ and only discomfort above baseline is to be reported as ≥1. 
The maximum intensity of administration site redness/swelling, and fever will be scored 
at GSK as follows: 
Table 25 
Intensity scales of administration site redness/swelling, and fever 
Intensity 
grade 
Redness/Swelling 
Fever 
0 
≤20 mm 
<38.0°C (100.4°F) 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
106 
1 
>20 - ≤50 mm 
≥38.0°C (100.4°F) - ≤38.5°C (101.3°F) 
2 
>50 - ≤100 mm 
>38.5°C (101.3°F) - ≤39.0°C (102.2°F) 
3 
>100 mm 
>39.0°C (102.2°F) 
The investigator will assess the maximum intensity that occurred over the duration of the 
event for all unsolicited AEs (including SAEs) recorded during the study. The assessment 
will be based on the investigator’s clinical judgment. 
An AE that is assessed as Grade 3 (severe) should not be confused with an SAE. Grade 3 
is a category used for rating the intensity of an event; and both AEs and SAEs can be 
assessed as Grade 3. An event is defined as ‘serious’ when it meets 1 of the predefined 
outcomes as described in the Section 10.3.2. 
10.3.5.3. 
Assessment of causality 
• 
The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE. The investigator will use clinical judgment to 
determine the relationship. 
• 
A reasonable possibility of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated. 
• 
For causality assessment, the investigator will also consult the IB and/or product 
information, for marketed products. 
• 
The investigator must review and provide an assessment of causality for each 
AE/SAE and document this in the medical notes There may be situations in which an 
SAE has occurred and the investigator has minimal information to include in the 
initial report to GSK. However, it is very important that the investigator always make 
an assessment of causality for every event before the initial transmission of the SAE 
data to GSK. 
• 
The investigator may change their opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
107 
10.3.5.4. 
Assessment of outcomes 
The investigator will assess the outcome of all serious and nonserious unsolicited AEs 
recorded during the study as: 
• 
Recovered/resolved 
• 
Recovering/resolving 
• 
Not recovered/not resolved 
• 
Recovered with sequelae/resolved with sequelae 
• 
Fatal (SAEs only). 
10.3.5.5. 
Follow-up of AEs, SAEs, AESIs and pregnancies 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by GSK to 
elucidate the nature and/or causality of the AE or SAE as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, 
or consultation with other health care professionals. 
• 
New or updated information will be recorded in the originally submitted documents. 
• 
The investigator will submit any updated SAE data to GSK within 24 hours of 
receipt of the information. 
• 
After the initial AE/SAE/AESI/pregnancy or any other event of interest, the 
investigator is required to proactively follow each participant at subsequent 
visits/contacts. All SAEs will be followed until the event is resolved, stabilized, 
otherwise explained, or the participant is lost to follow-up. 
• 
Other nonserious AEs must be followed until end of study or until the participant is 
lost to follow-up. 
Follow-up during the study 
AEs/AESIs documented at a previous visit/contact and defined as not recovered/not 
resolved or recovering/resolving will be reviewed at subsequent visits/contacts until end 
of study. 
If a participant dies during their participation in the study or during a recognized follow-
up period, GSK will be provided with any available postmortem findings, including 
histopathology. 
Follow-up of pregnancies 
Pregnant participants will be followed to determine the outcome of the pregnancy. At the 
end of the pregnancy, whether full-term or premature, information on the status of the 
mother and child will be forwarded to GSK using the electronic pregnancy report and the 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
108 
AE Report if applicable. Generally, the follow-up period does not need to be longer than 
6 to 8 weeks after the estimated date of delivery. 
Regardless of the reporting period for SAEs in this study, if the pregnancy outcome is an 
SAE, it should always be reported as such. 
Furthermore, the investigator must report any SAE occurring as a result of a post-study 
pregnancy that is considered by the investigator to be reasonably related to the study 
intervention, to GSK as described in the Section 10.3.5.7. 
10.3.5.6. 
Updating of SAE, AESI and pregnancy information after removal of 
write access to the participant’s eCRF 
When additional SAE, AESI or pregnancy information is received after write access to 
the participant’s eCRF is removed, new or updated information should be recorded on the 
appropriate paper report, with all changes signed and dated by the investigator. The 
updated report should be sent to the Study contact for reporting SAEs (refer to 
Section 8.4.7). 
10.3.5.7. 
