A Phase III, Randomized, Open-label, Active Vaccine-controlled Crossover Study to Evaluate the Reactogenicity, Safety and Immune Response of Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Girls From 9 to 17 Years of Age, and in Non-pregnant Adult Women From 18 to 49 Years of Age
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Sponsor: GlaxoSmithKline

 
 
 
 
 
 
Protocol 
217354 
A Phase III, randomized, open-label, active vaccine-controlled crossover study to evaluate the 
reactogenicity, safety and immune response of unadjuvanted RSV maternal vaccine in healthy  
non-pregnant girls from 9 to 17 years of age, and in non-pregnant adult women from 18 to 49 years of age. 
 
EudraCT number: 2021-004003-41 
Date of Document: 17 MARCH 2022 
 

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217354 (RSV MAT-039) 
Protocol Amendment 1 Final 
17 March 2022 
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Clinical Study Protocol 
Sponsor: 
GlaxoSmithKline Biologicals SA (GSK) 
Primary study 
intervention(s) and 
number(s) 
GlaxoSmithKline (GSK) Biological Respiratory Syncytial 
Virus (RSV) RSVPreF3 candidate vaccine (GSK3888550A) 
Other study 
intervention(s) 
GSK Biologicals’ combined reduced-antigen-content 
diphtheria, tetanus and acellular pertussis (dTpa) vaccine 
(Boostrix [US formulation SB776423]) 
GSK Biologicals’ combined reduced-antigen-content 
diphtheria, tetanus and acellular pertussis (dTpa) vaccine 
(Boostrix [ex-US formulation SB263855]) 
eTrack study 
number and 
abbreviated title 
217354 (RSV MAT-039) 
EudraCT number 
2021-004003-41 
Date of protocol 
Final: 11 August 2021 
Date of protocol 
amendment 
Amendment 1 Final: 17 March 2022 
Title 
A Phase III, randomized, open-label, active vaccine-controlled 
crossover study to evaluate the reactogenicity, safety and 
immune response of unadjuvanted RSV maternal vaccine in 
healthy non-pregnant girls from 9 to 17 years of age, and in 
non-pregnant adult women from 18 to 49 years of age. 
Brief title 
A study to evaluate the safety and immune response to an 
unadjuvanted RSV maternal vaccine in healthy non-pregnant 
females from 9 to 49 years of age. 
Based on GlaxoSmithKline Biologicals SA Protocol WS v17.2 
©2022 GSK group of companies or its licensor. 

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Protocol Amendment 1 Sponsor Signatory Approval 
eTrack study number and 
abbreviated title 
217354 (RSV MAT-039) 
EudraCT number 
2021-004003-41 
Date of protocol 
Final: 11 August 2021 
Date of protocol amendment 
Amendment 1 Final: 17 March 2022 
Title  
A Phase III, randomized, open-label, active vaccine-
controlled crossover study to evaluate the 
reactogenicity, safety and immune response of 
unadjuvanted RSV maternal vaccine in healthy non-
pregnant girls from 9 to 17 years of age, and in non-
pregnant adult women from 18 to 49 years of age. 
Sponsor signatory 
Joon Hyung Kim, Clinical Epidemiology Project 
Lead, RSV maternal, Clinical R&D 
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 Amendment 1 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 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 and/or the participant’s legally acceptable representative (LAR). 
• 
To perform no biological assays on the clinical samples other than those described in 
the protocol or its amendment(s).  
• 
To co-operate with representative(s) of GSK in the monitoring 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 
217354 (RSV MAT-039) 
EudraCT number 
2021-004003-41 
Date of protocol 
Final: 11 August 2021 
Date of protocol amendment 
Amendment 1 Final: 17 March 2022 
Title 
A Phase III, randomized, open-label, active vaccine-
controlled crossover study to evaluate the 
reactogenicity, safety and immune response of 
unadjuvanted RSV maternal vaccine in healthy non-
pregnant girls from 9 to 17 years of age, and in non-
pregnant adult women from 18 to 49 years of age. 
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 6.3.5.1. 

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PROTOCOL AMENDMENT 1 SUMMARY OF CHANGES TABLE 
Amendment 1 (17 March 2022) 
This amendment is considered substantial / based on the criteria defined in Article 
10(a) of Directive 2001/20/EC of the European Parliament and the Council of the 
European Union because it significantly impacts the safety of participants or the 
scientific value of the study. 
Overall rationale for the current Amendment:  
This protocol has been amended to reflect the following: 
• 
Following review of data collected so far from the RSV MAT-009 study in pregnant 
women, safety signals have been identified. An imbalance in the proportion of 
preterm births and neonatal deaths have been observed in infants born to vaccinated 
mothers who received RSV maternal vaccine versus those who received a placebo. 
The safety signals are being investigated and, although at this time a cause has not 
been determined, based on the above observations, GSK has nevertheless decided to 
stop enrolment and vaccination for all actively enrolling RSV MAT studies. 
• 
There will be no new participants included in this study. However, safety monitoring 
of all 8 study participants (of the planned 252 study participants) enrolled and 
vaccinated in RSV MAT-039 study in a study site in the US will continue during the 
rest of the study period. 
• 
The vaccination planned at visit 2 is removed. Therefore, Contact 2 at Day 38 and 
Visit 3 at Day 61 are not applicable anymore. Visit 4a (Day 181) and Visit 4b (Day 
211) are replaced by a telephone contact at Day 181.  
• 
A blood sample for immunogenicity assessment in the study participants who 
received first dose of RSV Maternal vaccine will continue to be collected at Visit 2 
only. No other blood samples will be collected. 
• 
All planned objectives will be analysed and reported in a descriptive manner for the 
8 enrolled participants. 

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List of main changes in the protocol and their rationale: 
Section # and title 
Description of change 
Brief rationale 
1.2 Schema 
Changes in the schema were done to 
align with the updated study design 
Update to reflect the changes 
based on GSK’s decision to stop 
vaccination and recruitment in all 
RSV maternal studies. 
1.3 Schedule of activities 
2.3 Benefit risk assessment 
Aligned with the updated study design  
3 Study objectives and endpoints 
All safety objectives are now considered 
as primary and all immunogenicity 
objectives are considered as secondary 
4 Study design 
5 Study population 
6 Study intervention and 
concomitant therapy 
The contents of these sections may not 
be applicable as there are no more study 
activities planned, 

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TABLE OF CONTENTS 
PAGE 
SPONSOR INFORMATION ............................................................................................ 6 
PROTOCOL AMENDMENT 1 SUMMARY OF CHANGES TABLE .................................. 7 
List of main changes in the protocol and their rationale: ........................................... 8 
1. 
PROTOCOL SUMMARY ........................................................................................ 15 
1.1. 
Synopsis (Amended 17 March 2022) .......................................................... 15 
1.2. 
Schema (Amended 17 March 2022) ........................................................... 15 
1.3. 
Schedule of Activities (SoA) (Amended 17 March 2022) ............................. 17 
2. 
INTRODUCTION (AMENDED 17 MARCH 2022) ................................................... 20 
2.1. 
Study rationale ............................................................................................ 20 
2.2. 
Background ................................................................................................ 22 
2.3. 
Benefit/Risk assessment (Amended 17 March 2022) .................................. 22 
3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS (AMENDED 17 MARCH 
2022) ...................................................................................................................... 23 
4. 
STUDY DESIGN (AMENDED 17 MARCH 2022) .................................................... 23 
4.1. 
Overall design ............................................................................................. 23 
4.2. 
Scientific rationale for study design ............................................................. 25 
4.3. 
Justification for dose ................................................................................... 25 
4.4. 
End of Study definition ................................................................................ 26 
5. 
STUDY POPULATION ........................................................................................... 26 
5.1. 
Inclusion criteria .......................................................................................... 26 
5.1.1. 
Inclusion criteria (Healthy Non-pregnant Adult Women 
from 18-49 YOA) .......................................................................... 26 
5.1.2. 
Inclusion criteria (Healthy non-pregnant Girls from 9-17 
YOA) ............................................................................................ 27 
5.2. 
Exclusion criteria ......................................................................................... 27 
5.2.1. 
Medical conditions ....................................................................... 28 
5.2.2. 
Prior/Concomitant therapy ........................................................... 28 
5.2.3. 
Prior/Concurrent clinical study experience ................................... 29 
5.2.4. 
Other exclusions .......................................................................... 29 
5.3. 
Lifestyle considerations ............................................................................... 30 
5.3.1. 
Demographic data ....................................................................... 30 
5.3.2. 
Lifestyle characteristics ................................................................ 30 
5.4. 
Screening failures ....................................................................................... 30 
5.5. 
Criteria for temporarily delaying enrolment/study intervention 
administration ............................................................................................. 30 
6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY .................................. 31 
6.1. 
Study interventions administered (Amended 17 March 2022) ..................... 32 
6.2. 
Preparation, handling, storage, and accountability ...................................... 33 
6.3. 
Measures to minimise bias: randomisation and blinding (Amended 
17 March 2022) ........................................................................................... 33 
6.3.1. 
Participant identification ............................................................... 33 
6.3.2. 
Randomisation to study intervention ............................................ 33 

