A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Sponsor: GlaxoSmithKline

 
 
 
 
 
 
Protocol 
Official Title of Study: A phase 3, randomized, double blind, multi country study to evaluate consistency, 
safety, and reactogenicity of 3 lots of RSVPreF3 OA investigational vaccine administrated as a single dose 
in adults aged 60 years and above 
Study ID: 217131 
Approval Date of Document: 10-MAY-2021 

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Clinical Study Protocol 
Sponsor: 
GlaxoSmithKline Biologicals SA (GSK) 
Rue de l’Institut, 89 
1330 Rixensart, Belgium 
Primary study intervention(s) 
and number(s) 
GlaxoSmithKline Biologicals SA (GSK)’s 
investigational respiratory syncytial virus (RSV) 
vaccine BIO RSV OA=ADJ (GSK3844766A) 
eTrack study number and 
abbreviated title 
217131 (RSV OA=ADJ-009) 
EudraCT number 
2021-002225-18 
Date of protocol 
Final: 10 May 2021 
Title 
A phase 3, randomized, double-blind, multi-country 
study to evaluate consistency, safety, and 
reactogenicity of 3 lots of RSVPreF3 OA 
investigational vaccine administrated as a single dose 
in adults aged 60 years and above. 
Brief title 
A study of 3 lots of an investigational vaccine 
against respiratory syncytial virus (RSV) in adults 
aged 60 years and above. 
Based on GlaxoSmithKline Biologicals SA Protocol WS v17.2 
©2021 GSK group of companies or its licensor. 

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Protocol Sponsor Signatory Approval 
eTrack study number and 
abbreviated title 
217131 (RSV OA=ADJ-009) 
EudraCT number 
2021-002225-18 
Date of protocol 
Final: 10 May 2021 
Title 
A phase 3, randomized, double-blind, multi-country 
study to evaluate consistency, safety, and 
reactogenicity of 3 lots of RSVPreF3 OA 
investigational vaccine administrated as a single 
dose in adults aged 60 years and above. 
Sponsor signatory 
Veronica Hulstrøm 
Senior Clinical Research and Development Lead 
RSV Older Adults 
Signature 
 
 
 
Date 
 
Note: Not applicable if an alternative signature process (e.g. electronic signature or 
email approval) is used to get the sponsor approval 

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Protocol Investigator Agreement 
I agree: 
• 
To conduct the study in compliance with this protocol, any future protocol 
amendments or protocol administrative changes, with the terms of the clinical trial 
agreement and with any other study conduct procedures and/or study conduct 
documents provided by GlaxoSmithKline (GSK) Biologicals SA. 
• 
To assume responsibility for the proper conduct of the study at this site. 
• 
That I am aware of, and will comply with, ‘Good Clinical Practice’ (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 onsite or 
elsewhere without the approval of GSK and the express written informed consent of 
the participant. 
• 
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 process of the study 
and in 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 investigational intervention(s), and more generally about his/her 
financial ties with the sponsor. GSK will use and disclose the information solely for 
the purpose of complying with regulatory requirements. 

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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. 

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eTrack study number and 
abbreviated title 
217131 (RSV OA=ADJ-009) 
EudraCT number 
2021-002225-18 
Date of protocol 
Final: 10 May 2021 
Title 
A phase 3, randomized, double-blind, multi-country 
study to evaluate consistency, safety, and 
reactogenicity of 3 lots of RSVPreF3 OA 
investigational vaccine administrated as a single 
dose in adults aged 60 years and above. 
Investigator name 
 
 
 
Signature 
 
 
 
Date 
 
 
 

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SPONSOR INFORMATION 
1. Sponsor 
GlaxoSmithKline Biologicals SA (GSK) 
2. Sponsor medical expert for the study 
Refer to the local study contact information document. 
3. Sponsor study monitor 
Refer to the local study contact information document. 
4. Sponsor study contact for reporting of Serious Adverse Events (SAEs) 
GSK central back up study contact for reporting SAEs: refer to Section 8.3.3.1. 
Study contact for reporting SAEs: refer to the local study contact information 
document. 
5. GSK Helpdesk for emergency unblinding  
Refer to Section 6.3.4.1. 

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TABLE OF CONTENTS 
PAGE 
SPONSOR INFORMATION ............................................................................................ 6 
1. 
PROTOCOL SUMMARY ........................................................................................ 13 
1.1. 
Synopsis ..................................................................................................... 13 
1.2. 
Schema ...................................................................................................... 13 
1.3. 
Schedule of activities (SoA) ........................................................................ 14 
2. 
INTRODUCTION .................................................................................................... 15 
2.1. 
Study rationale ............................................................................................ 15 
2.2. 
Background ................................................................................................ 15 
2.3. 
Benefit/Risk assessment ............................................................................. 16 
2.3.1. 
Risk assessment .......................................................................... 16 
2.3.2. 
Benefit assessment ..................................................................... 17 
2.3.3. 
Overall Benefit/Risk conclusion .................................................... 17 
3. 
OBJECTIVES AND ENDPOINTS ........................................................................... 17 
4. 
STUDY DESIGN .................................................................................................... 18 
4.1. 
Overall design ............................................................................................. 18 
4.1.1. 
Overview of recruitment plan ....................................................... 19 
4.1.2. 
Study enrolment rules .................................................................. 20 
4.1.3. 
Care giver support ....................................................................... 20 
4.2. 
Scientific rationale for study design ............................................................. 20 
4.3. 
Justification for dose ................................................................................... 21 
4.4. 
End of Study definition ................................................................................ 22 
5. 
STUDY POPULATION ........................................................................................... 22 
5.1. 
Inclusion criteria .......................................................................................... 22 
5.2. 
Exclusion criteria ......................................................................................... 22 
5.2.1. 
Medical conditions ....................................................................... 23 
5.2.2. 
Prior/Concomitant therapy ........................................................... 23 
5.2.3. 
Prior/Concurrent clinical study experience ................................... 24 
5.2.4. 
Other exclusions .......................................................................... 24 
5.3. 
Lifestyle considerations ............................................................................... 24 
5.4. 
Screening failures ....................................................................................... 24 
5.5. 
Criteria for temporarily delaying enrolment/Study intervention 
administration ............................................................................................. 25 
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY .................................. 26 
6.1. 
Study interventions administered ................................................................ 26 
6.2. 
Preparation, handling, storage, and accountability ...................................... 27 
6.3. 
Measures to minimize bias: randomization and blinding ............................. 27 
6.3.1. 
Participant identification ............................................................... 27 
6.3.2. 
Randomization to study intervention ............................................ 27 
6.3.3. 
Intervention allocation to the participant ....................................... 27 
6.3.4. 
Blinding and unblinding ................................................................ 28 
6.3.4.1. 
Emergency unblinding ................................................ 28 
6.3.4.2. 
Unblinding prior to regulatory reporting of SAEs ......... 29 
6.4. 
Study intervention compliance .................................................................... 29 

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6.5. 
Dose modification ....................................................................................... 29 
6.6. 
Continued access to study intervention after the end of the study ............... 30 
6.7. 
Treatment of overdose ................................................................................ 30 
6.8. 
Concomitant therapy ................................................................................... 30 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................... 30 
7.1. 
Discontinuation of study intervention ........................................................... 30 
7.2. 
Participant discontinuation/withdrawal from the study ................................. 31 
7.3. 
Lost to follow-up.......................................................................................... 31 
8. 
STUDY ASSESSMENTS AND PROCEDURES ..................................................... 32 
8.1. 
Immunogenicity assessments ..................................................................... 32 
8.1.1. 
Biological samples ....................................................................... 33 
8.1.2. 
Laboratory assays ....................................................................... 33 
8.1.3. 
Immunological read-outs .............................................................. 34 
8.1.4. 
Immunological correlates of protection ......................................... 34 
8.2. 
Safety assessments .................................................................................... 34 
8.2.1. 
Pre-vaccination procedures ......................................................... 34 
8.2.1.1. 
Collection of demographic data .................................. 34 
8.2.1.2. 
Medical history ........................................................... 34 
8.2.1.3. 
Vaccination history ..................................................... 34 
8.2.1.4. 
History directed physical examination ......................... 35 
8.2.1.5. 
Warnings and precautions to administration of 
study intervention ....................................................... 35 
8.2.1.6. 
Pre-vaccination body temperature .............................. 35 
8.2.2. 
Post-vaccination procedures ........................................................ 35 
8.2.2.1. 
Safety contact at 6 months post-vaccination 
(Month 6) .................................................................... 35 
8.3. 
Adverse Events (AEs), Serious Adverse Events (SAEs) and other 
safety reporting ........................................................................................... 36 
8.3.1. 
Time period and frequency for collecting AE, SAE and 
other safety information ............................................................... 36 
8.3.2. 
Method of detecting AEs and SAEs, and other events ................. 37 
8.3.3. 
Regulatory reporting requirements for SAEs and other 
events .......................................................................................... 37 
8.3.3.1. 
Contact information for reporting SAEs and 
pIMDs ......................................................................... 38 
8.3.4. 
Treatment of adverse events ....................................................... 38 
8.3.5. 
Participant card ............................................................................ 38 
8.4. 
Pharmacokinetics ....................................................................................... 38 
8.5. 
Genetics ..................................................................................................... 38 
8.6. 
Biomarkers ................................................................................................. 38 
8.7. 
Immunogenicity assessments ..................................................................... 39 
8.8. 
Health outcomes ......................................................................................... 39 
9. 
STATISTICAL CONSIDERATIONS ........................................................................ 39 
9.1. 
Statistical hypotheses ................................................................................. 39 
9.2. 
Analysis sets ............................................................................................... 40 
9.2.1. 
Criteria for elimination from analysis ............................................ 40 
9.3. 
Statistical analyses ..................................................................................... 40 
9.3.1. 
Primary endpoint analysis ............................................................ 40 