Reporting of SAEs, AESIs and pregnancies 
SAE Reporting to GSK via an Electronic Data Collection Tool 
• 
The primary mechanism for reporting an SAE to GSK will be the electronic data 
collection tool. 
• 
If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to report the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as it becomes 
available. 
• 
After the study is completed at a given site, the electronic data collection tool will be 
taken offline to prevent the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken offline, then the site can report this information on a paper SAE form (see next 
section). 
• 
If the site during the course of the study or post-study becomes aware of any serious, 
nonserious AEs, pregnancy exposure, related to any GSK non-IMP they will report 
these events to GSK or to the concerned competent authority via the national 
spontaneous reporting system. These will be classified as spontaneous ICSRs. 
• 
Contacts for SAE reporting can be found in Section 8.4.7. 
SAE Reporting to GSK via Paper Data Collection Tool 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
109 
• 
Email/fax transmission of the SAE paper data collection tool is the preferred method 
to transmit this information. 
• 
In rare circumstances and in the absence of email/fax equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier service. 
• 
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE data collection tool within the designated reporting 
timeframes. 
• 
Contacts for SAE reporting can be found in Section 8.4.7. 
10.4. 
Appendix 4: Guidance on Contraception, Women not 
considered as WOCBP and collection of pregnancy 
information 
This section covers wording on the definition of what we consider to be a woman of 
childbearing potential as well as guidance on what is considered as adequate 
contraception. 
10.4.1. 
Definitions 
10.4.1.1. 
Woman of childbearing potential (WOCBP) 
A woman is considered WOCBP (fertile) from the time of menarche until becoming 
postmenopausal unless permanently sterile (see below). 
Note: Menarche is the first onset of menses in a young female. Menarche is normally 
preceded by several changes associated with puberty including breast development and 
pubic hair growth. 
10.4.1.2. 
Woman of Nonchildbearing potential (WONCBP) 
Women in the following categories are considered WONCBP: 
• 
Premenopausal female permanently sterile due to one of the following procedures: 
− 
Documented hysterectomy 
− 
Documented bilateral salpingectomy 
− 
Documented bilateral oophorectomy 
For permanently sterile individuals due to an alternate medical cause other than the 
above, (e.g., Mullerian agenesis, androgen insensitivity, gonadal dysgenesis), 
investigator discretion should be applied to determining study entry. If reproductive 
status is questionable, additional evaluation should be considered. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
110 
Note: Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview. 
• 
Postmenopausal female 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
• 
A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or HRT. 
However, in the absence of 12 months of amenorrhea, confirmation with more than 
one FSH measurement is required. 
• 
Females on HRT and whose menopausal status is in doubt must discontinue HRT to 
allow confirmation of postmenopausal status before study enrollment. 
10.4.2. 
Contraception guidance 
10.4.2.1. 
Woman of childbearing potential (WOCBP) 
Female participants of childbearing potential are eligible to participate if they agree to 
use a highly effective contraceptive method consistently and correctly according to the 
methods listed in GSK’s list of highly effective contraceptive methods (Table 26). 
Table 26 
Highly effective contraceptive methods 
Highly Effective Contraceptive Methods That Are User Dependent a 
Failure rate of <1% per year when used consistently and correctly 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation 
• 
Oralb 
• 
Intravaginal 
• 
Transdermal  
Progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Injectable 
• 
Oralb (only if allowed by local regulations or if part of standard medical practice in the country) 
Highly Effective Methods That Are User Independent  
• 
Implantable progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) 
• 
Bilateral tubal occlusion/ligation 
Vasectomized partner 
(A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual 
partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used.)  
Male partner sterilization prior to the female participant’s entry into the study, and this male is the sole partner for that 
participant, 
(The information on the male sterility can come from the site personnel’s review of the participant’s medical records; 
medical examination and/or semen analysis, or medical history interview provided by her or her partner) 
Sexual abstinence 
(Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse 
during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).  

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
111 
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with 
local regulations regarding the use of contraceptive methods for subjects in clinical studies. 
b For WOCBP taking hormonal contraception, an additional barrier contraception method is recommended if they are 
concomitantly taking drugs that interact and reduce effectiveness of hormonal contraception. The investigator 
should check the list of drugs that could reduce hormonal contraceptive effectiveness (Potent drug enzyme 
inducers). 
10.5. 