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6.3.3. 
Intervention allocation to the participant ....................................... 33 
6.3.4. 
Allocation of participants to assay subsets ................................... 34 
6.3.5. 
Blinding and unblinding ................................................................ 34 
6.3.5.1. 
Emergency unblinding ................................................ 34 
6.4. 
Study intervention compliance .................................................................... 34 
6.5. 
Dose modification ....................................................................................... 34 
6.6. 
Continued access to study intervention after the end of the study ............... 34 
6.7. 
Treatment of overdose ................................................................................ 34 
6.8. 
Concomitant therapy ................................................................................... 34 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................... 35 
7.1. 
Discontinuation of study intervention ........................................................... 35 
7.1.1. 
Contraindications to subsequent study intervention(s) 
administration .............................................................................. 35 
7.2. 
Participant discontinuation/withdrawal from the study ................................. 36 
7.3. 
Lost to follow-up .......................................................................................... 36 
8. 
STUDY ASSESSMENTS AND PROCEDURES ..................................................... 37 
8.1. 
Immunogenicity assessments ..................................................................... 38 
8.1.1. 
Biological samples (Amended 17 March 2022) ............................ 39 
8.1.2. 
Laboratory assays (Amended 17 March 2022)............................. 39 
8.1.3. 
Immunological read-outs (Amended 17 March 2022) ................... 40 
8.1.4. 
Immunological correlates of protection ......................................... 40 
8.1.4.1. 
RSV Maternal Vaccine ............................................... 40 
8.1.4.2. 
Boostrix ...................................................................... 40 
8.2. 
Safety assessments .................................................................................... 40 
8.2.1. 
Pre-intervention administration procedures .................................. 40 
8.2.1.1. 
Collection of demographic data .................................. 41 
8.2.1.2. 
Medical/vaccination history ......................................... 41 
8.2.1.3. 
History directed physical examination ......................... 41 
8.2.1.4. 
Pregnancy test (Amended 17 March 2022) ................ 41 
8.2.1.5. 
Warnings and precautions to administration of 
study intervention ....................................................... 41 
8.2.2. 
Clinical safety laboratory tests ..................................................... 41 
8.2.3. 
Study holding rules and safety monitoring .................................... 42 
8.2.3.1. 
Safety evaluation by the Safety Review Team ............ 42 
8.2.3.2. 
Independent Data Monitoring Committee 
Evaluation .................................................................. 42 
8.2.3.3. 
Study holding rules ..................................................... 42 
8.3. 
Adverse Events (AEs), Serious Adverse Events (SAEs) and other 
safety reporting ........................................................................................... 43 
8.3.1. 
Time period and frequency for collecting AE, SAE and 
other safety information ............................................................... 43 
8.3.2. 
Method of detecting AEs and SAEs, pregnancies and 
other events ................................................................................. 44 
8.3.3. 
Regulatory reporting requirements for SAEs, pregnancies 
and other events .......................................................................... 44 
8.3.3.1. 
Contact information for reporting SAEs, 
pregnancies and study holding rules .......................... 45 
8.3.4. 
Treatment of adverse events ....................................................... 45 
8.3.5. 
COVID-19 Infection ...................................................................... 46 

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8.3.6. 
Participant card ............................................................................ 46 
8.3.7. 
Medical device deficiencies.......................................................... 46 
8.3.7.1. 
Detection, follow-up and prompt reporting of 
medical device deficiency ........................................... 46 
8.3.7.2. 
Regulatory reporting of medical device 
deficiency when used as combination product ............ 47 
8.4. 
Pharmacokinetics ....................................................................................... 47 
8.5. 
Genetics ..................................................................................................... 47 
8.6. 
Biomarkers ................................................................................................. 47 
8.7. 
Immunogenicity assessments ..................................................................... 47 
8.8. 
Health outcomes ......................................................................................... 47 
9. 
STATISTICAL CONSIDERATIONS (AMENDED 17 MARCH 2022) ....................... 47 
9.1. 
Statistical hypotheses ................................................................................. 47 
9.2. 
Analysis sets ............................................................................................... 48 
9.2.1. 
Criteria for elimination from analysis ............................................ 48 
9.3. 
Statistical analyses ..................................................................................... 48 
9.3.1. 
Primary endpoint(s)/estimand(s) analysis .................................... 48 
9.3.1.1. 
Safety ......................................................................... 48 
9.3.2. 
Secondary endpoint(s)/estimand(s) analyses .............................. 50 
9.3.2.1. 
Immunogenicity .......................................................... 50 
9.4. 
Conduct of analyses ................................................................................... 50 
9.4.1. 
Sequence of analyses .................................................................. 50 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................... 51 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ............................................................................................ 51 
10.1.1. 
Regulatory and ethical considerations ......................................... 51 
10.1.2. 
Financial disclosure ..................................................................... 51 
10.1.3. 
Informed consent process ............................................................ 52 
10.1.4. 
Data protection ............................................................................ 52 
10.1.5. 
Committees structure ................................................................... 53 
10.1.6. 
Dissemination of clinical study data ............................................. 53 
10.1.7. 
Data quality assurance ................................................................ 54 
10.1.8. 
Source documents ....................................................................... 55 
10.1.9. 
Study and site start and closure ................................................... 55 
10.1.10. Publication policy ......................................................................... 56 
10.2. 
Appendix 2: Clinical laboratory tests ........................................................... 56 
10.2.1. 
Descriptions of the assays to be performed in the study .............. 56 
10.3. 
Appendix 3: Adverse Events: definitions and procedures for 
recording, evaluating, follow-up, and reporting ............................................ 57 
10.3.1. 
Definition of an Adverse Event (AE) ............................................. 57 
10.3.1.1. Events Meeting the AE Definition ............................... 57 
10.3.1.2. Events NOT Meeting the AE Definition ....................... 58 
10.3.2. 
Definition of an SAE ..................................................................... 58 
10.3.3. 
Solicited events ............................................................................ 59 
10.3.4. 
Unsolicited adverse events .......................................................... 59 
10.3.5. 
Adverse events of special interest (AESIs) .................................. 60 
10.3.6. 
Clinical laboratory parameters and other abnormal 
assessments qualifying as AEs or SAEs ...................................... 60 
10.3.7. 
Events or outcomes not qualifying as AEs or SAEs ..................... 60 

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10.3.7.1. Pregnancy .................................................................. 60 
10.3.8. 
Recording and follow-up of AEs, SAEs, and pregnancies ............ 61 
10.3.8.1. Time period for collecting and recording AEs, 
SAEs, and pregnancies .............................................. 62 
10.3.8.2. Follow-up of AEs, SAEs, pregnancies or any 
other events of interest ............................................... 62 
10.3.8.2.1. Follow-up during the study ...................... 62 
10.3.8.2.2. Follow-up after the participant is 
discharged from the study....................... 62 
10.3.8.2.3. Follow-up of pregnancies ........................ 62 
10.3.8.3. Updating of SAE and pregnancy information 
after removal of write access to the 
participant’s eCRF ...................................................... 63 
10.3.9. 
Assessment of intensity and toxicity ............................................. 63 
10.3.9.1. Assessment of intensity .............................................. 63 
10.3.9.2. Assessment of causality ............................................. 64 
10.3.9.3. Medically attended visits ............................................. 65 
10.3.9.4. Assessment of outcomes ............................................ 65 
10.3.10. Reporting of SAEs, pregnancies and other events ....................... 66 
10.3.10.1. Events requiring expedited reporting to GSK .............. 66 
10.3.10.2. Back up system in case the electronic reporting 
system does not work ................................................. 66 
10.4. 
Appendix 4: Contraceptive guidance and collection of pregnancy 
information .................................................................................................. 66 
10.4.1. 
Definitions .................................................................................... 66 
10.4.1.1. Woman of Childbearing Potential (WOCBP) ............... 66 
10.4.1.1.1. Women not considered as women 
of childbearing potential .......................... 67 
10.4.2. 
Contraception guidance ............................................................... 67 
10.4.3. 
Collection of pregnancy information ............................................. 68 
10.4.3.1. Female participants who become pregnant ................ 68 
10.5. 
Appendix 5: Genetics .................................................................................. 68 
10.6. 
Appendix 6: Definition of medical device AE, adverse device effect 
(ADE), serious adverse device effect (SADE) and unanticipated 
SADE (USADE) .......................................................................................... 69 
10.6.1. 
Definition of medical device AE and adverse device effect 
(ADE) ........................................................................................... 69 
10.6.2. 
Definition of medical device SAE, SADE and USADE .................. 70 
10.6.3. 
Recording and reporting of medical device AE, ADEs, 
SADEs and USADE ..................................................................... 70 
10.7. 
Appendix 7: Country-specific requirements ................................................. 71 
10.8. 
Appendix 8: Abbreviations and glossary of terms ........................................ 72 
10.8.1. 
List of abbreviations ..................................................................... 72 
10.8.2. 
Glossary of terms ......................................................................... 73 
10.9. 
Appendix 9: Protocol Amendment history ................................................... 78 
11. REFERENCES ....................................................................................................... 87 
 

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LIST OF TABLES 
PAGE 
Table 1 
Schedule of Activities ............................................................................. 17 
Table 2 
Intervals between study visits ................................................................. 20 
Table 3 
Study objectives, endpoints and estimands ............................................ 23 
Table 4 
Study groups, intervention, and blinding ................................................. 25 
Table 5 
Study interventions administered ........................................................... 32 
Table 6 
Biological samples ................................................................................. 39 
Table 7 
Laboratory assays .................................................................................. 39 
Table 8 
Immunological read-outs ........................................................................ 40 
Table 9 
Study holding rules ................................................................................. 42 
Table 10 
Timeframes for collecting and reporting of safety information 
(Amended 17 March 2022) ..................................................................... 43 
Table 11 
Timeframes for submitting SAE, pregnancy and other events 
reports to GSK ....................................................................................... 45 
Table 12 
Contact information for reporting SAEs, pregnancies and study 
holding rules ........................................................................................... 45 
Table 13 
Analysis sets .......................................................................................... 48 
Table 14 
Solicited administration site events ......................................................... 59 
Table 15 
Solicited systemic events ....................................................................... 59 
Table 16 
Intensity scales for solicited events in adults and children of 6 
years of age or more .............................................................................. 63 
Table 17 
Highly effective contraceptive methods .................................................. 68 
 