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9.4. 
Interim analyses .......................................................................................... 41 
9.4.1. 
Sequence of analyses.................................................................. 41 
9.4.2. 
Statistical considerations for interim analysis ............................... 41 
9.5. 
Sample size determination .......................................................................... 41 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................... 42 
10.1. 
Appendix 1: Regulatory, ethical, and study oversight considerations .......... 42 
10.1.1. 
Regulatory and ethical considerations ......................................... 42 
10.1.2. 
Financial disclosure ..................................................................... 42 
10.1.3. 
Informed consent process ............................................................ 43 
10.1.4. 
Data protection ............................................................................ 43 
10.1.5. 
Committees structure ................................................................... 43 
10.1.6. 
Dissemination of clinical study data ............................................. 44 
10.1.7. 
Data quality assurance ................................................................ 44 
10.1.8. 
Source documents ....................................................................... 45 
10.1.9. 
Study and site start and closure ................................................... 46 
10.1.10. Publication policy ......................................................................... 46 
10.2. 
Appendix 2: Clinical laboratory tests ........................................................... 46 
10.3. 
Appendix 3: Adverse Events: definitions and procedures for 
recording, evaluating, follow-up, and reporting ............................................ 47 
10.3.1. 
Definition of an adverse event (AE).............................................. 47 
10.3.1.1. Events Meeting the AE Definition ............................... 47 
10.3.1.2. Events NOT Meeting the AE Definition ....................... 48 
10.3.2. 
Definition of an SAE ..................................................................... 48 
10.3.3. 
Solicited events............................................................................ 49 
10.3.4. 
Unsolicited adverse events .......................................................... 49 
10.3.5. 
Adverse events of special interest (AESIs) .................................. 50 
10.3.5.1. Potential immune-mediated diseases ......................... 50 
10.3.6. 
Clinical laboratory parameters and other abnormal 
assessments qualifying as AEs or SAEs ...................................... 53 
10.3.7. 
Recording and follow-up of AEs, SAEs, and pIMDs ..................... 53 
10.3.7.1. Time period for collecting and recording AEs, 
SAEs, and pIMDs ....................................................... 54 
10.3.7.2. Follow-up of AEs, SAEs, and pIMDs .......................... 54 
10.3.7.2.1. Follow-up during the study ...................... 54 
10.3.7.2.2. Follow-up after the participant is 
discharged from the study ...................... 54 
10.3.7.3. Updating of SAE and pIMD information after 
removal of write access to the participant’s 
eCRF .......................................................................... 55 
10.3.8. 
Assessment of intensity and toxicity ............................................. 55 
10.3.8.1. Assessment of intensity .............................................. 55 
10.3.8.2. Assessment of causality ............................................. 56 
10.3.8.3. Medically attended visits ............................................. 57 
10.3.8.4. Assessment of outcomes............................................ 58 
10.3.9. 
Reporting of SAEs and pIMDs ..................................................... 58 
10.3.9.1. Events requiring expedited reporting to GSK .............. 58 
10.3.9.2. Back-up system in case the electronic 
reporting system does not work .................................. 58 
10.4. 
Appendix 5: Abbreviations and glossary of terms ........................................ 59 
10.4.1. 
List of abbreviations ..................................................................... 59 

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10.4.2. 
Glossary of terms ......................................................................... 61 
11. REFERENCES ....................................................................................................... 65 
 

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LIST OF TABLES 
PAGE 
Table 1 
Schedule of activities (SoA) ................................................................... 14 
Table 2 
Intervals between study visits ................................................................. 15 
Table 3 
Important risks and mitigation strategy ................................................... 16 
Table 4 
Study objectives and endpoints .............................................................. 17 
Table 5 
Study groups, intervention and blinding .................................................. 19 
Table 6 
Study intervention(s) administered ......................................................... 26 
Table 7 
Contact information for emergency unblinding ....................................... 29 
Table 8 
Biological samples ................................................................................. 33 
Table 9 
Laboratory assays .................................................................................. 33 
Table 10 
Immunological read-outs ........................................................................ 34 
Table 11 
Timeframes for collecting and reporting of safety information ................. 36 
Table 12 
Timeframes for submitting SAE and other events reports to GSK .......... 37 
Table 13 
Contact information for reporting SAEs and pIMDs ................................ 38 
Table 14 
Analysis sets .......................................................................................... 40 
Table 15 
Power to demonstrate consistency between each pair of the 
3 lots in terms of RSVPreF3 IgG GMCs with 225 evaluable 
participants per group ............................................................................ 41 
Table 16 
Solicited administration site events......................................................... 49 
Table 17 
Solicited systemic events ....................................................................... 49 
Table 18 
List of potential immune-mediated diseases (pIMDs) ............................. 51 
Table 19 
Intensity scales for solicited events in adults ≥ 60 years of age .............. 55 
 

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LIST OF FIGURES 
PAGE 
Figure 1 
Study design overview ........................................................................... 18 
 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Rationale: 
GSK is developing a new RSV PreFusion protein 3 Older Adult (RSVPreF3 OA) 
investigational vaccine against respiratory syncytial virus (RSV)-associated (subtypes A 
and B) disease in adults  60 years of age (YOA). The vaccine development is currently 
in phase 3. 
The current study will assess lot-to-lot consistency in terms of immunogenicity and 
evaluate safety and reactogenicity of the 3 RSVPreF3 OA investigational vaccine lots in 
adults  60 YOA. The study is designed as a randomized, double-blind study with 
3 parallel groups. The 3 investigational groups (hereafter referred to as RSVPreF3_Grp1, 
RSVPreF3_Grp2, and RSVPreF3_Grp3) will be vaccinated with 1 of the 3 lots of 
RSVPreF3 OA investigational vaccine, each composed of unique randomized 
combinations of antigen and adjuvant lots (for details see Table 6 and Section 6.3.3). 
Note: for readability, hereafter, the “RSVPreF3 OA investigational vaccine” is also 
referred to as “RSV investigational vaccine”. 
Objectives and endpoints: 
Refer to Table 4 for an overview of the study objectives and endpoints. 
1.2. 
Schema 
Refer to Figure 1 for an overview of the study design. 

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Note: The double-line border indicates the analyses which will be performed on all data (i.e. data that are as clean as 
possible). 
● 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 
AE: adverse event; pIMDs: potential immune-mediated diseases; RSV: respiratory syncytial virus, SAE: serious 
adverse event; eCRF: electronic Case Report Form 
* Visit 2 should preferably be performed on site, but if deemed necessary (during special circumstances such as 
Coronavirus Disease 2019 [COVID-19] pandemic), this study visit can be replaced by a home visit conducted by 
qualified staff. Any information from the participant required according to study procedures and not collected during the 
home visit, can be obtained by means of a phone call conducted by the site staff. 
1. Month 6: 6 months after study intervention administration. For this contact multiple formats can be proposed by the 
study site. 
2. The blood sample on Day 1 should be drawn prior to study intervention administration. 
3. Fever is defined as temperature ≥ 38.0°C/100.4°F regardless of the location of measurement. 
4. SAEs related to study participation, or to a concurrent GSK medication/vaccine should be collected from the time of 
consent obtained (prior to study intervention administration) up to study end. 
Table 2 
Intervals between study visits 
Interval 
Planned visit interval  
Allowed interval range 
Visit 1→Visit 2 
30 days 
30-42 days 
Visit 1→Contact  
180 days 
180-210 days 
2. 
INTRODUCTION 
2.1. 
Study rationale 
GSK is developing a new RSV PreFusion protein 3 Older Adult (RSVPreF3 OA) 
investigational vaccine against respiratory syncytial virus (RSV)-associated (subtypes A 
and B) disease in adults 60 years of age (YOA). The vaccine development is currently 
in phase 3. 
The current study will assess lot-to-lot consistency in terms of immunogenicity and 
evaluate safety and reactogenicity of the 3 RSVPreF3 OA investigational vaccine lots in 
adults 60 YOA. The study is designed as a randomized, double-blind, multi-country 
study with 3 parallel groups. The 3 investigational groups (hereafter referred to as 
RSVPreF3_Grp1, RSVPreF3_Grp2, and RSVPreF3_Grp3) will be vaccinated with 1 of 
the 3 lots of RSVPreF3 OA investigational vaccine, each composed of unique 
randomized combinations of antigen and adjuvant lots (for details see Table 6 and 
Section 6.3.3). 
Note: for readability, hereafter, the “RSVPreF3 OA investigational vaccine” is also 
referred to as “RSV investigational vaccine”. 
The rationale for the study design is presented in Section 4.2. 
2.2. 
Background 
RSV is a ribonucleic acid virus of which 2 antigenically distinct subgroups exist, RSV-A 
and RSV-B [Borchers, 2013]. It is a highly contagious pathogen that causes respiratory 
tract infections in people of all ages. In temperate climates throughout the world, it 
predictably causes fall-winter epidemics. In (sub) tropical regions, viral activity is more 
endemic, and outbreaks are less temporally focused. 

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As the global population ages, the morbidity and mortality from respiratory infections 
appear to be steadily increasing in the older adult (OA) population [Lee, 2013; Binder, 
2017]. Based on epidemiological data collected prospectively in 2008-2010 in 14 
countries worldwide (including North America, Europe and East Asia), the average 
percentage of documented RSV infection in OA with influenza-like illness is 7.4%, with 
values between 0% and 17.1% across countries [Falsey, 2014]. In 2015, an estimated 1.5 
million episodes of RSV-related acute respiratory illness occurred in OA in industrialized 
countries; approximately 14.5% of these episodes involved a hospital admission [Nam, 
2019]. Further information on RSV incidence and disease burden can be found in the 
Investigator’s Brochure (IB). 
There is currently no vaccine or other prophylactic treatment available against RSV in 
OA. Currently available treatment for RSV in this age group is generally supportive in 
nature, as detailed in the IB. 
Please refer to the current IB for information regarding pre-clinical and clinical studies of 
RSVPreF3 OA investigational vaccine. 
2.3. 
Benefit/Risk assessment 
2.3.1. 
Risk assessment 
Detailed information about the known and expected benefits and potential risks (syncope, 
hypersensitivity, potential immune-mediated diseases) and reasonably expected adverse 
events (AEs) of the RSVPreF3 OA investigational vaccine can be found in the IB and 
Development Safety Update Report. 
Table 3 
Important risks and mitigation strategy 
Potential/Identified Risk 
Mitigation Strategy 
RSV investigational vaccine 
Potential immune-mediated diseases (pIMDs) are 
considered a potential risk, as for all vaccines 
containing an adjuvant system. 
Refer to Section 10.3.5.1 for details. 
Syncope and hypersensitivity. 
All participants will remain under observation at the clinical 
center for at least 30 minutes after vaccination. 
Study procedures 
Intramuscular vaccination commonly precipitates a 
transient and self-limiting local inflammatory reaction. 
This may typically include pain at injection site, 
erythema/redness, and swelling. 
As a mitigation strategy, a topical analgesic may be applied 
to the site of injection. 
Pain and bruising may occur at the site where blood 
is drawn. 
As a mitigation strategy, a topical analgesic may be applied 
to the site where blood will be taken. 
Syncope (fainting) can occur following or even before 
any blood draw as a psychogenic response to the 
needle insertion. 
All participants will remain under observation at the clinical 
center for at least 30 minutes after vaccination. 
For details of study procedures, dose, and study design justification, refer to Sections 1.3 
and 4.2. 