Appendix 5: Grading scales in scope of the SOT population 
10.5.1. 
Chronic kidney disease (CKD) classification in RTx patients 
Stages of CKD quantify the severity of the disease. CKD is classified into 5 stages 
[Levey, 2005]. 
• 
Stage 1: Normal GFR (≥90 mL/min/1.73 m2) plus either persistent albuminuria or 
known structural or hereditary renal disease 
• 
Stage 2: GFR 60 to 89 mL/min/1.73 m2 
• 
Stage 3: 30 to 59 mL/min/1.73 m2 
• 
Stage 4: GFR 15 to 29 mL/min/1.73 m2 
• 
Stage 5: GFR < 15 mL/min/1.73 m2 
GFR (in mL/min/1.73 m2) in CKD can be estimated by the CKD-EPI creatinine equation: 
141 × (serum creatinine) -1.209× 0.993 age. The result is multiplied by 1.018 if the 
patient is female, and by 1.159 if the patient is African American. For female African 
Americans, the result is multiplied by 1.018 × 1.159 (1.1799). Alternatively, GFR can be 
estimated using timed (most commonly 24 hours) urine creatinine clearance using 
measured serum and urine creatinine; this equation tends to overestimate GFR by 10 to 
20%. It is used when serum creatinine assessment may not be as accurate (e.g., in patients 
who are sedentary, very obese, or very thin). Serum cystatin C is an alternative 
endogenous GFR marker used as a confirmatory test in people with nonrenal factors 
affecting serum creatinine level (e.g., extremely high, or low muscle mass, exogenous 
creatine intake, amputations or neuromuscular diseases, and high protein or exclusively 
plant-based diets). GFR is calculated using CKD-EPI cystatin C equation. 
The CKD-EPI formula is more accurate than the MDRD and Cockcroft-Gault formulas, 
particularly for patients with a GFR near normal values. The CKD-EPI equation yields 
fewer falsely positive results indicating chronic kidney disease and predicts outcome 
better than the other formulas. 
10.5.1.1. 
Revised equations for eGFR from serum creatinine in Japan 
In Japanese population other equations might be used [Matsuo, 2009]. The literature 
reports that the new Japanese coefficient for the modified IDMS–MDRD Study equation 
and the new Japanese equation are more accurate for the Japanese population than the 
previously reported equations. If such equations are used to calculate eGFR they should 
be provided to the sponsor prior to the study start (see Section 8.1.7.1). 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
112 
IDMS–MDRD Study equation with new Japanese coefficient: 
• 
3-variable Japanese equation:  
eGFR = 194 x SCr-1.094 x Age-0.287 (x 0.739 if female) 
• 
5-variable Japanese equation:  
eGFR = 142 x SCr-0.923 x Age-0.185 x Alb0.414 x SUN-0.233 (x 0.772 if female) 
Alb = Albumin; eGFR = estimated glomerular filtration rate; IDMS = isotope dilution mass spectrometry; MDRD = 
Modification of Diet in Renal Disease; SCr = serum creatinine; SUN = serum urea nitrogen 
Although the 5-variable Japanese equation estimates GFR more accurately than other 
equations, SUN and albumin are not routinely measured in Japan. 
Because the new 3-variable Japanese equation provided reasonably accurate eGFRs, it 
was recommended to use the new 3-variable Japanese equation. 
10.5.2. 
Proteinuria/albuminuria categories in CKD in RTx patients 
Adapted from [Chapter 1: Definition and classification of CKD, 2013]. 
Table 27 
Proteinuria/albuminuria categories in CKD 
Category 
ACR (approximate equivalent) 
Terms 
 
mg/mmol 
mg/g 
 
A1 
<30 
<30 
Normal to mild increase 
A2 
30-300 
30-300 
Moderately increased * 
A3 
>300 
>300 
Severely increased** 
ACR = albumin-to-creatinine ratio 
Table 28 
Relationship among categories for albuminuria and proteinuria 
Measure 
Category 
Normal to mildly increased (A1) 
Moderately increased (A2) 
Severely increased (A3) 
ACR 
  mg/mmol 
<3 
3-30 
>30 
  mg/g 
<30 
30-300 
>300 
PCR 
  g/mmol 
<15 
15-50 
>50 
  mg/g 
<150 
150-500 
>500 
Protein reagent 
strip 
Negative to trace 
Trace to + 
+ or greater 
ACR = albumin-to-creatinine ratio; PCR = protein-to-creatinine ratio. 