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LIST OF FIGURES 
PAGE 
Figure 1 
Study design overview ........................................................................... 24 
 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis (Amended 17 March 2022) 
Rationale:  
GSK is developing an investigational respiratory syncytial virus (RSV) maternal vaccine 
(RSVPreF3) against RSV disease in infants through maternal immunization. This study is 
a Phase 3 study to evaluate safety, reactogenicity, and immunogenicity of RSV maternal 
vaccine in non-pregnant girls 9 to17 years of age (YOA) (pediatric study group*) and in 
non-pregnant adult women 18 to 49 YOA (adult study group).  
* For purpose of this study we will classify all females between 9-17 YOA as “girls” with 
the understanding that this age range includes children (9-11 year of age) and 
adolescents: (12 to 18 [further dependent on the region]). [ICH E11, 2017] 
Objectives and endpoints/estimands of the RSV MAT-039 study are presented in Table 3. 
1.2. 
Schema (Amended 17 March 2022) 
This is a phase 3 study to evaluate safety, reactogenicity, and humoral immunogenicity of 
RSV maternal vaccine in healthy non-pregnant girls 9-17 YOA (pediatric study group) 
and in non-pregnant adult women 18-49 YOA (adult study group). 
A total of 252 participants will be enrolled in the study (126 in each age group). Each 
group will be further sub-divided into two groups (63 each), of which one will receive 
RSV maternal vaccine followed by dTpa (Boostrix) vaccine 30 days later and the other 
subgroup will receive dTpa vaccine followed by RSV maternal vaccine 30 days later. The 
randomization will ensure the following: 
• 
Approximately 63, 9-17 YOA participants in the RSV_dTpa-P group 
• 
Approximately 63, 9-17 YOA participants in the dTpa_RSV-P group 
• 
Approximately 63, 18-49 YOA participants in the RSV_dTpa-A group 
• 
Approximately 63, 18-49 YOA participants in the dTpa_RSV-A group 
Blood samples for humoral immunogenicity will be collected from all participants prior 
to RSV maternal vaccine administration, Day 31 post RSV maternal vaccine 
administration, and Day 181 post RSV maternal vaccine administration. (See Section 4.1 
for details). 
Based on all safety information available from RSV MAT-009 study (following 
administration of RSV MAT vaccine), there will be no further enrollment and 
vaccination of participants in this study.  
There will be no more blood samples collected as part of this study, except the study 
participants who has received RSV maternal vaccine at Visit 1. A blood sample will be 
collected and a urine pregnancy test will continue to be performed for them at Visit 2. 

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Participants who are enrolled and are due to receive dTpa during their Visit 2 will no 
longer receive the dTpa as part of this study. However, as per the local standard of care 
and or immunization recommendation and after consultation with their attending 
physician; the participant can always receive any commercially available dTpa vaccine. 
GSK will bear the cost of the vaccine. 
All participants who receive the first dose of study interventions (RSV maternal vaccine 
or dTpa) will be followed for safety and reactogenicity and evaluated for both solicited 
administration site (local) and systemic events within 7 days of vaccination, unsolicited 
AEs within 30 days of vaccination, SAEs and pregnancy outcomes throughout the study 
period (180 days after first dose of study interventions). 
All safety data will be reviewed by a Safety Review Team (SRT) and an independent data 
monitoring committee (IDMC). (See Section 8.2.3 for more details) 
 

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1.3. 
Schedule of Activities (SoA) (Amended 17 March 2022) 
Table 1 
Schedule of Activities 
Type of contact 
Visit 1 
Contact 1 
Visit 2 
Contact 2 
 
Time points 
Day 1 
Day 8 
Day 31 
Day 181 
 
Sampling time points 
Pre-1st 
Vaccination 
Post-1st 
Vaccination 
Post 
Vaccination 
 
 
Post-
Vaccination 
 
Informed consent  
● 
 
 
 
 
 
See Section 10.1.2 for 
details] 
Assign participant number 
● 
 
 
 
 
 
 
Check inclusion/exclusion criteria 
● 
 
 
 
 
 
Recheck clinical status 
before randomisation 
and/or 1st dose of study 
intervention. See Sections 
5.1 and 5.2 for Inclusion 
and Exclusion criteria] 
Collect demographic data1 
● 
 
 
 
 
 
See Section 8.2.1.1 for 
more information] 
Medical and vaccination history  
● 
 
 
 
 
 
See Section 8.2.1.2 for 
more information] 
Physical examination and vital signs2,4 
● 
 
 
● 
 
 
See Section 8.2.1.3 for 
more information] 
Urine pregnancy test 3 
● 
 
 
● 
 
 
See Section 8.2.1.4 for 
more information] 
Pre-vaccination body temperature  
● 
 
 
 
 
 
The preferred location for 
measuring temperature will 
be oral cavity/axillary 
Randomization 
● 
 
 
 
 
 
[See Section 6.3 for more 
information] 
Check contraindications to subsequent vaccine(s) administration  
 
 
 
 
 
 
See Sections 7.1.1 and 
8.2.1.5 for more 
information] 

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Type of contact 
Visit 1 
Contact 1 
Visit 2 
Contact 2 
 
Time points 
Day 1 
Day 8 
Day 31 
Day 181 
 
Sampling time points 
Pre-1st 
Vaccination 
Post-1st 
Vaccination 
Post 
Vaccination 
 
 
Post-
Vaccination 
 
Blood sampling for humoral immune response (~5 mL) 
● 
 
 
●, 
 
 
See Section 8.1.1 for more 
information]. This is 
applicable for study 
participants who 
received RSV maternal 
vaccine at Visit 1. 
Study group and treatment number allocation (SBIR)  
O 
 
 
 
 
 
See Section 6.3.2 and 
6.3.3 for more information] 
Vaccine administration  
● 
 
 
 
See Section 6.1 for more 
information] 
Recording of administered treatment number  
 
● 
 
 
 
 
 
30 minutes post-vaccination observation period  
 
O 
 
 
 
 
 
Distribution of participant card 
 
O 
 
 
 
 
 
Training on use of e-diary  
 
O 
 
 
 
 
 
Distribution of e-diary device7 
 
O 
 
 
 
 
 
Review of e-diary 
 
 
 
 
 
 
See Section 10.3.8 for 
more information] 
Return of e-diary device11 
 
 
 
 
O 
 
 
Collection of solicited adverse events (Days 1 to 7 post-vaccination)8 
 
O 
O 
 
 
 
See Section 10.3.8 for 
more information] 
Recording of unsolicited adverse events for 30 days (days 1 to 30 post-
vaccination) 
 
● 
● 
 
● 
 
See Section 10.3.8 for 
more information] 
Recording of AEs/SAEs leading to withdrawal 
 
● 
● 
 
● 
● 
See Section 10.3.8 for 
more information] 
Recording of SAEs7  
 
● 
● 
 
● 
● 
See Section 10.3.8 for 
more information] 
Recording of MAEs  
 
● 
● 
 
● 
 
See Section 10.3.8 for 
more information] 
Recording of pregnancies (if any)  
 
 
● 
 
● 
● 
See Section 10.3.8 for 
more information] 
Recording of concomitant medications/vaccinations associated with an AE 
 
● 
● 
 
● 
● 
See Section 6.8 for more 
information] 

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Type of contact 
Visit 1 
Contact 1 
Visit 2 
Contact 2 
 
Time points 
Day 1 
Day 8 
Day 31 
Day 181 
 
Sampling time points 
Pre-1st 
Vaccination 
Post-1st 
Vaccination 
Post 
Vaccination 
 
 
Post-
Vaccination 
 
Phone contact 
 
 
● 
 
 
● 
 
Screen failed participants 
● 
 
 
 
 
 
 
Suspected, probable and confirmed cases of COVID-19 infection 
● 
 
● 
● 
 
● 
 
Screening Conclusion 
● 
 
 
 
 
 
 
Study conclusion 
 
 
 
 
 
 
See Section 4.4 for more 
information 
TC= Telephone contact 
● Indicates a study procedure that requires documentation in the individual eCRF. 
○ Indicates a study procedure that does not require documentation in the individual eCRF 
1 Date of birth (month and year or year only, as per local regulations), race, ethnicity. 
2 Physical examination including (height and weight) BMI as well as resting vital signs (blood pressure, heart rate and respiratory rate, temperature) after at least 10 minutes of rest. 
At Day 1 (Visit 1) physical exams to be done and vital signs be measured.  
At Day 31 (Visit 2) height and weight to be taken, physical exams to be done and vital signs be measured. However, BMI will not be calculated  
3 Urine pregnancy test is sufficient to determine the eligibility to enter the study. Serum pregnancy test (instead of urine test) may be performed if required by country, local or ethics 
committee regulations. 
4 Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature in this study is the oral cavity. 
6 
7The e-diary device will be distributed /or an app will be installed to the participants device at the day of vaccination. 
8SAEs related to study participation or concurrent GSK intervention product will be monitored from the time of screening to the time of the immunization. Both will be conducted on the 
same visit. 
11 Return of the e-Device is not applicable if the participant has a “Bring Your Own” e-device. 
 

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Table 2 
Intervals between study visits 
Interval 
Optimal timing  
Allowed interval (Study day) 
Visit 1*→ Contact 1 
8 days  
7 - 9 days  
Visit 1→ Visit 2 
31 days 
31 - 45 days  
Visit 1 →Contact 2 
180 days 
165 - 195 days  
*The interval between study visits begins at the time of vaccination during Visit 1 timepoint. 
2. 
INTRODUCTION (AMENDED 17 MARCH 2022) 
2.1. 
Study rationale 
GlaxoSmithKline Biologicals SA (GSK) is developing an investigational respiratory 
syncytial virus (RSV) maternal vaccine (RSVPreF3) against RSV disease in infants 
through maternal immunization with the aim of preventing RSV-associated lower 
respiratory tract illnesses in their infants by transfer of maternal antibodies. The vaccine 
candidate is an engineered version of the RSV fusion (F) surface glycoprotein, stabilized 
in the pre-fusion conformation. This study will be a Phase 3 randomized, open label, 
active vaccine-controlled crossover study to the evaluate safety, reactogenicity, and 
immunogenicity of RSV maternal vaccine in healthy non-pregnant adolescent girls from 
9 to 17 years of age (YOA), and in non-pregnant adult women from 18 to 49 YOA. The 
lower age cut-off is set as 9 years of age corresponding to the earliest onset of puberty in 
girls per ICH E11 guideline. 
The RSV maternal vaccine was being developed by GSK to be administered to pregnant 
women. By including pregnant adolescents in the target population for vaccination, their 
infants were expected to be protected from RSV for first 6 months of life thus increasing 
the number of infants who can benefit from this vaccine. RSV prevention is even more 
crucial in this population as babies of adolescent mothers face higher risks of low birth 
weight, preterm delivery, and severe neonatal conditions [WHO, 2016]. Hence these 
babies also have a higher risk of developing severe RSV disease [CHMP, 2018] which 
justifies the need to vaccinate the pregnant adolescent population with maternal RSV 
vaccine. 
Because it is not feasible to conduct a study including all age groups of pregnant 
adolescents due to the low occurrence of young adolescent pregnancies this study is 
conducted in non-pregnant girls including a direct comparison to non-pregnant adult 
women in terms of immunological non-inferiority. RSV MAT-039 is part of an approved 
Pediatric Investigation Plan in Europe. 
In the RSV maternal program to date, a Phase 1/2 study (RSV MAT-001; NCT 
03674177) in healthy non-pregnant women 18-45 years of age to determine the safety 
and immunogenicity of 3 dose levels of RSV (RSVPreF3) maternal vaccine (30, 60 and 
120 µg) compared to placebo has been completed. No safety concerns have been 
identified.  