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4. 
STUDY DESIGN 
4.1. 
Overall design 
Figure 1 
Study design overview 
 
AE: adverse event; Grp: group; N: number of participants; pIMD: potential immune-mediated disease; RSV: respiratory 
syncytial virus; SAE: serious adverse event 
BS: blood samples. Blood samples will be collected from all participants at Visit 1 and Visit 2 to assess humoral 
immune response. 
Note: All SAEs related to study participation or a GSK concomitant medication/vaccine are to be recorded from the 
time the participant consents to participate in the study (prior to study vaccination) up to study end. 
• 
Study type: Self-contained. 
• 
Experimental design: Phase 3, randomized, double-blind, multi-country study with 
3 parallel groups (see Figure 1). 
• 
Duration of the study: ~ 6 months for each participant. 
• 
Method of study intervention allocation: Randomized. 
− 
Participants will be randomly assigned (1:1:1) to the 3 study groups 
(250 participants in each study group: RSVPreF3_Grp1, RSVPreF3_Grp2, and 
RSVPreF3_Grp3) at Visit 1 (Day 1) (see 6.3.2 for details of randomization 
procedures). 
• 
Level of blinding: Double-blind (blinded to the study intervention lots). The study 
will be conducted in a double-blind manner from study start-up to final analysis (see 
Section 9.4.1 for details), beyond which the study will be considered single-blind. 
 
 
Vaccination 
Blood sample 

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Refer to Table 5 and Section 6.3.4 for details on blinding and unblinding procedures. 
• 
Data Collection: Standardized electronic Case Report Form (eCRF). Solicited 
events and unsolicited AEs will be collected using a Participant Diary card (Paper 
Diary card). Concomitant medications/vaccinations will be collected in the Diary 
card on the day of vaccination and for 29 subsequent days (Days 1 to 30). 
• 
Safety monitoring: The study will be conducted with oversight by the project Safety 
Review Team (SRT). Please refer to Section 10.1.5 for the SRT structure. 
• 
Study groups: Refer to Figure 1 and Section 6.3.2 for an overview of the study 
groups. 
• 
Vaccination schedule: A single dose of RSVPreF3 OA investigational vaccine on 
Day 1. 
• 
Timepoint for reaching the Primary Completion Date milestone: Day 31 
(30 days post-study intervention administration). 
Table 5 
Study groups, intervention and blinding 
Study groups 
Number of 
participants 
Age 
Study intervention 
Blinding 
RSVPreF3_Grp1 
~ 250 
 60 years 
RSVPreF3 OA 
investigational vaccine 
The study will be conducted in a 
double-blind manner from study start-up 
to final analysis, beyond which the study 
will be considered single-blind. 
RSVPreF3_Grp2 
~ 250 
 60 years 
RSVPreF3 OA 
investigational vaccine 
RSVPreF3_Grp3 
~ 250 
 60 years 
RSVPreF3 OA 
investigational vaccine 
Grp: Group 
*GSK central study team will be unblinded to the data at the time of final analysis in order to prepare the Clinical Study 
Report of the final analysis. The study participants will remain blinded until the study end. 
4.1.1. 
Overview of recruitment plan 
No screening visit is planned for this study. The study is planned to be conducted at sites 
in multiple countries. The recruitment plan will be defined by each participating site. 
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 enrolment 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 enrolment of the overall targeted number of participants specified in this 
protocol. 
The procedures for participants identification/recruitment must be approved by the 
Independent Ethics Committee (IEC)/Institutional Review Board (IRB) together with the 
material intended for participants identification/recruitment and participants use. Refer to 
the Study Procedures Manual (SPM) for additional details. 

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4.1.2. 
Study enrolment rules 
Overall, participants will be enrolled in 3 age categories reflecting an approximate age 
distribution in the general population with a balance between males and females. It is 
therefore intended to enroll: 
• 
Approximately 40% of participants 60-69 YOA, approximately 30% of participants 
70-79 YOA, and approximately 10% of participants  80 YOA. The remaining 20% 
can be distributed freely across the 3 age categories. 
• 
Approximately 40% of participants from each sex; the remaining 20% can be 
distributed freely between the 2 sexes. 
4.1.3. 
Care giver support 
Study participants may decide to assign a caregiver to help them fulfilling the study 
procedures. Please refer to the Glossary 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. Each 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. 
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 (Visit 1) 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 participant if he/she 
wishes to appoint a caregiver or if there were or will be changes of caregiver. 
4.2. 
Scientific rationale for study design 
The current study is designed as a phase 3, double-blind study to assess lot-to-lot 
consistency in terms of immunogenicity and evaluate safety and reactogenicity of the 
3 RSVPreF3 OA investigational vaccine lots in adults  60 YOA. There are 3 parallel 
investigational groups (see Table 6): 
• 
RSVPreF3_Grp1 
• 
RSVPreF3_Grp2 
• 
RSVPreF3_Grp3 
All participants will receive a single dose of RSVPreF3 OA investigational vaccine at 
Visit 1 (Day 1). The 3 investigational groups will be vaccinated with 1 of the 3 lots of 
RSVPreF3 OA investigational vaccine, each composed of unique randomized 
combinations of antigen and adjuvant lots (see Table 6). Details of blinding and 
unblinding procedures are provided in Section 6.3.4. 

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The study will enroll OA ≥ 60 YOA who are primarily responsible for self-care and 
activities of daily living. Participants may have 1 or more chronic medical conditions but 
should be medically stable in the opinion of the investigator. 
As the RSVPreF3 OA investigational vaccine is adjuvanted, all participants will be 
followed up for safety for 6 months post-RSV investigational vaccine administration. 
The 120 µg RSVPreF3/AS01E vaccine formulation was selected in a previous study 
(RSV OA=ADJ-002), where the vaccine was administered intramuscularly according to a 
0, 2-month vaccination schedule. Please refer to the IB for details. 
4.3. 
Justification for dose 
Based on the results up to 1-month post-Dose 2 from study RSV OA=ADJ-002, a single 
dose regimen (0.5 mL) and the formulation of 120 µg RSVPreF3/AS01E were selected 
for further evaluation in the phase 3 clinical program. The RSV OA=ADJ-002 study was 
designed to assess the immunogenicity of a 2-dose AS01E-adjuvanted or unadjuvanted 
RSVPreF3 vaccine administered according to a 0-, 2-month schedule with the aim to 
maximize the immune response against RSV and vaccine efficacy over several seasons. 
Based on the data from clinical development programs for AS01-adjuvanted protein 
antigen vaccines in OA, such as Shingrix and the chronic obstructive pulmonary disease 
investigational vaccine, it was expected that immunological responses would reach 
higher levels 1 month post-Dose 2 as compared with 1 month post-Dose 1. However, the 
RSV OA=ADJ-002 results demonstrated that the second dose given 2 months after the 
first dose had no added value in terms of humoral and/or cellular immune responses. The 
humoral response, both in terms of RSV A neutralizing antibody geometric mean titers 
and RSVPreF3 IgG geometric mean concentrations (GMCs), peaked 1 month after the 
first dose, and the second dose did not increase the levels observed after the first dose. 
The results from study RSV OA=ADJ-002 demonstrated statistically significant 
superiority of the 120 µg formulations in terms of RSV A neutralizing titers over at least 
1 of the 30 µg and 60 µg formulations with the same adjuvant content or unadjuvanted. 
The data demonstrated an immunologic benefit of any AS01E or AS01B formulations 
over unadjuvanted formulations in terms of frequency of RSVPreF3-specific CD4+ T 
cells expressing at least 2 markers. Importantly, despite lower baseline observed in OA, 
the AS01-containing formulations induced CD4+ T cells frequencies at a close or similar 
level as in young adults, that is not observed with the unadjuvanted formulations. 
There was no safety concern detected in unadjuvanted groups to be linked to the 
RSVPreF3 antigen assessed for the first time in OA. The acceptable safety/reactogenicity 
profile in all 120 µg groups, together with the immunological benefit demonstrated for 
the 120 µg antigen dose, supports the selection of a 120 µg based formulation. The 
results also showed that all the AS01-adjuvanted formulations evaluated are considered 
to have a clinically acceptable safety profile. The AS01-adjuvanted formulation with the 
lowest reactogenicity profile, i.e., the AS01E-based formulation, was selected. The 
immunological response observed after 1 vaccine dose of the AS01E-based formulation is 
considered adequate for a RSVPreF3 OA candidate vaccine. 

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4.4. 
End of Study definition 
A participant is considered to have completed the study if he/she returns for the last visit 
or is available for the last scheduled contact as described in the protocol. 
End of Study (EoS): Last subject last visit (LSLV) (i.e., contact at 6 months post-study 
intervention administration). 
5. 
STUDY POPULATION 
Adherence to the inclusion and exclusion criteria specified in the protocol is essential. 
Deviations from these criteria are not allowed because they can jeopardize the scientific 
integrity, regulatory acceptability of the study or safety of the participant. 
5.1. 
Inclusion criteria 
All participants must satisfy ALL the following criteria at study entry: 
• 
Participants who, in the opinion of the investigator, can and will comply with the 
requirements of the protocol (e.g. completion of the diary cards, return for follow-up 
visit, ability to access and utilize a phone or other electronic communications). 
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 diaries or make 
decisions on behalf of the participant. Refer to the Glossary of terms for the 
definition of caregiver. 
• 
A male or female  60 YOA at the time of first study intervention administration. 
• 
Participants living in the general community or in an assisted-living facility that 
provides minimal assistance, such that the participant is primarily responsible for 
self-care and activities of daily living. 
• 
Written or witnessed informed consent obtained from the participant prior to 
performance of any study specific procedure. 
• 
Participants who are medically stable in the opinion of the investigator at the time of 
vaccination. Participants with chronic stable medical conditions with or without 
specific treatment, such as diabetes, hypertension or cardiac disease, can participate 
in this study if considered by the investigator as medically stable. 
5.2. 
Exclusion criteria 
The following criteria should be checked at the time of study entry. The potential 
participant MAY NOT be included in the study if ANY exclusion criterion applies: 

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5.2.1. 
Medical conditions 
• 
Any confirmed or suspected immunosuppressive or immunodeficient condition 
resulting from disease (e.g. current malignancy, human immunodeficiency virus) 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). 
• 
History of any reaction or hypersensitivity likely to be exacerbated by any 
component of the study intervention(s). 
• 
Hypersensitivity to latex. 
• 
Serious or unstable chronic illness. 
• 
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 (MMSE), Mini-Cog or Montreal Cognitive Assessment 
(MoCA) to determine cognition levels of the participant. 
• 
Recurrent or un-controlled neurological disorders or seizures. Participants with 
medically-controlled active or 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 phone call/study site visits). 
• 
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). 
• 
Any medical condition that in the judgment of the investigator would make 
intramuscular injection unsafe. 
5.2.2. 
Prior/Concomitant therapy 
• 
Use of any investigational or non-registered product (drug, vaccine or medical 
device) other than the study intervention(s) during the period beginning 30 days 
before study intervention administration and ending 30 days after study intervention 
administration, or planned use during the study period. 
• 
Planned or actual administration of a vaccine not foreseen by the study protocol in 
the period starting 30 days before and ending 30 days after the study intervention 
administration, with the exception of inactivated and subunit influenza vaccines 
which can be administered up to 14 days before or from 14 days after the study 
vaccination. 
Note: In case an 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 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 accordingly. 