Albuminuria and proteinuria can be measured using excretion rates in timed urine collections, ratio of 
concentrations to creatinine in spot urine samples, and using reagent strips in spot urine samples. 
The conversions are rounded for pragmatic reasons. (For an exact conversion from mg/g of creatinine to mg/mmol 
of creatinine, multiply by 0.113) Creatinine excretion varies with age, sex, race and diet; therefore, the 
relationship among these categories is approximate only. The relationship between urine reagent strip results 
and other measures depends on urine concentration. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
113 
10.5.3. 
Staging of bronchoscopy – acute cellular rejection (ACR) in LTx 
patients 
Classification of ACR is according to the 2007 Working Formulation of the International 
Society for Heart and Lung Transplantation (ISHLT) [Roden, 2017]. 
Table 29 
Classification of ACR 
Acute Rejection 
Small Airways Inflammation -Lymphocytic Bronchiolitis 
ISHLT Grade 
Definition 
ISHLT Grade 
Definition 
A0 
None 
B0 
None 
A1 
Minimal 
B1R 
Low grade 
A2 
Mild 
B2R 
High grade 
A3 
Moderate 
BX 
Ungradable 
A4 
Severe 
 
 
10.5.4. 
Grading of bronchoscopy – antibody-mediated rejection (AMR) in 
LTx patients 
Staging of Clinical AMR is as proposed by the 2016 ISHLT Consensus Report [Roden, 
2017]. 
Table 30 
Classification of AMR 
Criteria 
AMR Stage 
Definite 
Probable 
Possible 
Donor-specific antibodies 
+ 
2 of the 3 criteria 
are present 
1 of the 3 criteria is 
present 
Histology suggestive of AMR 
+ 
C4d deposition 
+ 
10.5.5. 
CLAD staging in LTx patients 
CLAD is classified into 5 stages. Once CLAD is diagnosed, staging is performed 
according to the decline in FEV1, compared with baseline. The date of onset of CLAD is 
defined as the date at which the first value of FEV1 ≤80% of baseline was recorded when 
subsequent values taken at least 3 weeks (and for definite CLAD up to 3 months) apart 
also fell below the threshold. The same principle holds for each stage [Verleden, 2019]. 
Table 31 
Stages of CLAD 
Stage  
Spirometry 
CLAD 0  
Current FEV1 >80% FEV1 compared to baseline 
CLAD 1  
Current FEV1 >65–80% FEV1 compared to baseline 
CLAD 2  
Current FEV1 >50–65% FEV1 compared to baseline 
CLAD 3  
Current FEV1 >35–50% FEV1 compared to baseline 
CLAD 4  
Current FEV1 ≤35% FEV1 compared to baseline 
10.6. 
Appendix 6: Country-specific requirements 
10.6.1. 
Germany 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
114 
Explanatory statement concerning Gender Distribution (Article 7, paragraph 2 (12) 
of the German GCP ORDER). 
For this study, there is no intention to conduct specific analyses investigating the 
relationship between gender and the safety, immunogenicity and efficacy of the 
investigational RSVPreF3 OA vaccine. Recruitment will include both males and females. 
To not expose pregnant women and their fetuses/children to an investigational vaccine, 
females enrolled in this study will either be of nonchildbearing potential (i.e., 
hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause), or if 
she is of childbearing potential, she must have a negative pregnancy test and use 
appropriate methods of contraception for the study duration (refer to the study protocol, 
Section 5.1 “Inclusion criteria” and Section 5.2 “Exclusion criteria”). Women who are 
pregnant, planning to become pregnant or breastfeeding are excluded from this study. 
Remote Source Data Verification during exceptional situations in Germany 
Frequent instream monitoring of safety data by the central study team at GSK is required 
for this study. Instream review of study data items and processes should be considered 
during exceptional situations/circumstances, such as with pandemics like COVID-19, 
focusing on key data points, patient assessments and processes that are critical to ensure 
the rights, safety and well-being of study participants and the integrity of the study and 
data. Prior to any rSDV activity a written agreement by the investigator will be obtained. 
The agreement includes the extent and the method of rSDV activities. Monitoring Plan 
and Study-Specific Risk Register will be updated to include rSDV activities and CRAs 
will be guided for the conduct of rSDV. 