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Based on preliminary results of RSV MAT-001, the 60 and 120 µg dose-levels were 
selected for further evaluation in the following 2 additional studies, which are ongoing:  
• 
RSV-MAT 004 (NCT 04126213): A Phase II observer-blind study to assess safety, 
reactogenicity, and immunogenicity of GSK Biologicals’ investigational RSV 
maternal unadjuvanted vaccine (GSK3888550A), in healthy pregnant women and 
infants born to vaccinated mothers 
• 
RSV-MAT 011 (NCT 04138056): A Phase II study of 2 dose levels of an 
investigational RSV maternal vaccine, given alone or with dTpa, to healthy non-
pregnant women to assess safety, reactogenicity, and immunogenicity.  
The 120-µg dose has demonstrated robust immunogenicity and there were no safety 
concerns. It was, therefore, selected for evaluation in the Phase 3 studies: the ongoing 
trial RSV MAT-009 (NCT 04605159) which is a Phase III double-blind study to assess 
safety and efficacy of an RSV maternal unadjuvanted vaccine, in pregnant women and 
infants born to vaccinated mothers. Also ongoing is the RSV MAT-012 trial, that is 
designed to assess the safety, reactogenicity and immunogenicity in the high-risk 
obstetric population. 
The objective of this study is to evaluate the immunogenicity as well as safety and 
reactogenicity of RSV maternal vaccine in healthy non-pregnant girls 9-17 YOA 
(pediatric study group*) and in non-pregnant adult women 18-49 YOA (adult study). 
* For purpose of this study we will classify all females between 9-17 YOA as “girls” with 
the understanding that this age range includes children (9-11 year of age) and 
adolescents: (12 to 18 [further dependent on the region]). [ICH E11, 2017] 
In this study, Boostrix will be used as an active vaccine. Two formulations of dTpa 
vaccine, each containing either 300 µg or 500 µg of Aluminum are licensed in the US 
and outside of the US (ex-US), respectively. Boostrix-US formulation (dTpa_300) will be 
administered to participants in centers located in the US, while the Boostrix-ex-US 
formulation (dTpa_500) will be administered to participants in centers ex-US [Christy, 
1995]. Even though two different formulations for Boostrix are available, both have a 
similar immunogenicity and safety profiles. [Theeten, 2005] 
Objectives and endpoints/estimands of the RSV MAT-039 study are presented in Section 
3. 
• 
Following review of data collected so far from the RSV MAT-009 study in 
pregnant women, safety signals have been identified. An imbalance in the 
proportion of preterm births and neonatal deaths have been observed in infants 
born to vaccinated mothers who received RSV maternal vaccine versus those who 
received a placebo. The safety signals are being investigated and, although at this 
time a cause has not been determined, based on the above observations, GSK has 
nevertheless decided to stop enrolment and vaccination for all actively enrolling 
RSV MAT studies. 
• 
There will be no new participants included in this study. However, safety 
monitoring of all 8 study participants (of the planned 252 study participants) 

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enrolled and vaccinated in RSV MAT-039 study in a study site in the US will 
continue during the rest of the study period. 
• 
The vaccination planned at visit 2 is removed. Therefore, Contact 2 at Day 38 and 
Visit 3 at Day 61 are not applicable anymore. Visit 4a (Day 181) and Visit 4b (Day 
211) are replaced by a telephone contact at Day 181.  
• 
 A blood sample for immunogenicity assessment in the study participants who 
received first dose of RSV Maternal vaccine will continue to be collected at Visit 2 
only. No other blood samples will be collected. 
• 
All planned objectives will be analysed and reported in a descriptive manner for 
the 8 enrolled participants. 
2.2. 
Background 
Please refer to the current Investigator’s Brochure (IB) for background information on 
RSV infection, the rationale for the maternal immunization approach described in this 
protocol, and information regarding pre-clinical and clinical studies of the RSV maternal 
vaccine and epidemiology studies of RSV infection. 
2.3. 
Benefit/Risk assessment (Amended 17 March 2022) 
GSK has included provisions in this trial to ensure participant’s safety. Safety monitoring 
has been and will be conducted throughout this study by an unblinded Independent Data 
Monitoring Committee (IDMC) and by the Sponsor. Measures to suspend the study 
should a potential safety issue be identified are described in Section 8.2.3. 
Following a recommendation from the IDMC, the Sponsor made the decision to pause 
the enrollment, randomization and vaccination of pregnant study participants in our 
active studies based on an observation of imbalance of the proportion of preterm births 
between the vaccine group and the placebo group in the RSV MAT-009 study in 
pregnant women. This pause was to allow for an evaluation of the available data in 
RSV MAT-009 to better understand the safety signal observed. Following a review of 
additional unblinded data from RSV MAT-009 trial in which a higher proportion of 
neonatal deaths reported in the treatment group compared to the placebo group was 
also observed, the Sponsor decided to STOP enrollment and vaccination in these 
studies.  
The safety signals are being investigated and, although at this time a cause has not 
been determined, as a precautionary measure GSK stopped active enrollment and 
further vaccination of participants in the RSV MAT studies enrolling both pregnant 
women on February 25, 2022 and non-pregnant women on March 1, 2022. The study 
remains ongoing for safety follow-up. Participants already vaccinated will continue to 
be monitored until the end of the study. 

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3. 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS 
(AMENDED 17 MARCH 2022) 
Table 3 
Study objectives, endpoints and estimands  
Objectives 
Endpoint(s) and estimand(s) 
Primary 
• 
To evaluate the safety following administration 
of RSV maternal vaccine in the pediatric (9-17 
YOA) and adult (18-49 YOA) study groups during 
the entire study period. (180 days post RSV 
maternal vaccination) 
The number and percentage of participants in each 
study group reporting  
• 
SAEs during the entire study period 
• 
AEs/SAEs/leading to study withdrawal during 
the entire study period  
• 
To evaluate the reactogenicity and safety following 
administration of RSV maternal vaccine and dTpa 
control vaccine in the pediatric and adult study 
groups up to 30 days (including day of study 
intervention administration). 
• 
The number and percentage of participants in each 
study group reporting  
• 
Each solicited administration site event collected 
during the 7 days follow-up post Dose 1 (Day 1 to 
Day 7 post intervention including day of vaccination)  
• 
Each solicited systemic event during the 7 days 
follow-up period post Dose 1 
• 
Each unsolicited AE collected during the 30 days 
follow-up period post Dose 1 
• 
SAEs/MAEs during the 30 days follow-up period 
post Dose 1 
• 
AEs/SAEs/MAEs leading to study withdrawal for the 
30 days follow-up period post Dose 1  
Secondary 
• 
To evaluate the immunogenicity following the 
administration of RSV maternal vaccine in terms 
of RSV A neutralizing Ab titers in pediatric (9-17 
YOA) and in adult (18-49 YOA) groups.  
• 
RSV A neutralizing antibody titers at pre-dosing 
and Day 31 post RSV maternal vaccine 
administration 
• 
To evaluate the immunogenicity (RSVPreF3 IgG, 
RSV A Neutralizing Ab and RSV B Neutralizing Ab) 
of RSV maternal vaccine in the pediatric (9-17 YOA) 
and 18-49 YOA (adult) groups. 
• 
RSV B Neutralizing Ab titers and RSVPreF3 IgG 
ELISA concentration at pre-dosing and Day 31, post 
RSV maternal vaccine administration. 
Details related to attributes of estimand covering intercurrent events, population and 
treatment definition are provided in the Section 9. 
4. 
STUDY DESIGN (AMENDED 17 MARCH 2022) 
4.1. 
Overall design 
This study will be a Phase 3 study to evaluate immunogenicity, safety and reactogenicity 
of RSV maternal vaccine in healthy non-pregnant girls 9 to17 YOA (pediatric study 
group) compared to non-pregnant adult women 18 to 49 YOA (adult study group).  
A total of 252 participants were planned to be enrolled evenly in 2 age groups, (9-17 
YOA and 18-49 YOA). Within each age group, approximately 126 participates will be 
randomized in 1:1 fashion either receiving RSV maternal vaccine followed by dTpa 
vaccine 30 days later or receiving Boostrix vaccine followed by RSV maternal vaccine 30 
days later. See section 6.3.2 for more detail on the randomization strategy. 