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• 
Previous vaccination with an RSV vaccine. 
• 
Administration of long-acting immune-modifying drugs or planned administration at 
any time during the study period (e.g. infliximab). 
• 
Administration of immunoglobulins and/or any blood products or plasma derivatives 
during the period starting 90 days before the administration of the study intervention 
or planned administration during the study period. 
• 
Chronic administration (defined as more than 14 consecutive days in total) of 
immunosuppressants or other immune-modifying drugs during the period starting 
90 days prior to the study intervention administration or planned administration 
during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day 
or equivalent. Inhaled and topical steroids are allowed. 
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 vaccine/product (drug or invasive medical device). 
Note: EEC directive 93/42/EEC defines an invasive medical device as ‘A device 
which, in whole or in part, penetrates inside the body, either through a body orifice 
or through the surface of the body’. 
5.2.4. 
Other exclusions 
• 
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. 
• 
Planned move during the study period that will prohibit participating in the study 
until study end. 
• 
Bedridden participants. 
• 
Participation of any study personnel or their immediate dependents, family, or 
household members. 
5.3. 
Lifestyle considerations 
No lifestyle restrictions are applicable for this study. 
5.4. 
Screening failures 
Not applicable for this study. 

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5.5. 
Criteria for temporarily delaying enrolment/Study 
intervention administration 
Enrolment/study intervention administration may be postponed within the permitted time 
interval until transient conditions cited below are resolved: 
• 
Acute disease and/or fever at the time of enrolment and/or study intervention 
administration. Refer to the SoA (Table 1) for definition of fever and preferred 
location for measuring temperature in this study. 
• 
Participants with a minor illness (such as mild diarrhea, mild upper respiratory 
infection) without fever may be enrolled and/or dosed at the discretion of the 
investigator. 
• 
Participants with symptoms suggestive of active Coronavirus Disease 2019 
(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.). 
• 
Participants with known COVID-19 positive contacts may be vaccinated at least 
14 days after the exposure, provided that the participant remains symptom-free, and 
at the discretion of the investigator. 
• 
In case of administration of inactivated and subunit influenza vaccines: 
Postponement of study vaccine administration within given protocol timelines to 
allow respect of the 14-days interval between flu vaccination and study vaccine 
administration. 

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6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY 
6.1. 
Study interventions administered 
Refer to the Glossary of terms for the definition of study intervention. 
Table 6 
Study intervention(s) administered 
Study group 
RSVPreF3_Grp1 
RSVPreF3_Grp2 
RSVPreF3_Grp3 
Study intervention name: 
RSVPreF3 OA 
investigational vaccine 
RSVPreF3 OA 
investigational vaccine 
RSVPreF3 OA 
investigational vaccine 
Study intervention 
formulation: 
RSVPreF3 (120 µg) 
(Lot 1) 
RSVPreF3 (120 µg) 
(Lot 2) 
RSVPreF3 (120 µg) 
(Lot 3) 
AS01E (Lot A):  
QS-21* (25 µg), MPL 
(25 µg), liposomes; 
water for injections q.s. 
0.5 mL 
AS01E (Lot B):  
QS-21* (25 µg), MPL 
(25 µg), liposomes; water 
for injections q.s. 0.5 mL 
AS01E (Lot C):  
QS-21* (25 µg), MPL 
(25 µg), liposomes; water 
for injections q.s. 0.5 mL 
Presentation: 
RSVPreF3: Vial; powder 
for suspension for 
injection 
RSVPreF3: Vial; powder 
for suspension for 
injection 
RSVPreF3: Vial; powder 
for suspension for 
injection 
AS01E: Vial; suspension 
for suspension for 
injection 
AS01E: Vial; suspension 
for suspension for 
injection 
AS01E: Vial; suspension 
for suspension for 
injection 
Type: 
Biologic 
Biologic 
Biologic 
Route of administration:  
IM 
IM 
IM 
Administration site: 
• 
Location 
Deltoid 
Deltoid 
Deltoid 
• 
Directionality 
Upper 
Upper 
Upper 
• 
Laterality** 
Non-dominant 
Non-dominant 
Non-dominant 
Number of doses to be 
administered: 
1 
1 
1 
Volume to be 
administered by dose ***: 
0.5 mL 
0.5 mL 
0.5 mL 
Packaging, labeling and 
TM: 
Refer to the SPM for 
more details 
Refer to the SPM for more 
details 
Refer to the SPM for more 
details 
Manufacturer: 
GSK Biologicals 
GSK Biologicals 
GSK Biologicals 
Grp: group; IM: Intramuscular; SPM: Study Procedures Manual 
* QS-21: Quillaja saponaria Molina, fraction 21 (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 SPM 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 must be readily 
available during the observation period in case of anaphylaxis, syncope. 

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6.2. 
Preparation, handling, storage, and accountability 
The study interventions must be stored in a secured place within the temperature range 
specified on the study intervention’s label. The storage temperature should be 
continuously monitored and recorded with a calibrated (if not validated) temperature 
monitoring device(s). 
Only authorized study personnel should be allowed access to the study intervention. 
Storage conditions will be assessed by a sponsor study contact during pre-study activities. 
Refer to the SPM for more details on storage and handling of the study intervention(s). 
6.3. 
Measures to minimize bias: randomization and blinding 
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 
Approximately 750 eligible participants will be randomly assigned (1:1:1) to the 3 study 
groups (250 participants in each study group: RSVPreF3_Grp1, RSVPreF3_Grp2, and 
RSVPreF3_Grp3) at Visit 1 (Day 1). 
The randomization of supplies within blocks will be performed at GSK, using MATerial 
Excellence (MatEx), a program developed for use in Statistical Analysis System (SAS) 
(Cary, NC, United States [US]) by GSK. Entire blocks will be shipped to the study 
centers/warehouse(s). 
To allow GSK to take advantage of greater rates of recruitment in this multi-center study 
and thus to reduce the overall study recruitment period, an over-randomization of 
supplies will be prepared. 
6.3.3. 
Intervention allocation to the participant 
An automated Internet-based system, Source data Base for Internet Randomization 
(SBIR) will be used for randomization and for identification of intervention material. 
The randomization algorithm will use a minimization procedure accounting for age (60 to 
69, 70 to 79 or ≥ 80 years) and center. Minimization factors will have equal weight in the 
minimization algorithm. Refer to Section 4.1.2 for the enrolment rules. 
The 3 study groups for the lot-to-lot evaluation will receive adjuvanted vaccine consisting 
of unique combinations of RSVPreF3 antigen lots, i.e., Lot 1, Lot 2, or Lot 3, and 
extemporaneously reconstituted with AS01E adjuvant lots, i.e., Lot A, Lot B, and Lot C. 

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One of the combinations of the AS01E adjuvant lot and RSVPreF3 antigen lot will be in 
alignment with the RSV OA=ADJ-006 study (efficacy study). The 2 remaining adjuvant 
lots will be randomly combined with the 2 RSVPreF3 antigen lots. The random 
assignment will be done using the RAND function, that uses the Mersenne-Twister 
algorithm. Details of the study groups and antigen/adjuvant lots are presented in Table 5 
and Table 6. 
Once a participant identification number is allocated, the randomization system will 
determine study group and will provide the study intervention number to be used. 
When SBIR is not available, please refer to the SBIR user guide or SPM for specific 
instructions. 
Refer to the SPM for additional information relative to the intervention number 
allocation. 
6.3.4. 
Blinding and unblinding 
Data will be collected in a double-blind manner. The investigator and the participant will 
not know which lot of the study intervention is administrated. 
The laboratory in charge of sample testing will be blinded to the study intervention lot 
assignment. Codes will be used to link the participant and study to each sample. There 
will be no link between the study intervention groups and the identity of the participant. 
The study will be conducted in a double-blind manner from study start-up to final 
analysis, beyond which the study will be considered single-blind. The study participants 
will remain blinded up to study end, however, the investigators will receive a copy of the 
Clinical Study Report (CSR) with results of the final analyses on immunogenicity and 
safety data up to Day 31. As a consequence, the investigators could become unblinded to 
some specific participants through summary results. The individual data listings and 
participant treatment assignments will not be provided to the investigators until after the 
conclusion of the study (completion of Month 6 contact [study end]). 
Note that the GSK central study team (Clinical Research and Development Lead 
[CRDL], Statistician, Safety Representative, etc.) will be unblinded to the study 
intervention lot assignment at the time of final analysis in order to prepare the CSR of the 
final analysis. 
6.3.4.1. 
Emergency unblinding 
Unblinding a participant’s individual study intervention number should occur ONLY in 
case of a medical emergency when this information is essential for the clinical 
management or welfare of the participant. 
In case of emergency, the investigator can have unrestricted, immediate and direct access 
to the participant’s study intervention information via an automated Internet-based 
system (e.g. SBIR). The investigator may contact a GSK Helpdesk (refer to Table 7) if 
he/she needs help to access participant’s study intervention information (i.e. if the 
investigator is unable to access SBIR). 

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A physician other than the investigator (e.g. an emergency room physician) or 
participant/participant’s care giver or family member may also request emergency access 
to the participant’s study intervention information either via the investigator or 
investigator’s back up (preferred option) or via the GSK Helpdesk (back up option). The 
subject/participant card provides contact information for the investigator, his/her back up 
and GSK Helpdesk. 
Table 7 
Contact information for emergency unblinding 
GSK Helpdesk 
Available 24/24 hours and 7/7 days 
The Helpdesk is available by phone, fax and email 
Toll-free phone number(s): 
Canada 
+1 833 541 0263 
USA  
+1 844 446 3133 
Sweden: 
+32 2 656 68 04 
Fax: 
 
+32 2 401 25 75 
Email: rix.ugrdehelpdesk@gsk.com 
6.3.4.2. 
Unblinding prior to regulatory reporting of SAEs 
GSK policy requires unblinding of any unexpected SAE which is attributable/suspected 
to be attributable to the study intervention(s), prior to regulatory reporting. Vaccines 
Clinical Safety and Pharmacovigilance (VCSP) is responsible for unblinding the study 
intervention assignment within the timeframes defined for expedited reporting of SAEs 
(refer to Section 10.3.9.1). 
In addition, GSK VCSP staff may unblind the intervention assignment for any participant 
with a Suspected Unexpected Serious Adverse Reaction (SUSAR) or a SAE that is fatal 
or life-threatening. For SAEs requiring expedited reporting to 1 or more regulatory 
agencies, a copy of the report containing participant’s intervention assignment may be 
sent to investigators in accordance with local regulations and/or GSK policy. 
6.4. 
Study intervention compliance 
The study intervention is administered at the site, and participants will receive it directly 
from the investigator or designee, under medical supervision. The date of administration 
of each study intervention dose will be recorded in the source documents. 
6.5. 
Dose modification 
Section is not applicable. 