Option 1 Transfer of redacted Source Documentation 
Process for transfer and review of redacted source documentation provided by the site: 
• 
The CRA instructs study site on the source data needed for the remote SDV 
activities. 
• 
The CRA instructs site staff they must pseudonymize the requested documentation, 
do a quality check that anonymized (redacted) areas cannot be read, and then 
delivers the documentation to the CRA in an encrypted form of communication (the 
site should have a documented process). 
• 
The minimum requirements regarding quality of the copies will be agreed with the 
site upfront: 
− 
For the scanning of paper documents resolution will be a minimum of 300 dpi. 
− 
For the scanning of photographs and images resolution will be 600 dpi 
minimum. 
− 
Color scanners must be able to produce copies that match the original. 
− 
A4 format as final size without loss of information. 
− 
Documents will be saved as PDF. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
115 
− 
In order to maintain quality standards, a captured image will not be subjected to 
non- uniform scaling (i.e., sizing) or re-sampling to a lower resolution. 
• 
Redacted source document scans will be sent to the CRA via email using 1 of the 
following secure options: 
− 
TLS connection: 
TLS connections are intended to support significant mail flow between GSK and 
external partners in a secure manner. 
− 
GSK Secure 
In cases where only a handful of users are communicating or the volume of emails is 
low, the use of GSK secure, the GSK ad-hoc message encryption solution is 
recommended. 
− 
Password protected PDF attachment 
A password protected scan (PDF) will be attached to an email. The password to open 
the attachment will be send in a separate email. 
• 
The CRA may use the secure email website to assess whether the sites email address 
is secure (i.e., encrypted). 
 
• 
Prior to starting remote SDV the CRA ensures that the provided documents are 
complete and does not contain any personal information. 
− 
In case the CRA detects any personal information that has not been redacted, the 
CRA informs the study site and deletes the files (incl. the Recycle bin). 
− 
A Data Breach must be reported Data Breach Web Report Form. 
• 
Use of an external PC screen is recommended. The CRA will not generate any 
copies from the source data received. 
• 
Source data verification/review will be conducted according to the process outlined 
in the GSK Monitoring SOP. 
• 
After completion of SDV activities, the CRA deletes all copies/images of participant 
data received from the site. This includes the deletion of the recycle bin and any 
temporary files. 
• 
A statement confirming that all documents were destroyed will be provided by the 
CRA via email to the site. 
• 
Details of what was monitored remotely will be documented in the appropriate 
section of the Monitoring Visit Report. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
116 
Option 2 – Review of Subject Source Documentation remotely 
Process for use of Webcams, WebEx, MS Teams for viewing participant source 
remotely: 
• 
The CRA ensures that the site personnel sharing information with GSK have 
authority to do so. 
• 
Remote SDV activities will be performed exclusively by the assigned site monitor. 
• 
Prior to conducting any remote SDV activities the CRA ensures that a written 
informed consent, covering the proposed SDV activities, has been signed by the 
study patient. 
• 
For CRAs using GSK laptops, only use GSK approved video conferencing tools 
(e.g., MS Teams or GSK WebEx). Live image transmission is fully encrypted and 
protected for authorized user. By using these systems, it will be assured that data will 
be viewed only but not transmitted/stored. 
• 
FSP/Local CRO CRAs not using GSK laptops, only MS Teams via Remote Access 
Application may be used for meetings between the CRA and the site. WebEx is not 
permitted from non-GSK laptops. Other tools like FaceTime, WhatsApp or Zoom are 
not permitted since they do not have sufficient encryption features. GSK does not 
have enterprise contract/privacy agreement with these providers. 
• 
Prior to the remote monitoring visit, the CRA instructs study site on the specific data 
needed for the remote SDV. 
• 
Source data verification will be conducted according to the process outlined in the 
Monitoring SOP. 
• 
The use of a headset is required, do not use computer audio. 
• 
The CRA does not capture screens or take pictures of screens to ensure we are not 
transferring content outside of clinical sites. 
• 
WebEx or Teams do not store or have access to any data, GSK staff is not allowed to 
make or store any screenshots or save any data which has been shared. 
• 
Details of what was monitored remotely will be documented in the appropriate 
section of the Monitoring Visit Report. 
• 
In case of technical malfunctions or if the security of the transmission is no longer 
ensured, we will pause rSDV activities. GSK Issue Management Procedures will be 
initiated. 