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Figure 1 
Study design overview 
 
* Screening and vaccination will happen on Visit 1 (Day 1).  
** (RSV_dTpa-P & RSV_dTpa-A) Blood sampling to be done at Visit 1 and Visit 2 for participants receiving RSV 
maternal vaccine at Visit 1.A urine pregnancy test will be done at Visit 2 if the participant has received RSV 
maternal vaccine in their first visit.  
• 
Study Type: Cross over design.  
• 
Study Duration: The study interventions were administered at Visit 1 and the 
participant will be followed for 6 months (180 days post RSV maternal vaccine 
administration) subsequent the RSV maternal vaccine until the study conclusion. 
• 
Blinding: This study will be an open label study. 
• 
Control Used: dTpa will be used as an active control for safety and reactogenicity 
evaluation and to maximize the benefit to participants*.  
* The participants in RSV_dTpa-P and RSV_dTpa-A group will be provided with 
an option to decide to receive dTpa vaccination as part of standard of care/local 
recommendation on immunization outside this study. 
• 
Sample Collection Time Points  
− 
RSV_dTpa-P: Day 1, Day 31 
− 
RSV_dTpa-A: Day 1, Day 31  
• 
Vaccination schedules are described in Table 2.  
• 
Randomized intervention allocation is described in in Table 4 and Section 6.3. 

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• 
Study (intervention) groups are described in Table 4. 
• 
Data collection: e-Diaries will be used to collect solicited event data. Unsolicited 
Adverse event data will be collected through questioning at study visits/contacts and 
reported into the eCRF, as appropriate. See Section 8.3.2 for more detail. 
• 
Safety monitoring will be conducted by SRT and IDMC. 
Table 4 
Study groups, intervention, and blinding 
Study groups** 
Number of 
participants# 
Age 
(Min-Max  
Study intervention(s)* 
Blinding 
Visit1→Visit 4a 
or Visit 4b 
RSV_dTpa-P 
63 
9-17 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
Open Label 
dTpa_RSV-P 
63 
9-17 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
RSV_dTpa-A 
63 
18-49 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
dTpa_RSV-A 
63 
18-49 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
*RSVPreF3=RSV maternal Vaccine 
#Only 8 study participants have been enrolled in the study.  
**There will no further enrolment and vaccination in all the study groups. 
4.2. 
Scientific rationale for study design 
This study is part of a clinical development plan of the RSV maternal vaccine for the 
protection of infants from RSV lower respiratory tract infections through maternal 
immunization. This study will evaluate the immunogenicity, safety and reactogenicity of 
the RSV maternal vaccine in non-pregnant girls from 9 to 17 YOA in order to show that 
the humoral immunogenicity is non inferior to the immunogenicity, safety and 
reactogenicity observed in non-pregnant adult women aged 18 to 49 YOA. 
Following the decision to stop all RSV maternal studies, this study will only explore 
immunogenicity and safety of RSV MAT vaccine in study participants (who received 
fist dose at Visit 1) 9 to 17 years of age and 18 to 49 years of age and non-inferiority 
between the groups will not be assessed.  
4.3. 
Justification for dose 
A single formulation of the investigational RSV maternal vaccine (containing 120 µg of 
the RSVPreF3 antigen) is proposed. Currently available data suggest that the 120 µg 
formulation has an acceptable safety profile and tends to elicit stronger immune 
responses in non-pregnant (RSV MAT-001 and RSV MAT-011) and pregnant (RSV 
MAT-004) women, which is likely to result in higher placental transfer of antibodies to 
the fetus than formulations containing 30 or 60 µg of the RSVPreF3 antigen. Available 
results from these studies are included in the Investigator Brochure. 
It is assumed that nearly all humans are infected with RSV in their early life and have 
pre-existing neutralizing antibody. Results of study RSV MAT-001 in non-pregnant 
women indicate that a single dose of the study vaccine is sufficient to boost the 
neutralizing antibodies induced by previous natural infections. 

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4.4. 
End of Study definition 
A participant is considered to have completed the study if she is available for the last 
scheduled contact as described in the protocol. 
End of Study (EoS): Date of the last testing/reading released of the Human Biological 
Samples, related to primary and secondary endpoints. EoS must be achieved no later than 
8 months after LSLV.  
The Primary Completion Date (PCD) is the day that the final participant is examined for 
all primary outcomes (Day 181). 
Refer to Section 10.8.2 for the definition of EoS. 
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 jeopardise 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: 
5.1.1. 
Inclusion criteria (Healthy Non-pregnant Adult Women from 18-49 
YOA) 
• 
Participants who, in the opinion of the investigator, can and will comply with the 
requirements of the protocol (e.g. completion of the e-diary, return for follow-up 
visits) 
• 
Written or witnessed/thumb printed informed consent obtained from the participant 
prior to performance of any study-specific procedure. 
• 
A healthy female participant, as established by medical history and clinical 
examination, between and including 18 to 49 YOA at the time of the first study 
intervention administration. 
• 
Body mass index (based on participant’s report) 17.0 to 39.9 kg/m2, inclusive for 
adult participants. 
• 
Female participants of childbearing potential may be enrolled in the study, if the 
participant: 
− 
has practiced adequate contraception for 1 month prior to study intervention 
administration, and 
− 
has a negative pregnancy test on the day of study intervention administration, and 
− 
has agreed to continue adequate contraception during the entire treatment period 
and for 1 month after completion of the study intervention administrations. 

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• 
Female participants of non-childbearing potential may be enrolled in the study. Non-
childbearing potential is defined as, current bilateral tubal ligation or occlusion, 
hysterectomy, bilateral ovariectomy or post-menopause.  
5.1.2. 
Inclusion criteria (Healthy non-pregnant Girls from 9-17 YOA) 
• 
Participants and participants’ parent(s)/Legally Acceptable Representative(s) (LAR), 
who, in the opinion of the investigator, can and will comply with the requirements of 
the protocol (e.g. completion of the e-diary return for follow-up visits) 
• 
Written or witnessed/thumb printed informed consent obtained from the 
participant*/parent(s)/LAR(s) of the participant prior to performance of any study-
specific procedure.  
− 
* Written informed consent obtained from parents/LARs and written informed 
assent obtained from the participant if she is less than legal age. The legal age is 
determined according to local regulations in each participating country.  
− 
In case the legal age is achieved during the conduct of the study, an additional 
written informed consent from the participant should be obtained at the time of 
the legal age. 
• 
A healthy female participant between and including 9 and 17 YOA at the time of the 
first study intervention administration. 
− 
Female participants of non-childbearing potential may be enrolled in the study. 
Non-childbearing potential is defined as pre-menarche, current bilateral tubal 
ligation or occlusion, hysterectomy, or bilateral ovariectomy.  
• 
Body mass index by age between 5 percentile and 95 percentile (inclusive) for 
pediatric participants. 
• 
Female participants of childbearing potential may be enrolled in the study, if the 
participant: 
− 
has a negative pregnancy test on the day of study intervention administration, 
and is abstinent during the entire treatment period and for 1 month before and 
after completion of the study intervention administration series (and if so, this is 
to be documented in the source documents at each vaccination visit)  
− 
or has practiced adequate contraception for 1 month prior to study intervention 
administration and has agreed to continue adequate contraception during the 
entire treatment period and for 1 month after completion of the study 
intervention administration series.  
5.2. 
Exclusion criteria 
The following criteria should be checked at the time of study entry. (Please see Section 
5.5 for more information on delay of vaccination for temporary exclusion Criteria). 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 clinical condition that, in the opinion of the investigator, might pose additional 
risk to the participant due to participation in the study. 
• 
History of any reaction or hypersensitivity likely to be exacerbated by any 
component of the study intervention(s) 
• 
Any confirmed or suspected immunosuppressive or immunodeficient condition, 
based on medical history and physical examination (no laboratory testing required) 
• 
Current autoimmune disorder (based on medical history and physical examination;), 
for which the participant has received immune-modifying therapy within 6 months, 
before study vaccination 
• 
Hypersensitivity to latex 
• 
Acute or chronic clinically significant abnormality or poorly controlled pre-existent 
co-morbidities or any other clinical conditions, as determined by physical 
examination or medical history that, in the opinion of the investigator, might pose 
additional risk to the participant due to participation in the study 
• 
Significant or uncontrolled psychiatric illness 
• 
Documented HIV-positive participant 
• 
Any clinically significant* hematological parameter and/or biochemical laboratory 
abnormality from the test requested by the investigator based on medical judgment 
prior to enrolment  
− 
*The investigator should use his/her clinical judgment to decide whether the test 
is needed, and which abnormalities are clinically significant. If he/she decides to 
run this test, the investigator will need to review the test results before 
proceeding with the administration of the study vaccine. See section 5.5 for 
more detail. 
• 
Lymphoproliferative disorder or malignancy within 5 years before study vaccination 
(excluding effectively treated non-melanoma skin cancer).  
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 the first doses (Day -29 to Day 1), or their planned use during the study 
period. 
• 
Planned administration/administration of a vaccine not foreseen by the study 
protocol within the period starting 30 days before the first dose and ending 30 days 
after the last dose of study intervention(s)* administration with the exception of any 
licensed influenza vaccine which may be administered ≥ 15 days before or after 
study vaccinations (dTpa and RSV maternal vaccines). 
− 
* In case emergency mass vaccination for an unforeseen public health threat 
(e.g. a pandemic) is organized by public health authorities outside the routine 

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immunization program, the time period described above can be reduced if 
necessary for that vaccine (if it is used according to the local governmental 
recommendations and that the Sponsor is notified accordingly). Therefore, 
COVID-19 vaccines will be allowed, when administered ≥ 15 days before or 
after study vaccinations (dTpa and RSV maternal vaccines). 
• 
Administration of long-acting immune-modifying drugs 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 3 months before the administration of the first dose of 
study intervention(s) or planned administration during the study period. 
• 
Chronic administration (defined as more than 14 days in total) of 
immunosuppressants or other immune-modifying drugs during the period starting 3 
months prior to the first study intervention dose(s) to 2 months after first vaccination. 
For corticosteroids, this will mean prednisone equivalent ≥ 5 mg/day for adult 
participants/ ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.  
• 
Previous experimental vaccination against RSV. 
• 
Boostrix (dTpa) administration for which the vaccination is not aligned with the 
local recommendations for dTap vaccination or not aligned with the locally approved 
Boostrix (dTpa) prescribing information. 
5.2.3. 
Prior/Concurrent clinical study experience 
• 
Concurrently participating in another clinical study, at any time during the study 
period, in which the participant has been or will be exposed to an investigational or a 
non-investigational intervention (drug/invasive medical device). 
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 
• 
Pregnant or lactating female 
• 
Female planning to become pregnant or planning to discontinue contraceptive 
precautions 
• 
Alcoholism or substance use disorder within the past 24 months based on the 
presence of two or more of the following abuse criteria: hazardous use, 
social/interpersonal problems related to use, neglected major roles to use, withdrawal 
tolerance, use of larger amounts or longer, repeated attempts to quit or control use, 
much time spent using, physical or psychological problems related to use, activities 
given up to use, craving (based on the DSM-5 criteria, [Hasin, 2013]); 
• 
Any study personnel or their immediate dependants, family, or household members 
• 
Child in care. Please refer to the Glossary of terms for the definition of child in care. 