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6.6. 
Continued access to study intervention after the end of the 
study 
During the study conclusion contact, the investigator will ask each participant if they are 
interested in participating in a booster study/long-term evaluation study. If a participant is 
not interested in joining the booster study/long-term evaluation study the reason for 
refusal will be documented, when available, in the participant’s eCRF. 
6.7. 
Treatment of overdose 
Not applicable for this study. 
6.8. 
Concomitant therapy 
At each study visit/contact, the investigator or his/her delegate should question the 
participant about all medications/products taken, and vaccinations received by the 
participant. 
The following concomitant medication(s)/product(s)/vaccine(s) must be recorded in the 
eCRF: 
• 
All concomitant medications and vaccinations, except vitamins and dietary 
supplements, administered during the 30-day period following study intervention 
administration. 
• 
All concomitant medications leading to discontinuation of the study intervention or 
elimination from the analysis, including products/vaccines. Please refer to the 
Sections 5.2.2 and 9.2.1for further details. 
• 
All concomitant medication which may explain/cause/be used to treat an SAE/pIMD 
including vaccines/products, as defined in Sections 8.3.1 and 10.3.7. These must also 
be recorded in the Expedited Adverse Event Report. 
• 
Any prophylactic medication (e.g., analgesics, antipyretics) administered on the day 
of study vaccination (Day 1) in the absence of ANY symptom and in anticipation of 
a reaction to the vaccination. 
The Local Medical Lead should be contacted if there are any questions regarding 
concomitant or prior therapy. 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of study intervention 
Not applicable 

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7.2. 
Participant discontinuation/withdrawal from the study 
A participant is considered to have withdrawn from the study if no new study procedure 
has been performed or no new information has been collected for him/her since the date 
of withdrawal/last contact. 
From an analysis perspective, a study ‘withdrawal’ refers to any participant who was not 
available for the concluding contact planned in the protocol. 
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. 
The primary reason for study withdrawal will be documented in the eCRF, based on the 
list below: 
• 
Adverse events requiring expedited reporting to GSK (please refer to the section 
10.3.9.1 for the details) 
• 
Unsolicited non-serious AEs 
• 
Solicited AE 
• 
Withdrawal by participant, not due to an AE* 
• 
Migrated/Moved from the study area 
• 
Lost to follow-up 
• 
Sponsor study termination 
• 
Other (specify) 
*If a participant is withdrawn from the study because he/she has withdrawn consent and 
the reason for withdrawal was provided, the investigator must document this reason in the 
eCRF. 
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 until the event 
is resolved (see Section 10.3.7.2). 
7.3. 
Lost to follow-up 
A participant will be considered ‘lost to follow-up’ if he/she fails to return for scheduled 
visits and cannot be contacted by the study site. 
Please refer to the SPM for a description of actions to be taken before considering the 
participant lost to follow-up. 

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8. 
STUDY ASSESSMENTS AND PROCEDURES 
Protocol waivers or exemptions are only permitted when necessary for the management 
of immediate safety concerns for the participant. 
Immediate safety concerns should be discussed with the sponsor as soon as they occur or 
when the study team becomes aware of them. The purpose of this communication is to 
determine if the participant(s) should discontinue the study intervention. 
Study procedures and their timing are summarized in the SoA (Section 1.3). 
The SPM provides the investigator and site personnel with detailed administrative and 
technical information that does not impact participant safety. 
During special circumstances (e.g., COVID-19 pandemic), the specific guidance from 
local public health and other competent authorities regarding the protection of 
individuals’ welfare must be applied. For the duration of such special circumstances, the 
following measures may be implemented for enrolled participants: 
• 
Safety follow-up may be made by a telephone call, other means of virtual contact or 
home visit (from the site staff or from the home care service system), if appropriate. 
• 
Diary cards may be transmitted from and to the site by electronic means and or 
conventional mail or collected at home. 
• 
Biological samples may be collected at a different location* other than the study site 
or 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. 
*It is the investigator’s responsibility to identify an alternate location. The investigator 
should ensure that this alternate location meets International Council on Harmonisation 
(ICH) GCP requirements, such as adequate facilities to perform study procedures, 
appropriate training of the staff and documented delegation of responsibilities in this 
location. This alternate location should be covered by proper insurance for the conduct of 
study on participants by investigator and staff at a site other than the designated study 
site. Refer to European Medicines Agency Guidance on the Management of Clinical 
Trials during the COVID-19 (Coronavirus) pandemic (version 2, 27 March, 2020) for 
more details. 
Impact on the Per-Protocol Set (PPS) for immunogenicity will be determined on a case 
by case basis. 
8.1. 
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. 

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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. 
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. 
8.1.1. 
Biological samples 
Table 8 
Biological samples 
Sample type 
Quantity 
Unit 
Timepoint 
Group 
Blood for humoral response 
~10 
mL 
Visit 1 (Day 1) 
Visit 2 (Day 31) 
RSVPreF3_Grp1 
Blood for humoral response 
~10 
mL 
Visit 1 (Day 1) 
Visit 2 (Day 31) 
RSVPreF3_Grp2 
Blood for humoral response 
~10 
mL 
Visit 1 (Day 1) 
Visit 2 (Day 31) 
RSVPreF3_Grp3 
Grp: Group 
8.1.2. 
Laboratory assays 
Table 9 
Laboratory assays 
Assay type 
System 
Component 
Method 
Laboratory* 
Humoral Immunity 
(Antibody determination) 
Serum 
RSVPreF3-specific 
IgG antibody 
ELISA 
GSK 
CRO: Contract Research Organization; ELISA: enzyme-linked immunosorbent assay; Ig: immunoglobin 
*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; Sienna, Italy or to a contracted 
CRO. 
Please refer to the 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. 

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8.1.3. 
Immunological read-outs 
Table 10 
Immunological read-outs 
Blood sampling timepoint 
Subset name 
No. participants 
Component 
Type of contact and 
timepoint 
Sampling 
timepoint 
Visit 1 (Day 1) 
Pre-dose 
All participants 
~ 750 
RSVPreF3-specific 
IgG antibody 
Visit 2 (Day 31) 
Post-dose 
All participants 
~ 750 
RSVPreF3-specific 
IgG antibody 
Ig: immunoglobin 
If necessary, additional testing such as but not limited to RSV neutralization assays may 
be performed for all participants to further characterize the immune response to the RSV 
investigational vaccine. 
8.1.4. 
Immunological correlates of protection 
No generally accepted immunological correlate of protection has been demonstrated so 
far for the antigen used in the study intervention. 
8.2. 
Safety assessments 
The investigator and his/her designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE. The investigator and designees 
are responsible for following up AEs that are serious, considered related to the study 
intervention or the study, or that caused the participant’s withdrawal from the study 
intervention. 
8.2.1. 
Pre-vaccination procedures 
8.2.1.1. 
Collection of demographic data 
Record demographic data such as year of birth, sex, race and ethnicity in the participant’s 
eCRF. 
8.2.1.2. 
Medical history 
Obtain the participant’s medical history by interviewing the participant and/or review of 
the participant’s medical records. Record any relevant pre-existing conditions, signs 
and/or symptoms present prior to the study intervention in the eCRF. 
8.2.1.3. 
Vaccination history 
Obtain the participant’s vaccination history by interviewing the participant and/or review 
of the participant’s vaccination records. 

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Any vaccine administered up to 1 year before study intervention 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 
high-dose, etc.) should be recorded. 
8.2.1.4. 
History directed physical examination 
• 
History directed physical examination will be performed for each participant. 
• 
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. 
8.2.1.5. 
Warnings and precautions to administration of study intervention 
Warnings and precautions to administration of study intervention must be checked before 
the planned administration of study intervention. 
8.2.1.6. 
Pre-vaccination body temperature 
The body temperature of each participant needs to be measured prior to any study 
intervention administration and recorded in the eCRF. The route for measuring 
temperature can be oral, axillary or tympanic. If the participant has fever (fever is defined 
as temperature ≥38.0°C/100.4°F regardless the location of measurement) on the day of 
vaccination, the vaccination visit will be rescheduled. 
8.2.2. 
Post-vaccination procedures 
8.2.2.1. 
Safety contact at 6 months post-vaccination (Month 6) 
Six months after the study intervention administration (i.e. Month 6), each participant 
should be contacted to check if he/she has experienced any SAEs or any pIMDs since 
study intervention administration, and to collect information on concomitant 
medications/vaccinations. 
Multiple formats can be proposed by the site staff to organize these contacts. This contact 
may be done via email, text message, fax or phone call for example. The most 
appropriate format should be agreed between site staff and the study participant. 
Text messages, email and fax may be used as a screening to check if the participant has 
anything to report. If the participant answers "Yes" for at least 1 of the items of interest, a 
phone call must be done to get the details on the event(s). 
Data collected via phone calls and text messages will have to be recorded in source 
documents. E-mails and faxes can be archived in source documents. Receipt of the 
message must be confirmed by the participant or caregiver, as applicable. 

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8.3.2. 
Method of detecting AEs and SAEs, and other events 
Detection and recording of AE/SAE/pIMDs are detailed in Section 10.3.7. 
Assessment of AE/SAE intensity, causality, and outcome are described in Section 10.3.8. 
Open-ended and non-leading verbal questioning of participants is the preferred method of 
acquiring information related to an AE/SAE/pIMD. 
8.3.3. 
Regulatory reporting requirements for SAEs and other events 
Once an investigator (or designee) becomes aware that a study participant has 
experienced an SAE/pIMD, it must be reported to GSK using the required documentation 
and within the timeframes mentioned in Table 12. This is essential for meeting GSK legal 
obligations and ethical responsibilities for participant safety and the safety of a study 
intervention under clinical investigation. 
For SAEs/pIMDs, the investigator must always provide an assessment of causality at the 
time of the initial report, as defined in the Section 10.3.8.2. 
Local regulatory requirements and sponsor policy for preparation of an investigator 
safety report of SUSAR must be followed. These reports will be forwarded to 
investigators as necessary. 
The sponsor has the legal responsibility to notify local authorities/regulatory agencies 
about the safety of an investigational study intervention. The sponsor will comply with 
country-specific regulatory requirements related to safety reporting to the regulatory 
authority, IRB/IEC and investigators. 
Please refer to Section 10.3.9 for further details regarding the reporting of SAEs/pIMDs. 
Table 12 
Timeframes for submitting SAE and other events reports to GSK 
Type of Event 
Initial Reports 
Follow-up of Relevant Information on a 
Previous Report 
Timeframe 
Documents 
Timeframe 
Documents 
SAEs 
24 hours*, ‡‡  
electronic Expedited 
Adverse Events Report 
24 hours* 
electronic Expedited Adverse 
Events Report 
pIMDs 
24 hours**, ‡‡  
electronic Expedited 
Adverse Events Report 
24 hours* 
electronic Expedited Adverse 
Events Report 
* 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 a pIMD. 
‡‡ The investigator will be required to confirm review of the SAE/pIMD causality by ticking the ‘reviewed’ box in the 
electronic Expedited Adverse Events Report within 72 hours of submission of the SAE/pIMD. 