10.6.2. 
Japan 
Regulatory and ethical considerations 
The study will be conducted in accordance with “the Ministerial Ordinance on the 
Standards for the Conduct of Clinical Trials of Medicinal Products (MHW Notification 
No.28 dated 27 March 1997)” and Pharmaceuticals and Medical Devices Act. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
117 
The statement “To assume responsibility for the proper conduct of the study at this site.” 
on the Protocol Investigator Agreement Page means the investigator’s responsibility 
defined by Japanese GCP. 
GSK will submit the clinical trial notification to the regulatory authorities in accordance 
with Pharmaceuticals and Medical Devices Act before conclusion of any contract for the 
conduct of the study with study sites. 
Study period 
Study Period is included in Exhibit 1. 
Study administrative structure 
Sponsor information is included in Exhibit 1. List of Medical Institutions and 
Investigators is included in Exhibit 2. 
10.6.3. 
South Korea 
Exclusion criteria for enrollment of study participant 
As per local Regulation on Approval for Enforcement Regulation on the Safety of 
Pharmaceuticals, etc., Article 24 paragraph 2, a study participant cannot be enrolled in a 
trial if he or she has “participated as a subject in a clinical trial targeting healthy people 
within the last 6 months.” 
Therefore, in order to comply with this local requirement, investigators from Republic of 
Korea should carefully check, before enrolling each participant in the study, that they 
have not participated in any other clinical study targeting healthy people within the last 
6 months prior to enrollment/first study intervention administration (Refer Section 5.2.3). 
Participants from South Korea are required to be aged at least 19 years or greater for 
entry into the study. 
10.7. 
Appendix 7: Protocol amendment history 
The Protocol Amendment Summary of Changes Table for the current amendment is 
located directly before the TOC. 
Amendment 1 GER, ITA, SPN-1 
This amendment is considered substantial based on the criteria defined in EU Clinical 
Trial Regulation No 536/2014 of the European Parliament and the Council of the 
European Union because it significantly impacts the scientific value of the study. 
Overall rationale for the Amendment: 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
118 
Amendment 1 GER, ITA, SPN-1 is a country-specific protocol amendment created in 
response to Health Authority feedback to provide clarifications to the protocol, including 
those that impact participant enrollment and site conduct. A description and rationale for 
all changes is provided in the table below. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
119 
List of main changes in the protocol and their rationale: 
Section # and title 
Description of change 
Brief rationale 
Definition of terms 
 
Added the definitions for 
Serious Adverse Reaction 
(SAR) and Suspected 
Unexpected Serious Adverse 
Reactions (SUSAR). 
Response to health authority 
feedback to implement AE 
definitions according to EU-
CTR. 
2.1 Study rationale 
2.2 Background 
2.3 Benefit/risk 
assessment 
Added market approval 
information for RSV OA vaccine 
across countries. 
Response to health authority 
feedback to provide information 
on market authorization of the 
study vaccine. 
4.3 Justification for dose 
Revised the section to indicate 
that an approved formulation of 
the vaccine will be used in the 
study. 
Conistency with market 
authorization of the study 
vaccine, as requested by health 
authority. 
5.1.1 Inclusion criteria for 
all participants 
Revised inclusion criteria for 
informed consent to specify that 
participant must be able to 
understand the informed 
consent. 
Response to health authority 
feedback. 
5.2.1 Medical conditions 
Note added as a clarification for 
investigator’s assessment of 
potential hypersensitivity of 
participant to vaccine 
components. 
Response to health authority 
feedback to indicate Vaccine 
components that may ease 
investigator asessment for 
potential hypersensitivity 
reactions. 
6.9 Prior and concomitant 
therapy 
Text and table pertaining to 
prohibited medication and their 
washout period prior to 
vaccination has been added. 
Response to health authority 
feedback. 
8.3.4 Safety monitoring 
and committee 
Modified/deleted text to imply 
that SOT patients are defined 
as ‘special’ but not ‘vulnerable’ 
population. 
Response to health authority 
feedback that SOT patients 
cannot be defined as a 
‘vulnerable population’. 
8.4 Adverse events (AEs), 
serious adverse events 
(SAEs), and other safety 
reporting 
Added text pertaining to SUSAR 
reporting as per local 
authorities. 