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5.3. 
Lifestyle considerations 
No lifestyle considerations are necessary for this study. 
5.3.1. 
Demographic data 
Demographic data for participants including geographic ancestry (race)*, ethnicity*, 
month of birth (if allowed per local regulation) and year of birth, will be collected. 
*Differences in the safety and efficacy of certain medical products, including vaccines 
[Haralambieva, 2013; Kollmann, 2013; Pérez, 2009] have been observed in racially and 
ethnically distinct subgroups. These differences may be attributable to intrinsic factors 
(e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, environmental 
exposure, sociocultural issues), or interactions between these factors. Therefore, both 
geographic ancestry (race) and ethnicity will be collected for all study participants. 
5.3.2. 
Lifestyle characteristics 
Not applicable  
5.4. 
Screening failures 
Screen failures are participants who consent to take part in this study but are determined 
ineligible and not subsequently assigned to a study intervention. 
Limited data for screening failures (including reason for screening failure and any SAEs 
that occurred at the visit prior to vaccination) will be collected and reported in the eCRF.  
Note: Demography and required forms at Visit 1 should be completed for screening 
failures. 
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. Participants must be 
rescreened: 
• 
Participants with abnormal clinically significant* hematological/biochemical values 
at screening, and if expected to be temporary at the discretion of the investigator. 
− 
*The investigator should use his/her clinical judgment to decide which 
abnormalities are clinically significant. 
• 
Acute disease and/or fever at the time of enrollment. Refer to the SoA 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 vaccinated at the discretion of the 
investigator. 
• 
Use of systemic antibiotic or antiviral treatment within 48 hours prior to study 
vaccination. 

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6. 
STUDY INTERVENTION AND CONCOMITANT THERAPY 
Refer to the Glossary of terms for the definition of study intervention. Refer to the Study 
Procedures Manual (SPM) for additional details. 

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6.1. 
Study interventions administered (Amended 17 March 2022) 
Table 5 
Study interventions administered 
 
RSV maternal Vaccine* 
Boostrix (dTpa_500) 
Boostrix (dTpa_300)# 
Study intervention name:  
RSVPreF3  
NaCl Solution 
dTpa 
dTpa 
Study intervention Formulation 
RSVPreF3 (120 µg) 
Sodium Chloride 
(NaCl) (0.9%); Water 
for injections 
DT1 (≥ 2 IU); 
TT1 (≥ 20 IU); 
PT (8 µg)1; 
FHA (8 µg)1; 
PRN (2.5 µg)1; 
1adsorbed on Al(OH)3 (0.3 mg Al3+) and AlPO4 
(0.2 mg Al3+); 
Water for injections q.s. 0.5 mL 
DT1 (≥ 2 IU); 
TT1 (≥ 20 IU); 
PT (8 µg)1; 
FHA (8 µg)1; 
PRN (2.5 µg)1; 
1adsorbed on Al(OH)3 (0.3 mg Al3+); 
Water for injections q.s. 0.5 mL 
Presentation 
Powder for solution for injection (vial) 
Suspension for injection (syringe) 
Suspension for injection (syringe) 
Solution for solution for injection (syringe) 
Type 
Study 
Control 
Control 
Product Category 
Combination Product  
Combination Product  
Combination Product 
Route of administration: 
IM 
IM 
IM 
Location 
Arm 
Arm 
Arm 
Laterality ** 
non-dominant  
non-dominant  
non-dominant  
No of doses 
1 
1 
1 
Volume to be administered: 
whole content*** 
whole content**** 
whole content**** 
Side/site route 
IM/non-dominant arm 
IM/non-dominant arm 
IM/non-dominant arm 
Packaging, labelling 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 
GSK 
GSK  
* RSV maternal Vaccine=RSVPreF3  
** The non-dominant arm is the preferred arm of injection. In case it is not possible to administer the vaccine / product in the non-dominant arm, an injection in the dominant arm may be 
performed. 
*** The entire content of the pre-filled NaCl syringe will be transferred into the vial for reconstitution. The entire contents of the reconstituted vaccine/product will be withdrawn for 
administration. Refer to the SPM for more details. 
**** The entire content of the of the syringe will be administered. Refer to the SPM for more detail. 
#This dose form of Boostrix is not applicable in the study anymore as no non-US sites were initiated before the decision to stop the study. 
 

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Study participants must be observed closely for at least 30 minutes after the 
administration of the study intervention(s). Appropriate medical treatment must be 
readily available during the observation period in case of anaphylaxis, syncope.  
6.2. 
Preparation, handling, storage, and accountability 
The study intervention(s) 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(s). 
Storage conditions will be assessed by a sponsor study contact during pre-study activities. 
Refer to the Study Procedures Manual (SPM) for more details on storage and handling of 
the study intervention(s) 
6.3. 
Measures to minimise bias: randomisation and blinding 
(Amended 17 March 2022) 
6.3.1. 
Participant identification 
Each participating country and site will have a range of participant identification number 
and enrolled subjects will be assigned to those numbers sequentially. 
6.3.2. 
Randomisation to study intervention 
A total of 252 participants will be enrolled evenly in 2 age groups, (9-17 YOA and 18-49 
YOA). Within each age group, approximately 126 participants will be 1:1 randomized 
either receiving RSV maternal vaccine followed by dTpa vaccine 30 days later or 
receiving dTpa vaccine followed by RSV maternal vaccine 30 days later. Study is 
stopped after enrolling 8 subjects (7 adult and one adolescent) hence no more 
randomization and intervention will be applicable. 
6.3.3. 
Intervention allocation to the participant 
The randomization algorithm will use a stratification procedure accounting for 
participants age at the time of study intervention administration (9-17 YOA, 18-49 YOA) 
and a minimization procedure accounting for (a) Center and (b) Study. Minimization 
factors will have equal weight in the minimization algorithm. 
Once a participant identification number is allocated, the randomisation system will 
determine study group and will provide the study intervention number to be used for the 
first dose. The study intervention number(s) to be used for subsequent dosing will be 
provided by the same automated Internet-based system (SBIR) 
When an automated, Internet-based system (SBIR) is not available, please refer to the 
SBIR user guide or SPM for specific instructions. 
Refer to the SPM for additional information about the study intervention number 
allocation. 

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6.3.4. 
Allocation of participants to assay subsets 
Not applicable 
6.3.5. 
Blinding and unblinding 
This is an open-label study; however, an electronic system will be used for allocation of 
treatment numbers. Potential bias will be reduced by the using the allocation system on 
the internet and adjudications 
The laboratory in charge of sample testing will be blinded to the study intervention 
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. 
6.3.5.1. 
Emergency unblinding 
Not applicable since this is an unblinded study 
6.4. 
Study intervention compliance 
When the study intervention is administered at the site, participants will receive it directly 
from the investigator or designee, under medical supervision. The date of administration 
of each study intervention dose in the clinic will be recorded in the source documents. 
The intervention number administered, and the administration date and time will be 
recorded in the source documents. 
6.5. 
Dose modification 
Section is not applicable. 
6.6. 
Continued access to study intervention after the end of the 
study 
Not applicable 
6.7. 
Treatment of overdose 
Not applicable 
6.8. 
Concomitant therapy 
At each study visit/contact, the investigator or his/her delegate should question the 
participant and/or the participant’s parent(s)/LAR(s) about all medications/products 
taken, and vaccinations received by the participant. 

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The following concomitant medication(s)/product(s)/vaccine(s) must be recorded in the 
eCRF: 
• 
All concomitant medication associated with an adverse event, including 
vaccines/products, except vitamins and dietary supplements, administered after the 
study intervention until the end of the study.  
• 
All concomitant medication leading to discontinuation of the study intervention or 
elimination from the analysis, including products/vaccines. Please refer to the 
sections 5.2 and 9.2.1 for further details. 
• 
Any concomitant medications/products/vaccines listed in Section 5.2.2 during the 
period specified in that section. 
• 
All concomitant medication which may explain/cause/be used to treat an SAE 
including vaccines/products, as defined in Sections 8.3.1 and 10.3.8. These must also 
be recorded in the Expedited Adverse Event report. 
• 
Prophylactic medication related to the effects (actual or anticipated) of study 
vaccine/product administration (e.g., medication administered either in the absence 
of ANY symptom and in anticipation of a reaction to the study vaccine, or to prevent 
re-occurrence of one or more post-vaccination AEs such as headache). 
The Local Medical Lead (LML) 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 
‘Discontinuation’ of study intervention refers to any participant who has not received all 
planned doses of study intervention. A participant who discontinued study intervention 
may continue other study procedures (e.g. safety or immunogenicity), planned in the 
study protocol at the discretion of the investigator.  
The primary reason for premature discontinuation of the study intervention will be 
documented on the eCRF as follows: 
• 
Adverse event requiring expedited reporting to GSK 
• 
Unsolicited non-serious adverse event  
• 
Solicited adverse event 
• 
Not willing to be vaccinated 
• 
Other (specify). 
7.1.1. 
Contraindications to subsequent study intervention(s) 
administration 
Contraindications of study interventions do not apply since this is a single (experimental) 
dose study.  