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8.3.3.1. 
Contact information for reporting SAEs and pIMDs 
Table 13 
Contact information for reporting SAEs and pIMDs 
Study contact for questions regarding SAEs and pIMDs 
Refer to the local study contact information document 
Back up study contact for reporting SAEs and pIMDs 
Available 24/24 hours and 7/7 days: 
GSK Clinical Safety & Pharmacovigilance 
Outside US & Canada sites: 
Fax: +32 2 656 51 16 or +32 2 656 80 09 
Email address: ogm28723@gsk.com 
US sites only: 
Fax: +1 610 787 7053 
Canadian sites only: 
Fax: +1 866 903 4718 
8.3.4. 
Treatment of adverse events 
Any medication, vaccine, or products administered, which may explain/cause/be used for 
the treatment of an SAE/pIMD should be recorded in the Expedited Adverse Event 
Report of the participant’s eCRF screen (refer to Section 10.3.9.1). 
8.3.5. 
Participant card 
The investigator (or designee) must provide the participant with a “participant card” 
containing information about the clinical study. The participant must be instructed to 
always keep the participant card in his/her/their possession for the duration of the study. 
In an emergency, this card serves to inform the responsible attending physician/care 
giver/family member that the participant is in a clinical study and that relevant 
information may be obtained by contacting the investigator or his/her back up. 
8.4. 
Pharmacokinetics 
Pharmacokinetics are not evaluated in this study. 
8.5. 
Genetics 
Genetics are not evaluated in this study. 
8.6. 
Biomarkers 
Not applicable for this study. 

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8.7. 
Immunogenicity assessments 
Immunogenicity is described in Section 8.1. 
8.8. 
Health outcomes 
Not applicable for this study. 
9. 
STATISTICAL CONSIDERATIONS 
9.1. 
Statistical hypotheses 
The assumptions, statistical hypotheses and success criteria associated to the primary 
objective to demonstrate the lot-to-lot consistency of 3 lots of the RSVPreF3 OA 
investigational vaccine in terms of immunogenicity at 30 days post-vaccination are 
described hereafter. 
• 
Endpoint: RSVPreF3 IgG-specific antibody concentration at 1-month 
post-vaccination (Day 31). 
• 
Group level summary: Antibody GMC per group. 
• 
Reference for the sample size calculation: A standard deviation (SD) of the log10 
transformed concentrations of 0.45 is used as reference. It is the highest SD observed 
in the RSV OA=ADJ 002 (208851) study among all treatment groups and humoral 
assays. 
• 
Success criteria for consistency: the 2 sided 95% confidence interval (CI) of the 
GMC ratios between each pair of the 3 lots is within the pre-defined clinical limit of 
[0.67, 1.5]. 
• 
Null hypothesis: At least 2 of the 3 vaccine lots differ by more than 1.5-fold (1 sided 
non-inferiority limit) with respect to their GMC. 
• 
Alternative hypothesis: Clinical equivalence (consistency) between each pair of the 
3 lots with respect to their GMCs. 
• 
Type I error: a 1-sided alpha of 2.5% will be used for the 6 non-inferiority tests. 
• 
Type II error: Considering a Bonferroni correction for multiplicity, the global 
Type II error will be equal to 6 time the nominal Type II error calculated for 
1 non-inferiority test. The sample size is determined to reach a global power of at 
least 90%. 

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9.2. 
Analysis sets 
Table 14 
Analysis sets 
Analysis Set 
Description 
Enrolled Set 
Participants who agreed to participate in a clinical study after completion of the 
informed consent process. * 
Exposed Set (ES) 
All participants who received the study intervention. The analysis per group will be 
performed according to the administered study intervention. 
Per Protocol Set (PPS) 
All eligible participants who received the study intervention as per-protocol, had 
immunogenicity results pre- and post-dose, complied with blood draw intervals 
(Table 2), without intercurrent conditions that may interfere with immunogenicity and 
without prohibited concomitant medication/vaccination. The analysis per group will be 
performed according to the administered study intervention. 
*All participants enrolled and included in the database will be part of the Enrolled Set. 
9.2.1. 
Criteria for elimination from analysis 
If the participant meets 1 of the criteria mentioned Sections 5.2.1 (medical conditions) or 
5.2.2 (concomitant therapy), he/she may be eliminated from per-protocol analysis. 
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 Glossary of terms for the definition of intercurrent medical 
conditions. 
9.3. 
Statistical analyses 
The Statistical Analysis Plan (SAP) will be developed and finalized before first subject 
first visit (FSFV). This section is a summary of the planned statistical analyses of the 
primary endpoints. Descriptive analyses of demography, immunogenicity, and safety will 
be detailed in the SAP. 
9.3.1. 
Primary endpoint analysis 
The primary analysis of lot-to-lot consistency will be performed on the PPS for 
immunogenicity (PPSi). 
If in any study group the percentage of vaccinated participants with serological results 
excluded from the PPSi is more than 5%, a second analysis based on the Exposed Set 
(ES) will be performed to complement the PPSi analysis. 
The 3 RSVPreF3 OA investigational vaccine lots will be compared in terms of 
RSVPreF3 IgG-specific antibody concentrations at 1-month post-vaccination, with a 
1-sided alpha of 2.5%. The 95% CIs of the GMC ratios will be computed for each pair of 
RSVPreF3 OA investigational vaccine lots (RSVPreF3_Grp1 versus RSVPreF3_Grp2, 
RSVPreF3_Grp1 versus RSVPreF3_Grp3, RSVPreF3_Grp2 versus RSVPreF3_Grp3) 
using an analysis of covariance (ANCOVA) model on the log transformation of the 
RSVPreF3 IgG concentrations. The ANCOVA model will include the vaccine group and 
the age category (60 to 69 years, 70 to 79 years, ≥ 80 years) as fixed effect and the 
baseline antibody concentration as covariates. 

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9.4. 
Interim analyses 
There is no interim analysis planned for this study. 
9.4.1. 
Sequence of analyses 
A final analysis will be conducted once all the immunogenicity data are available for the 
primary endpoint. This final analysis will include immunogenicity and safety data up to 
Visit 2 (Day 31). The individual data listings and participant treatment assignments will 
not be provided at this time. 
An end-of-study analysis with all data including the data obtained until 6 months 
post-vaccination will be performed. 
Please see Section 6.3.4 for details of blinding and unblinding procedures. 
Note that the GSK central study team (Clinical Research and Development Lead 
[CRDL], Statistician, Safety Representative, etc.) will be unblinded to the details of the 
study intervention lots at the time of final analysis in order to prepare the CSR of the final 
analysis. 
9.4.2. 
Statistical considerations for interim analysis 
Not applicable. 
9.5. 
Sample size determination 
Table 15 shows that the probability (global power) to reach the lot-to-lot consistency 
criterion (Section 9.1) with 225 evaluable participants in each vaccine lot group is at least 
91%, with a 1-sided alpha = 0.025. 
Table 15 
Power to demonstrate consistency between each pair of the 3 lots in 
terms of RSVPreF3 IgG GMCs with 225 evaluable participants per 
group 
Vaccine 
component 
Endpoints 
Reference 
SD* 
Clinically 
acceptable bounds 
for consistency 
N per 
group 
1-sided 
alpha 
Power 
Type II 
error 
RSVPreF3 
IgG-specific 
GMC 
0.45 
[0.67, 1.5] 
225 
0.025 
91% 
9% 
GMC: geometric mean concentration; Ig: immunoglobin; N = number of participants; SD: Standard Deviation (of the 
log10 transformed concentration) 
Pass 2019 (Non-Inferiority test of 2 independent means). Power = 100-the Type II error (Beta). The Type II error (Beta) 
has been adjusted using Bonferroni’s method (overall Type II error = sum of the individual Type II errors) since 
6 non-inferiority tests are needed for lot-to-lot consistency (nominal Beta for each non-inferiority test is 1.5%). 
* SD = 0.45 was selected based on the results from the RSV OA=ADJ-002 study. A conservative approach was used 
by selecting the highest value observed for SD across groups and humoral assays. 
The primary objective analysis will be performed on the PPSi. Assuming a 10% 
non-evaluable rate up to Day 31 (participants dropped-out or excluded from the PPSi), a 
total of approximately 750 participants (250 per group) will have to be enrolled in order 
to reach 225 participants evaluable for the primary objective. 
Participants who withdraw from the study will not be replaced. 

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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: 
− 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
− 
Applicable ICH Good Clinical Practice (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 for review and 
approval. These documents will be signed and dated by the investigator before the 
study is initiated. 
• 
Any protocol amendments will require IEC/IRB approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study participants. 
• 
GSK will provide full details of the above procedures to the investigator, either 
verbally, in writing, or both. 
• 
The investigator will be responsible for the following: 
− 
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/EC. 
− 
Notifying the IRB/IEC of SAE(s) 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. 
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 
study and for 1 year after completion of the study. 

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10.1.3. 
Informed consent process 
The investigator or his/her representative must fully explain the nature of the study to the 
participant and answer all questions regarding the study. 
Participants must be informed that their participation is voluntary. 
Freely given and written/witnessed informed consent must be obtained from each 
participant and/or each witness, as appropriate, prior to participation in the study. 
The content of the informed consent form must meet the requirements of 21 CFR 50, 
local regulations, ICH guidelines, Health Insurance Portability and Accountability Act 
(HIPAA) requirements, where applicable, and the IRB/IEC or study center. 
The medical record must include a statement that written or witnessed informed consent 
was obtained before the participant was enrolled in the study and the date the consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF. 
Participants must be re-consented if a new version of the ICF(s) or an ICF addendum is 
released during their participation in the study. 
A copy of the ICF(s) must be provided to the participants. 
10.1.4. 
Data protection 
Participants will be assigned a unique identifier by the sponsor. Any participant records 
or datasets transferred to the sponsor will contain only the identifier. Name and any other 
information which would identify the participant will not be transferred. 
The participants must be informed that: 
• 
His/her personal study-related data will be used by the sponsor in accordance with 
local data protection law. 
• 
His/her 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. 
• 
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, in 
accordance with the Data Privacy Notice that will be sent to the site staff. 
The participants must be notified about their rights regarding the use of their personal 
data in accordance with the data privacy section of the ICF. 
10.1.5. 
Committees structure 
GSK will obtain favorable opinion/approval to conduct the study from the appropriate 
regulatory agency, in accordance with applicable regulatory requirements, prior to a site 
initiating the study in that country. This includes IRBs/IECs for review and approval of 
the protocol and subsequent amendments, ICF and any other documentation. 