Response to health authority 
feedback to add that SUSARs 
will be reported to 
Eudravigilance database. 
9.3.1 Primary 
endpoints/estimands 
analyses 
Added text to imply that missing 
data will not be imputed. 
 
Response to health authority 
feedback to add strategy for 
handling missing data. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
120 
Section # and title 
Description of change 
Brief rationale 
Throughout protocol 
Administrative and editorial 
changes were made to update 
sponsor signatory on cover 
page, align table numbers, 
formatting, and 
crossreferences. 
To maintain consistency with 
template guidance. 
 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
121 
11. 
REFERENCES 
Arexvy Prescribing Information. AREXVY (Respiratory Syncytial Virus Vaccine, 
Adjuvanted) suspension for intramuscular injection, 2023. Accessed in October 2023 at 
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy
/pdf/AREXVY.PDF 
Arexvy Summary of Product Characteristics. Arexvy powder and suspension for 
suspension for injection, Respiratory Syncytial Virus (RSV) vaccine (recombinant, 
adjuvanted), 2023. Accessed in October 2023 at 
https://www.ema.europa.eu/en/documents/overview/arexvy-epar-medicine-
overview_en.pdf 
Bao K, Reinhardt RL. The differential expression of IL-4 and IL-13 and its impact on 
type-2 immunity. Cytokine. 2015;75(1):25-37. doi: 10.1016/j.cyto.2015.05.008. 
Barbas CF, Crowe JE, Cababa D, et al. Human monoclonal Fab fragments derived from a 
combinatorial library bind to respiratory syncytial virus F glycoprotein and neutralize 
infectivity. Proc Natl Acad Sci USA. 1992;89(21):10164-8. 
Bates JT, Keefer CJ, Slaughter JC, et al. Escape from neutralization by the respiratory 
syncytial virus-specific neutralizing monoclonal antibody palivizumab is driven by 
changes in on-rate of binding to the fusion protein. Virology. 2014;454-455:139-44. 
doi: 10.1016/j.virol.2014.02.010. 
Borchers AT, Chang C, Gershwin ME, Gershwin LJ. Respiratory syncytial virus--a 
comprehensive review. Clin Rev Allergy Immunol. 2013;45(3):331-379. 
Boyman O, Sprent J. The role of interleukin-2 during homeostasis and activation of the 
immune system. Nat Rev Immunol. 2012;12(3):180-90. 
Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013;3(1):19-
62. doi:10.1038/kisup.2012.64 
Chattopadhyay PK, Yu J, Roederer M. A live-cell assay to detect antigen-specific CD4+ 
T cells with diverse cytokine profiles. Nat Med. 2005;11(10):1113-7. 
Clopper C.J., Pearson E., The Use of Confidence or Fiducial Limits Illustrated in the case 
of the Binomial. Biometrika. 1934; 26: 404-13. 
Dropulic LK, Lederman HM. Overview of Infections in the Immunocompromised Host. 
Microbiol Spectr. 2016;4(4). 
Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 
1998;338(24):1741-1751. 
Frentsch M, Arbach O, Kirchhoff D, et al. Direct access to CD4+ T cells specific for 
defined antigens according to CD154 expression. Nat Med. 2005;11(10):1118-24. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
122 
Haralambieva IH, Ovsyannikova IG, Pankratz VS, et al. The genetic basis for 
interindividual immune response variation to measles vaccine: new understanding and 
new vaccine approaches. Expert Rev Vaccines. 2013;12(1):57–70. 
Kollmann TR. Variation between populations in the innate immune response to vaccine 
adjuvants. Front Immunol. 2013;4:81. doi: 10.3389/fimmu.2013.00081. 
Korn T, Bettelli E, Oukka M, et al. IL-17 and Th17 Cells. Annu Rev Immunol. 
2009;27:485-517. 
Levey AS, Eckardt KU, Tsukamoto Y, et al. Definition and classification of chronic 
kidney disease: a position statement from Kidney Disease: Improving Global Outcomes 
(KDIGO). Kidney Int. 2005;67(6):2089-100. doi:10.1111/j.1523-1755.2005.00365.x 
Matsuo S, Imai E, Horio M, et al. Revised equations for estimated GFR from serum 
creatinine in Japan. Am J Kidney Dis. 2009;53(6):982-92. doi:10.1053/j.ajkd.2008.12.034 
McDonald JU, Rigsby P, Dougall T, et al. Establishment of the first WHO International 
Standard for antiserum to Respiratory Syncytical Virus: Report of an International 
collaborative study. Vaccine. 2018;36(50):7641-7649. doi: 
10.1016/j.vaccine.2018.10.087. 