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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 did not 
return for the concluding visit 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 
• 
Unsolicited non-serious adverse events 
• 
Solicited adverse event 
• 
Withdrawal by participant, not due to an adverse event* 
• 
Migrated/Moved from the study area 
• 
Lost to follow-up 
• 
Sponsor study termination 
• 
Other (specify) 
*If a participant is withdrawn from the study because she/the participant’s 
parent(s)/LAR(s) 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 10.3.8.2). 
7.3. 
Lost to follow-up 
A participant will be considered ‘lost to follow-up’ if 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 summarised in the SoA (Section 1.3).  
All screening evaluations must be completed and the results reviewed before confirming 
that potential participants meet all eligibility criteria.  
The investigator will maintain a log of all participants screened. All relevant information, 
such as confirmation of eligibility and reasons for screening failure will be mentioned in 
this screening log. 
Procedures conducted as part of routine clinical management (e.g. hematologic profiles), 
and obtained before the participant/participant’s parent(s)/LAR(s) signed the Informed 
Consent Form (ICF), may be used for screening and/or for establishing a clinical baseline 
(provided the procedure met protocol specified criteria and was performed within the 
time frame defined 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. 
Study Procedures During Special Circumstances 
• 
During special circumstances (e.g., the COVID-19 pandemic), the specific guidance 
from local public health and other competent authorities regarding the protection of 
individuals’ welfare must be applied. Please refer to the SPM for details. 
For the duration of such special circumstances, the following measures may be 
implemented for enrolled participants: 
• 
Enrollment of additional participants may be placed on hold. Decisions on re-starting 
enrollment to achieve the planned sample size will be made in a manner consistent 
with guidance from public health and other competent authorities. 
• 
The following measures may be implemented for enrolled participants: 
− 
If it is not possible to conduct a protocol-specified, scheduled or event-driven 
visit as described in Section 1.3 the visit may be replaced with a contact 
conducted by SMS, email, telephone, videotelephony or telemedicine. In such 
cases: 
− 
Protocol-specified clinical data that 
− 
cannot be collected by study staff during the contact (e.g., physical 
examination results) BUT 

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− 
are available within the allowed interval (Table 2) in the participant’s 
medical records and can be obtained by site staff (as allowed by local 
law), may be recorded in the participant’s source document and entered 
into the eCRF. 
− 
Whenever possible, as appropriate per the judgment of the investigator and as 
allowed by local law, arrangements should be made for qualified personnel to 
collect any protocol-specified safety data, safety assessment(s), and/or biological 
samples at an alternate location* within the visit interval (Table 2). 
− 
Samples should not be collected if they cannot be processed in a timely 
manner and / or appropriately stored until the intended use. 
− 
Blood samples for central assessment must be collected using GSK-
provided supplies. 
− 
“Medically attended visits” will include instances where, due to the special 
circumstances, the participant cannot seek medical advice for symptoms/an 
illness by visiting a medical facility or arranging for a home visit, and seeks this 
advice instead via telephone, SMS, email, videotelephony or telemedicine, or 
other means. 
Additional details of how these visits can be conducted are outlined in the SPM. 
Impact on the analysis sets for immunogenicity will be determined on a case by case 
basis. 
*It is the investigator’s responsibility to identify an alternate location. The investigator 
should ensure that this alternate location meets 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. 
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 participant to prior 
IEC/IRB approval, if required by local legislation. 
Information on further research and its rationale can be obtained from GSK. 
Sample testing will be done in accordance with the recorded consent of the individual 
participant/participant’s parent(s)/LAR(s).  

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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 (Amended 17 March 2022) 
Please refer to the central laboratory manual for details on biospecimen management 
(handling, storage and shipment). 
Table 6 
Biological samples 
Sample type 
Collected to 
Evaluate* 
Time point  
(RSV_dTpa-P, 
RSV_dTpa-A) 
Minimum 
Quantity per 
participant 
Unit 
Additional Information 
Whole blood for 
immune response 
Visit 1 (Day 1) 
~5 
mL 
Immune response: 5 mL (~ 2 mL 
serum). 
Whole blood for 
immune response 
Visit 2 (Day 31) 
~5 
mL 
Immune response: 5 mL (~ 2 mL 
serum).  
 
 
~10 
mL 
Urine for 
Pregnancy** 
Visit 1 (Day 1) and 
Visit 2 (Day 31) 
 
*The blood sample to be taken for immune response must be taken before administering the study intervention. 
**Urine sample was collected for all subjects at Visit 1. At Visit 2, urine sample will only be collected for study 
participants enrolled in RSV dTpa-P and RSV dTpa-A groups. 
8.1.2. 
Laboratory assays (Amended 17 March 2022) 
All laboratory testing will be performed at GSK laboratory or in a laboratory designated 
by GSK.  
Table 7 
Laboratory assays  
*NEU=Neutralization Assay; ELI=ELISA or enzyme-linked immunosorbent assay 
** for participants receiving RSV maternal vaccine at Visit 1 
*** Visit 2(Day 31 prior to immunization) is no more applicable after the study stop 
Sampling time 
points 
System 
Component 
Method* 
Groups 
Laboratory 
Visit 1** 
(Day 1  
prior to 
immunization) 
Serum 
Respiratory Syncytial Virus 
A Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
B Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A 
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
PreF3 Ab.IgG 
concentration 
ELI 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Visit 2*** 
(Day 31 
prior to 
immunization) 
Serum 
Respiratory Syncytial Virus 
A Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
B Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A 
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
PreF3 Ab.IgG 
concentration 
ELI 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 

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The addresses of clinical laboratories used for sample analysis are provided in a separate 
document accompanying this study protocol. 
GSK clinical laboratories have established a Quality System supported by procedures. 
The activities of GSK clinical laboratories are audited regularly for quality assessment by 
an internal (sponsor-dependent) but laboratory-independent Quality Department. 
8.1.3. 
Immunological read-outs (Amended 17 March 2022) 
The following readouts are applicable to only 8 participants enrolled in the study. 
Table 8 
Immunological read-outs  
Blood sampling timepoint 
Approximate No. 
participants 
Component 
Type of 
contact and 
timepoint 
Sampling 
timepoint 
Visit 1* (Day 1) 
pre- 1st 
vaccination 
126 
Respiratory Syncytial Virus A Ab neutralizing 
126 
Respiratory Syncytial Virus B Ab neutralizing 
126 
Respiratory Syncytial Virus PreF3 Ab.IgG concentration 
Visit 2 (Day 31) post 1st 
vaccination 
252 
Respiratory Syncytial Virus A Ab neutralizing 
252 
Respiratory Syncytial Virus B Ab neutralizing 
252 
Respiratory Syncytial Virus PreF3 Ab.IgG concentration 
* for participants receiving RSV maternal vaccine at Visit 1 
8.1.4. 
Immunological correlates of protection 
8.1.4.1. 
RSV Maternal Vaccine 
No generally accepted immunological correlate of protection has been demonstrated so 
far for the antigen(s) used in the RSV maternal vaccine. 
8.1.4.2. 
Boostrix 
For this study, no assays will be performed for immunogenicity assessment of Boostrix 
antigens.  
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. 
8.2.1. 
Pre-intervention administration procedures 
Obtain the participant’s medical/vaccination history by interviewing her and/or reviewing 
her medical records. Record any pre-existing participant conditions, signs and/or 
symptoms present prior to the study vaccination in the eCRF. 

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8.2.1.1. 
Collection of demographic data 
Demographic data such as date of birth, sex, childbearing potential, race and ethnicity 
will be recorded in the participant’s eCRF. 
8.2.1.2. 
Medical/vaccination history 
Obtain the participant’s medical/vaccination history by interviewing the 
participant/parent(s)/LAR(s) and/or review of the participant’s medical records. Record 
any pre-existing conditions, signs and/or symptoms present prior to the study intervention 
in the eCRF. All prior therapy including hematological products (e.g. plasma transfusion, 
blood transfusion etc.), medications, and vaccines received by the participant in the last 
30 days prior to study start should be collected and recorded. In case of seasonal flu 
and/or COVID-19 vaccine administration, this information is applicable ≥ 15 days before 
or after study vaccinations. dTpa vaccine history must be collected and recorded for the 
last 10 years. 
8.2.1.3. 
History directed physical examination 
Perform a full physical examination of the participant at the Visit 1 (Day 1) and Visit 2 
(Day 31), including assessment of oral (preferred)/axillary body temperature and resting 
vital signs: systolic/diastolic blood pressure, heart rate and respiratory rate after at least 
10 minutes of rest. 
8.2.1.4. 
Pregnancy test (Amended 17 March 2022) 
Female participants (9 to 49 YOA) of childbearing potential as well as pre-menarche girls 
must perform a urine pregnancy test before the administration of any dose of study 
intervention (dTpa or RSV maternal vaccine). Pregnancy testing must be done even if the 
participant is menstruating at the time of the study visit. The study intervention may only 
be administered if the pregnancy test is negative.  
A serum pregnancy test may be performed (instead of a urine pregnancy test) if required 
by country, local or ethics committee regulations. 
Urine for pregnancy test during the Visit 2 will still be performed for subjects who have 
received RSV maternal vaccine in their first visit.  
Refer to Section 10.4.3.1 for the information on study continuation for participants who 
become pregnant during the study. 
8.2.1.5. 
Warnings and precautions to administration of study intervention 
Warnings and precautions to administration of study intervention must be checked at 
each visit with planned administration of study intervention. 
8.2.2. 
Clinical safety laboratory tests 
Not applicable for this study. 