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Safety oversight will be provided by a blinded SRT composed of GSK RSV OA project 
team members. 
10.1.6. 
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. The investigator is encouraged to share the 
summary results with the study participants, as appropriate. 
GSK will provide the investigator with the randomization codes for their site only after 
completion of the full statistical analysis. 
GSK intends to make anonymized patient-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. 
10.1.7. 
Data quality assurance 
The investigator should maintain a record of the location(s) of their respective essential 
documents, including source documents (see Glossary of terms for the exact definition of 
essential and source documents). The document storage system used during the study and 
for archiving (irrespective of the type of media used) should provide for document 
identification, version history, search, and retrieval. 
Essential study documents may be added or removed where justified (in advance of study 
initiation) based on their importance and relevance to the study. When a copy is used to 
replace an original document (e.g. source documents, eCRF), the copy should fulfill the 
requirements for certified copies (see Glossary of terms for the exact definition of 
certified copies). 
All participant data related to the study will be recorded on printed or eCRF 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 eCRF. 

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The investigator must maintain adequate and accurate source documents and study 
records that include all pertinent observations on each of the site’s study participants (see 
Glossary of terms for the exact definition of source documents) that supports information 
entered in the eCRF. 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source documents or certified 
copies for such review and inspection. 
The sponsor or designee is responsible for the data management of this study including 
quality checking of the source data (see Glossary of terms for the exact definition of 
source data). 
Study monitors will perform ongoing source data verification to confirm that data entered 
in the eCRF by authorized site personnel are attributable, legible, contemporaneous, 
original, accurate, and complete. Changes to source data must be traceable, not obscure 
the original entry, and be fully explained if necessary (e.g. via an audit trail). The safety 
and rights of participants must be protected, and the study conducted in accordance with 
the currently approved protocol and any other study agreements, ICH GCP, and all 
applicable regulatory requirements. 
Quality tolerance limits (QTLs) will be pre-defined in the state location(s) to identify 
systematic issues that can impact participant safety and/or the reliability of study results. 
These pre-defined parameters will be monitored during the study. Important deviations 
from the QTLs and remedial actions taken will be summarized in the CSR. 
Study records and source documents pertaining to the conduct of this study, including 
signed ICFs, must be retained by the investigator for 25 years from issuance of the final 
CSR/equivalent summary unless local regulations or institutional policies require a longer 
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. 
10.1.8. 
Source documents 
Source documents provide evidence to establish the existence of the participant and 
substantiate the integrity of collected data. The investigator should maintain a record of 
the location(s) of their source documents. 
Data transcribed into the eCRF from source documents must be consistent with those 
source documents; any 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. 
Definitions of what constitutes source data and documents can be found in the Glossary 
of terms. 

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10.1.9. 
Study and site start and closure 
First act of recruitment 
Start of study is defined as FSFV at a country-level. 
Study/Site termination 
GSK or its designee reserves the right to close the study site or terminate the study at any 
time for any reason at its sole discretion, provided there is sufficient notice given to 
account for all participants safe exit from study. 
Regular closure of study sites will occur upon study completion. A study site is 
considered closed when all required data/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 enough notice in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include 
but are not limited to: 
• 
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 recruitment of participants by the investigator 
• 
Discontinuation of further study intervention development 
• 
Total number of participants included earlier than expected 
If the study is prematurely terminated or 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 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. 
10.1.10. 
Publication policy 
GSK aims to submit the results of the study for publication in searchable, peer reviewed 
scientific literature within 18 months from the LSLV for interventional studies and 
follows the guidance from the International Committee of Medical Journal Editors 
(ICMJE). 
10.2. 
Appendix 2: Clinical laboratory tests 
RSVPreF3 protein IgG ELISA 
Responses to the RSVPreF3 antigen will be evaluated by an indirect ELISA allowing the 
detection and the quantification of antigen-specific IgG antibodies in human serum 
samples. 

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headache, nausea, vomiting, diarrhea, influenza-like illness, and accidental trauma 
(e.g. sprained ankle) which may interfere or prevent everyday life functions but do 
not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect in the offspring of a study participant. 
f. 
Other situations 
Medical or scientific judgment must be exercised in deciding whether reporting is 
appropriate in other situations. Important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may 
jeopardize the participant or require medical or surgical intervention to prevent 1 
of the other outcomes listed in the above definition should be considered serious. 
Examples of such events are invasive or malignant cancers; intensive treatment in 
an emergency room or at home for allergic bronchospasm; blood dyscrasias; and 
convulsions that do not result in hospitalization. 
10.3.3. 
Solicited events 
a. Solicited administration site events 
The following administration site events will be solicited: 
Table 16 
Solicited administration site events 
Pain  
Redness  
Swelling  
b. Solicited systemic events 
The following systemic events will be solicited: 
Table 17 
Solicited systemic events 
Fever 
Headache 
Myalgia 
Arthralgia 
Fatigue 
Note: participants will be instructed to measure and record the temperature in the 
evening. If additional temperature measurements are taken at other times of the day, 
participants will be instructed to record the highest temperature in the diary card. 
10.3.4. 
Unsolicited adverse events 
An unsolicited AE is an AE that was not included in a list of solicited events using a 
Participant Diary. Unsolicited events must have been spontaneously communicated by a 
participant who has signed the informed consent. Unsolicited AEs include both serious 
and non-serious AEs. 

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Potential unsolicited AEs may be medically attended (i.e. symptoms or illnesses requiring 
a hospitalization, or an emergency room visit, or visit to/by a health care provider). The 
participants 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 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 or perceived as a concern by the 
participant/participant’s will be collected during an interview with the 
participants/participant’s and by review of available medical records at the next visit. 
10.3.5. 
Adverse events of special interest (AESIs) 
Potential-immune-mediated diseases are the only AESIs collected for this study. 
10.3.5.1. 
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. Adverse events that need to be 
recorded and reported as pIMDs include those listed in the Table 18 (Please refer to the 
Section 10.3.7.1 for reporting details). 
The investigator must exercise his/her 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. 

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10.3.6. 
Clinical laboratory parameters and other abnormal assessments 
qualifying as AEs or SAEs 
In the absence of a diagnosis, abnormal laboratory findings assessments or other 
abnormal results the investigator considers clinically significant will be recorded as an 
AE or SAE, if they meet the definition of an AE or SAE (refer to the Sections 10.3.1 and 
10.3.2). 
The investigator must exercise his or her medical and scientific judgment in deciding 
whether an abnormal laboratory finding, or other abnormal assessment is clinically 
significant. 
10.3.7. 
Recording and follow-up of AEs, SAEs, and pIMDs 
The participants will be instructed to contact the investigator immediately should they 
experience any signs or symptoms they perceive as serious. 
When an AE/SAE occurs, it is the investigator’s responsibility to review all 
documentation (e.g. hospital progress notes, laboratory and diagnostics reports) related to 
the event. The investigator will then record all relevant information regarding an AE/SAE 
on the eCRF. The investigator may not send photocopies of the participant’s medical 
records to GSK instead of appropriately completing the eCRF. 
There may be instances when copies of medical records for certain cases are requested by 
GSK. In this case, all participant identifiers will be blinded on copies of the medical 
records prior to submission to GSK. 
The investigator will attempt to establish a diagnosis pertaining to the event, based on 
signs, symptoms, and/or other clinical information. In such cases, the diagnosis should be 
documented as the AE/SAE instead of individual signs/symptoms. 
A Paper Diary will be used in this study to capture solicited administration site or 
systemic events. The Participant Diary will be distributed to all participants at Visit 1. 
The participant should be trained on how and when to complete the Paper Diary. If a 
participant is unable or not willing to complete the Paper Diary him/herself, he/she may 
be helped by a caregiver (refer to Glossary of terms for the definition of caregiver). 
Anyone who measures administration site or systemic events and who will record the 
event in the Paper Diary, e.g. the study caregiver, should have received a caregiver 
information letter explaining the role of the caregiver prior to completing the diary card. 
This training must be documented in the participant’s source record. 
If any individual other than the participant is making entries in the Paper Diary, their 
identity must be documented in the participant’s Diary. 
Collect and verify completed Paper Diary during discussions with the participant on 
Visit 2. 

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Any unreturned Paper Diary will be sought from the participant through telephone call(s) 
or any other convenient procedure. 
The investigator or delegate will transcribe the required information into the eCRF in 
English. 
10.3.7.1. 
Time period for collecting and recording AEs, SAEs, and pIMDs 
Refer to Table 11 in Section 8.3.1 for an overview of the protocol-required reporting 
periods for AEs, SAEs and pIMDs. 
All solicited administration site and systemic events with onset during the 4 days 
following administration of the study intervention, and all unsolicited AEs that occur 
during the 30 days following administration of the study intervention must be recorded 
into the appropriate section of the eCRF, irrespective of their intensity. 
The time period for collecting and recording SAEs and pIMDs will begin at the first 
receipt of study intervention and will end 6 months after study intervention 
administration (study end). 
All AEs/SAEs leading to withdrawal from the study will be collected and recorded from 
the time of the first receipt of study intervention until the participant is discharged from 
the study. SAEs related to study participation or to a concurrent GSK medication/vaccine 
will be collected from the time consent is obtained until the participant is discharged from 
the study. 
10.3.7.2. 
Follow-up of AEs, SAEs, and pIMDs 
After the initial AE/SAE/pIMDs or any other event of interest, the investigator is required 
to proactively follow each participant at subsequent visits/contacts. All SAEs and pIMDs 
(as defined in Section 10.3.5.1), will be followed until the event is resolved, stabilized, 
otherwise explained, or the participant is lost to follow-up. 
10.3.7.2.1. Follow-up during the study 
AEs/pIMDs documented at a previous visit/contact and defined as not recovered/not 
resolved or recovering/resolving will be reviewed at subsequent visits/contacts until the 
end of the study or the participant is lost to follow-up. 
If a participant dies during their participation in the study or during a recognized 
follow-up period, GSK will be provided with any available post-mortem findings, 
including histopathology. 
10.3.7.2.2. Follow-up after the participant is discharged from the study 
The investigator will provide any new or updated relevant information to GSK on a 
previously reported SAE/pIMD using a paper/electronic Expedited Adverse Events 
Report, as applicable. The investigator is obliged to perform or arrange for the conduct of 
supplemental clinical examinations/tests and/or evaluations to elucidate the nature and/or 
causality of the SAE/pIMD as fully as possible. 

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10.3.7.3. 
Updating of SAE and pIMD information after removal of write access to 
the participant’s eCRF 
When additional SAE or pIMD 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 faxed to the Study contact for reporting SAEs (refer to Section 
8.3.3.1 or to GSK VCSP department within the defined reporting timeframes specified in 
the Table 12). 
10.3.8. 
Assessment of intensity and toxicity 
10.3.8.1. 
Assessment of intensity 
The intensity of the following solicited AEs will be assessed as described: 
CCI - This section contained Clinical Outcome Assessment data collection questionnaires or indices, 
which are protected by third party copyright laws and therefore have been excluded.