McDonald JU, Rigsby P, Dougall T, et al. Expansion of the 1st WHO international 
standard for antiserum to respiratory syncytial virus to include neutralisation titres against 
RSV subtype B: An international collaborative study. Vaccine. 2020;38(4):800-807. doi: 
10.1016/j.vaccine.2019.10.095. 
Moris P, Van Der Most R, Leroux-Roels I, et al. H5N1 influenza vaccine formulated with 
AS03 A induces strong cross-reactive and polyfunctional CD4 T-cell responses. J Clin 
Immunol. 2011; 31(3):443-54. 
Neemann K, Freifeld A. Respiratory Syncytial Virus in hematopoietic stem cell 
transplantation and solid-organ transplantation. Curr Infect Dis Rep. 2015; 17(7):490. 
doi:10.1007/s11908-015-0490-9 
Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein 
Vaccine in Older Adults. N Engl J Med. 2023;388(7):595-608. 
doi:10.1056/NEJMoa2209604 
Pérez-Losada M, Posada D, Arenas M, et al. Ethnic differences in the adaptation rate of 
HIV gp120 from a vaccine trial. Retrovirology. 2009;6:67. 
Pochon C, Voigt S. Respiratory Virus Infections in Hematopoietic Cell Transplant 
Recipients. Front Microbiol. 2019;9:3294. 
Reichenberger F, Dickenmann M, Binet I, et al. Diagnostic yield of bronchoalveolar 
lavage following renal transplantation. Transpl Infect Dis. 2001;3(1):2-7. 

CONFIDENTIAL 
219900 (RSV OA=ADJ-023) 
Protocol Amendment 2 Final 
11 Oct 2023 
123 
Roden AC, Aisner DL, Allen TC, et al. Diagnosis of Acute Cellular Rejection and 
Antibody-Mediated Rejection on Lung Transplant Biopsies: A Perspective From 
Members of the Pulmonary Pathology Society. Arch Pathol Lab Med. 2017;141(3):437-
44. doi:10.5858/arpa.2016-0459-SA 
Samten B, Thomas EK, Gong J, Barnes PF. Depressed CD40 ligand expression 
contributes to reduced gamma interferon production in human tuberculosis. Infect Immun. 
2000;68(5):3002-6. 
Schoenborn JR, Wilson CB. Regulation of interferon-gamma during innate and adaptive 
immune responses. Adv Immunol. 2007;96:41-101. 
Sedger LM, McDermott MF. TNF and TNF-receptors: From mediators of cell death and 
inflammation to therapeutic giants - past, present and future. Cytokine Growth Factor 
Rev. 2014;25(4):453-72. 
Smith L. New AHA Recommendations for Blood Pressure Measurement. Am Fam 
Physician. 2005;72(7):1391-8. 
Stubbe M, Vanderheyde N, Goldman M, et al. Antigen-specific central memory CD4+ T 
lymphocytes produce multiple cytokines and proliferate in vivo in humans. J Immunol. 
2006;177(11):8185-90. 
Verleden GM, Glanville AR, Lease ED, et al. Chronic lung allograft dysfunction: 
Definition, diagnostic criteria, and approaches to treatment-A consensus report from the 
Pulmonary Council of the ISHLT. J Heart Lung Transplant. 2019;38(5):493-503. 
doi:10.1016/j.healun.2019.03.009 
Vink P, Ramon Torrell JM, Sanchez Fructuoso A, et al. Immunogenicity and Safety of 
the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults 
Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 
2020;70(2):181-90. 
Wölfl M, Kuball J, Eyrich M, et al. Use of CD137 to study the full repertoire of CD8+ T 
cells without the need to know epitope specificities. Cytometry A. 2008;73(11):1043-9. 

Signature Page for  219900 TMF-17016141 v1.0
Signature Page for TMF-17016141 v1.0
Reason for signing: Approved
Name: 
Role: A
Date of signature: 11-Oct-2023 07:09:45 GMT+0000
Reason for signing: Approved
Name: 
Role: A
Date of signature: 11-Oct-2023 13:26:58 GMT+0000
PPD
PPD