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The maximum intensity of local injection site erythema/swelling, and fever will be scored 
at GSK as follows: 
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 (
) 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 pre-defined 
outcomes as described in the Section 10.3.2. 
10.3.8.2. 
Assessment of causality 
The investigator must assess the relationship between study intervention and the 
occurrence of each unsolicited AE/SAE using clinical judgment. Where several different 
interventions were administered, the investigator should specify, when possible, if the 
unsolicited AE/SAE could be causally related to a specific intervention. When a causal 
relationship to a specific study intervention cannot be determined, the investigator should 
indicate the unsolicited AE/SAE to be related to all interventions. 
Alternative possible causes, such as the natural history of underlying disease, 
concomitant therapy, other risk factors, and the temporal relationship of the event to the 
study intervention will be considered and investigated. The investigator will also consult 
the IB to assist in making his/her assessment. 
CCI - This section contained Clinical Outcome Assessment data collection questionnaires or 
indices, which are protected by third party copyright laws and therefore have been excluded.
CCI
CCI - This section contained Clinical Outcome Assessment data collection questionnaires or 
indices, which are protected by third party copyright laws and therefore have been excluded.

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Causality should be assessed by the investigator using the following question: 
Is there a reasonable possibility that the unsolicited AE may have been caused by the 
study intervention? 
YES 
: 
There is a reasonable possibility that the study intervention 
contributed to the AE.  
NO 
: 
There is no reasonable possibility that the AE is causally related to 
the administration of the study intervention. There are other, more 
likely causes and administration of the study intervention is not 
suspected to have contributed to the AE. 
If an event meets the criteria to be determined ‘serious’ (see Section 10.3.2), additional 
examinations/tests will be performed by the investigator to determine ALL possible 
contributing factors for each SAE. 
Possible contributing factors include: 
• 
Medical history. 
• 
Other medication. 
• 
Protocol-required procedure. 
• 
Other procedure not required by the protocol. 
• 
Lack of efficacy of the study intervention, if applicable. 
• 
An error in study intervention administration. 
• 
Other cause (specify). 
There may be situations when an SAE has occurred, and the investigator has minimal 
information to include in the initial report to GSK. However, it is very important to 
record an assessment of causality for every event before submitting the Expedited 
Adverse Events Report to GSK. 
The causality assessment is 1 of the criteria used when determining regulatory reporting 
requirements. The investigator may change his/her opinion of causality after receiving 
additional information and update the SAE information accordingly. 
10.3.8.3. 
Medically attended visits 
For each solicited and unsolicited AE the participant experiences, the participant will be 
asked if he/she received medical attention (defined as hospitalization, or an otherwise 
unscheduled visit to or from medical personnel for any reason, including emergency 
room visits). This information will be recorded in the eCRF. 

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10.3.8.4. 
Assessment of outcomes 
The investigator will assess the outcome of all unsolicited AEs (including SAEs) 
recorded during the study as: 
• 
Recovered/resolved 
• 
Recovering/resolving 
• 
Not recovered/not resolved 
• 
Recovered with sequelae/resolved with sequelae 
• 
Fatal (SAEs only). 
10.3.9. 
Reporting of SAEs and pIMDs 
10.3.9.1. 
Events requiring expedited reporting to GSK 
Once an investigator becomes aware that an SAE has occurred in enrolled participant, the 
investigator (or designee) must complete information in the electronic Expedited Adverse 
Events Report WITHIN 24 HOURS, even if the investigator does not have complete 
information on the SAE. It must be completed as thoroughly as possible, with all 
available details of the event. 
The SAE report must be updated WITHIN 24 HOURS of the receipt of updated 
information on the SAE. The investigator will always provide an assessment of causality 
at the time of the initial report. 
Refer to the Table 12 for the details on timeframes for reporting of SAEs/pIMDs. 
The investigator will be required to confirm the review of SAE causality by ticking the 
‘reviewed’ box in the electronic Expedited Adverse Events Report within 72 hours of 
submission of the SAE. 
Refer to Section 10.3.9.2 for information on back-up systems in case the electronic 
reporting system does not work. 
10.3.9.2. 
Back-up system in case the electronic reporting system does not work 
If the electronic reporting system does not work, the investigator (or designee) must fax 
or email a completed, dated and signed paper Expedited Adverse Events Report to the 
study contact for reporting SAEs (refer to Sponsor Information) or to GSK VCSP 
department within 24 hours of becoming aware of the SAE. 
Investigator (or designee) must complete the electronic Expedited Adverse Events Report 
WITHIN 24 HOURS after the electronic reporting system is working again. The 
information reported through the electronic SAE reporting system will be considered 
valid for regulatory reporting purposes. 

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10.4. 
Appendix 5: Abbreviations and glossary of terms 
10.4.1. 
List of abbreviations 
AE: 
Adverse Event 
ANCA: 
Anti-neutrophil Cytoplasmic Antibody 
ANCOVA: 
Analysis of Covariance 
AS01E: 
Adjuvant System containing MPL, QS-21 and liposome 
(25 µg MPL and 25 µg QS-21) 
CI: 
Confidence Interval 
CIOMS: 
Council for International Organizations of Medical 
Sciences 
CLS: 
Clinical Laboratory Sciences 
COVID-19: 
Coronavirus Disease 2019 
CSR: 
Clinical Study Report 
eCRF: 
electronic Case Report Form 
ELISA: 
Enzyme-Linked Immunosorbent Assay 
EoS: 
End of Study 
ES: 
Exposed Set 
FLU: 
Influenza 
FSFV: 
First Subject First Visit 
GCP: 
Good Clinical Practice 
GMC: 
Geometric Mean Concentration 
GSK: 
GlaxoSmithKline 
HIPAA: 
Health Insurance Portability and Accountability Act 
HRP: 
Horse-Radish Peroxidase 
IB: 
Investigator Brochure 
ICF: 
Informed Consent Form 
ICH: 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 

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IEC: 
Independent Ethics Committee 
IgG: 
Immunoglobulin G 
IM 
Intramuscular 
IRB: 
Institutional Review Board 
LSLV: 
Last Subject Last Visit 
MGI: 
Mean Geometric Increase 
MoCA 
Mini-Cog or Montreal Cognitive Assessment 
OA: 
Older Adults 
pIMD: 
Potential Immune-Mediated Disease 
PP: 
Per-Protocol 
PPS: 
Per-Protocol Set 
QS-21: 
Quillaja saponaria Molina, fraction 21 (Licensed by 
GSK from Antigenics Inc, a wholly owned subsidiary of 
Agenus Inc., a Delaware, USA corporation) 
QTL: 
Quality Tolerance Limit 
RSV: 
Respiratory Syncytial Virus 
SAE: 
Serious Adverse Event 
SAP: 
Statistical Analysis Plan 
SAS: 
Statistical Analysis System 
SBIR: 
Source data Base for Internet Randomization  
SPM: 
Study Procedures Manual 
SRT: 
Safety Review Team 
SUSAR: 
Suspected Unexpected Serious Adverse Reactions 
US: 
United States 
YOA: 
Years of Age 

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10.4.2. 
Glossary of terms 
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. 
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 serious AE. 
In a single-blind study, the investigator and/or his staff 
are aware of the intervention assignment but the 
participant is not. 
In a double-blind study, the participant, the investigator 
and sponsor staff who are involved in the treatment or 
clinical evaluation of the participants and the review or 
analysis of data are all unaware of the intervention 
assignment. 
Caregiver: 
A ‘caregiver’ is a person who has a continuous caring 
role for a participant or may be a person having 
substantial periods of contact with a participant and/or is 
engaged in his/her daily health care (e.g. a relative of the 
participant including family members or friends). 
In the context of this study, a caregiver can be appointed 
by the participant to oversee and support the 
participant’s compliance with protocol-specific 
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. 

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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. 
Eligible: 
Qualified for enrolment into the study based upon strict 
adherence to inclusion/exclusion criteria. 
Enrolled participant: 
‘Enrolled’ means a participant’s agreement to participate 
in a clinical study following completion of the informed 
consent process. Potential participants who are screened 
for determining eligibility for the study, but do not 
participate in the study, are not considered enrolled, 
unless otherwise specified by the protocol. 
Refer to the Section 9.2 of the protocol 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. 
eTrack: 
GSK’s tracking tool for clinical trials. 
Evaluable: 
Meeting all eligibility criteria, complying with the 
procedures defined in the protocol, and, therefore, 
included in the per-protocol analysis. 
Immunological correlate 
of protection: 
A correlate of risk that has been validated to predict a 
certain level of protection from the targeted endpoint. 
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: 
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. 
Intervention number: 
A number identifying an intervention to a participant, 
according to intervention allocation. 
Investigational vaccine: 
A pharmaceutical form of an active ingredient being 
tested in a clinical study, including a product with a 
marketing authorization when used in a way different 
from the approved form, or when used for an 
unapproved indication, or when used to gain further 
information about an approved use. 
Synonym: Investigational Medicinal Product. 

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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. 
Primary completion date: 
The date that the final participant was examined or 
received an intervention for the purpose of final 
collection of data for all primary outcomes, whether the 
clinical study was concluded according to the pre-
specified protocol or was terminated. 
Protocol amendment: 
The International Council on Harmonisation (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. 
Protocol administrative 
change: 
A protocol administrative change addresses changes to 
only logistical or administrative aspects of the study.  
Randomization: 
Process of random attribution of intervention to 
participants to reduce selection bias. 
Self-contained study: 
Study with objectives not linked to the data of another 
study. 
Site Monitor: 
An individual assigned by the sponsor and responsible 
for assuring proper conduct of clinical studies at 1 or 
more investigational sites. 

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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). 
Study intervention: 
Any investigational or marketed product(s) or placebo 
intended to be administered to a participant during the 
study. 
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. 

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11. 
REFERENCES 
Binder W, Thorsen J, Borczuk P. RSV in adult ED patients: Do emergency providers 
consider RSV as an admission diagnosis? Am J Emerg Med. 2017; 35: 1162-1165. 
Borchers AT, Chang C, Gershwin ME, et al. Respiratory syncytial virus – a 
comprehensive review. Clin Rev Allergy Immunol. 2013; 45: 331-79. 
Falsey AR, McElhaney JE, Beran J, et al. Respiratory syncytial virus and other 
respiratory viral infections in older adults with moderate to severe influenza-like illness. J 
Infect Dis. 2014;209:1873-81. 
Lee N, Lui GC, Wong KT, et al. High morbidity and mortality in adults hospitalized for 
respiratory syncytial virus infections. Clin Infect Dis. 2013; 57(8): 1069-77. 
Nam HH, Ison MG. Respiratory syncytial virus infection in adults. BMJ 2019; 366:l5021. 

Signature Page for  217131 TMF-11892685 v1.0
Signature Page for TMF-11892685 v1.0
Reason for signing: Approved
Name: Veronica Hulstrøm
Role: Approver
Date of signature: 12-May-2021 08:17:49 GMT+0000