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8.2.3. 
Study holding rules and safety monitoring 
An internal SRT and external IDMC (external to GSK) will review the safety data on a 
regular basis throughout the study. Any potential safety concern identified will be 
escalated to the GSK Vaccine Safety Monitoring Board (VSMB). 
8.2.3.1. 
Safety evaluation by the Safety Review Team  
The SRT includes as core members the GSK’ Central Safety physician, Safety scientist, 
Clinical Research & Development Lead (CRDL), Epidemiologist, Global Regulatory 
Lead and Biostatistician of the project. The SRT is responsible for ongoing safety 
monitoring of the entire study, reviewing the unblinded safety data on a regular, ongoing 
basis. The SRT will inform the IDMC about any potential safety concern at any point 
during the study and may request ad-hoc safety evaluations by the IDMC.  
8.2.3.2. 
Independent Data Monitoring Committee Evaluation 
An unblinded IDMC will be established by GSK. The IDMC will monitor the safety data 
and the scientific validity of the study. The IDMC and SRT will review safety data (as 
clean as possible) on an ongoing basis. Additional details concerning the IDMC’s 
structure and processes will be provided in the IDMC charter. 
8.2.3.3. 
Study holding rules 
The safety holding rules are defined in Table 9. Holding rules 1a-b will be assessed by 
the investigator on a continuous basis. 
Table 9 
Study holding rules 
Holding 
Rule 
Event 
Number of 
participants 
1a 
Any death within 30 days from study dose administration of the interventions (RSV 
maternal vaccine and dTpa) that cannot be reasonably attributed to a cause other 
than vaccination as per Investigator assessment  
≥ 1 
1b 
Any life-threatening SAE within 30 days from study dose administration of the 
interventions (RSV maternal vaccine and dTpa) that cannot be reasonably attributed 
to a cause other than vaccination as per Investigator assessment 
≥ 1 
The following communication sequence must be followed: 
If at any time, there is a safety concern identified by the SRT or if a holding rule is met, a 
hold on study dose administration can be implemented pending further investigation. 
Table 9 presents the safety holding rules 1 (a-b) to be assessed by the investigator on an 
ongoing basis. Meeting a holding rule will trigger a hold of study intervention 
administration irrespective of number of participants enrolled and/or timing of the event 
relative to study dose administration. While vaccinations are on hold, the investigator 
should not consent subjects into the study. 

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If the investigator becomes aware of a holding rule being met, he/she must suspend 
administration of the study intervention and inform GSK immediately and enter the data 
in the electronic case report form (eCRF). (e.g. holding rules 1a-b). Refer to Table 12 for 
contact information. It is Sponsor’s responsibility to put the enrolment or the study 
intervention administration on hold at all centers. The IDMC will be informed once a 
holding rule is met. 
GSK will inform all investigators if holding rules 1a-b are met. 
Additional safety data, if required, will also be reviewed by the IDMC to allow for an 
overall assessment of the benefit/risk profile of vaccination. The IDMC may recommend 
that the study be placed on hold for reasons not covered by the holding rules if deemed 
necessary. 
8.3. 
Adverse Events (AEs), Serious Adverse Events (SAEs) and 
other safety reporting 
8.3.1. 
Time period and frequency for collecting AE, SAE and other 
safety information 
An overview of the protocol required reporting periods for AEs, SAEs, and pregnancies 
is given in Table 10. 
Table 10 
Timeframes for collecting and reporting of safety information 
(Amended 17 March 2022) 
Event 
V1 
 
C1 
 
V2 
Contact 2  
D1 D7 D8 D30 D31 
180 days post RSV 
vaccination*** 
Solicited administration site event and systemic 
AEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unsolicited AEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AEs leading to withdrawal from the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAEs* 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MAEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancies 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. V=Visit; D=Day; C=Contact 
* SAEs related to study participation or concurrent GSK medication/vaccine will be monitored from the time of 
screening to the time of the immunization. Both will be conducted on the same visit. 
*** For all study groups at Day 181 

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The investigator or designee will record and immediately report all SAEs in enrolled 
participants to the sponsor or designee via the Expedited AE Reporting Form. Reporting 
should, under no circumstances, occur later than 24 hours after the investigator becomes 
aware of an SAE, as indicated in Section 10.3.10. The investigator will submit any 
updated SAE data to the sponsor within 24 hours of it being available.  
A post-study AE/SAE is defined as any event that occurs outside of the AE/SAE 
reporting periods defined in Table 10. Investigators are not obligated to actively seek AEs 
or SAEs from former study participants. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has been discharged from the study, and 
he/she considers the event to be reasonably related to the study intervention, the 
investigator will promptly notify the study contact for reporting SAEs mentioned in the 
Table 12. 
8.3.2. 
Method of detecting AEs and SAEs, pregnancies and other 
events 
Detection and recording of AE/SAE/pregnancies are detailed in Section 10.3.8.  
Assessment of AE/SAE intensity, causality and outcome are described in Section 10.3.9.  
Open-ended and non-leading verbal questioning of participants/participants’ 
parent(s)/LAR(s) is the preferred method of acquiring information related to an 
AE/SAE/pregnancy. 
8.3.3. 
Regulatory reporting requirements for SAEs, pregnancies and 
other events 
Once an investigator (or designee) becomes aware that a study participant has 
experienced an SAE/pregnancy, it must be reported to GSK using the required 
documentation and within the timeframes mentioned in Table 11. 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 the investigator must always provide an assessment of causality at the time of 
the initial report, as defined in the Section 10.3.9.2. 
Local regulatory requirements and sponsor policy for preparation of an investigator 
safety report of Suspected Unexpected Serious Adverse Reactions (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 10.3.10 for further details regarding the reporting of 
SAEs/pregnancies. 

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Table 11 
Timeframes for submitting SAE, pregnancy 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 
Pregnancies 
24 hours* 
electronic pregnancy report 
24 hours* 
electronic pregnancy report 
* Timeframe allowed after receipt or awareness of the information by the investigator/site staff. 
‡ Paper Expedited Adverse Events Report will be dated and signed by the investigator (or designee). 
‡‡ The investigator will be required to confirm review of the SAE causality by ticking the ‘reviewed’ box in the electronic 
Expedited Adverse Events Report within 72 hours of submission of the SAE. 
8.3.3.1. 
Contact information for reporting SAEs, pregnancies and study holding 
rules 
Table 12 
Contact information for reporting SAEs, pregnancies and study 
holding rules 
Study contact for questions regarding 
SAEs, pregnancies 
Study contact for reporting of study 
holding rules  
Refer to the local study contact 
information document 
As soon as the investigator is aware that a 
holding rule is met, he/she must 
immediately inform the Local Medical 
Lead (LML).  
Back up study contact for reporting 
SAEs, pregnancies 
Available 24/24 hours and 7/7 days: 
Back up study contact for escalation of 
holding rules  
Refer to the local study contact 
information document. 
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 administered for the treatment of an SAE should be recorded in the 
Expedited Adverse Event Report of the participant’s eCRF screen (refer to Section 
10.3.10.1). 

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8.3.5. 
COVID-19 Infection 
COVID-19 cases identified during the study (as per standard of care) will be captured and 
reported using standard AE or SAE criteria, as outlined in Section 10.2. 
COVID-19 cases should be reported in the eCRF according to the WHO Case Definition, 
[WHO, 2020] using one of the following terms: 
• 
Suspected COVID-19 infection 
• 
Probable COVID-19 infection 
• 
Confirmed COVID-19 infection 
8.3.6. 
Participant card 
The investigator (or designee) must provide the participant/participant’s parent(s)/LAR(s) 
with a “participant card” containing information about the clinical study. The 
participant/participant’s parent(s)/LAR(s) must be instructed to always keep the 
participant card in his/her/their possession for the duration of the study. In an emergency, 
this card serves to inform the responsible attending physician/LAR/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. 
8.3.7. 
Medical device deficiencies 
The study intervention is a combination product constituted of a device and biologic 
product (e.g. pre-filled syringes). Refer to the Section 10.6.1 for the definition of 
combination product and medical device deficiency. 
8.3.7.1. 
Detection, follow-up and prompt reporting of medical device deficiency 
The investigator is responsible for the detection, documentation and prompt reporting of 
any medical device deficiency occurring during the study to GSK. This applies to any 
medical device provided for the conduct of the study. 
Device deficiencies will be reported to GSK within 24 hours after the investigator 
determines that the event meets the protocol definition of a device deficiency. Refer to 
Section 10.6.1 for definitions and details on recording and reporting of these events. 
The investigator will ensure that follow-up includes any additional investigations to 
elucidate the nature and/or related of the device deficiency to the incident. Follow-up 
applies to all participants, including those who discontinue study intervention or the 
study. 
New or updated information will be recorded on the originally completed form with all 
changes signed and dated by the investigator and reported to GSK within 24 hours. 

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8.3.7.2. 
Regulatory reporting of medical device deficiency when used as 
combination product 
The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study to GSK. GSK has a legal responsibility to notify 
appropriate regulatory authorities and other entities about safety information linked to 
medical devices being used in clinical studies. Refer to section 10.6 for details of 
reporting. 
The investigator, or responsible person according to local requirements (e.g. the head of 
the medical institution), will comply with the applicable local regulatory requirements 
relating to the reporting of device deficiencies to the IRB/IEC. 
8.4. 
Pharmacokinetics 
Not applicable  
8.5. 
Genetics  
Not applicable  
8.6. 
Biomarkers 
Not applicable  
8.7. 
Immunogenicity assessments 
Immunogenicity is described in Section 8.1 and Section 9.3.2.1. 
8.8. 
Health outcomes 
Not applicable 
9. 
STATISTICAL CONSIDERATIONS (AMENDED 17 
MARCH 2022) 
This section will not be applicable as the study has been stopped. However only 
descriptive statistics will be provided for immunogenicity, safety and reactogenicity at 
an individual level. 
9.1. 
Statistical hypotheses 
No hypothesis test will be performed. All analyses will be descriptive. 

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9.2. 
Analysis sets 
Table 13 
Analysis sets 
Analysis set 
Description 
Enrolled  
All participants who completed the informed consent process and signed the 
informed consent form. 
Exposed  
All participants who received the study intervention (RSV maternal vaccine or 
dTpa). Analysis per group using the Exposed Set is based on the administered 
intervention. 
Full Analysis -
Immunogenicity 
All participants who received at least 1 dose of the study intervention (RSV 
maternal vaccine) and have post-vaccination immunogenicity data. 
Per Protocol -
Immunogenicity 
All participants in the Full Analysis set (Immunogenicity) who received RSV 
maternal vaccine to which they were randomized minus participants with protocol 
deviations that lead to exclusion. 
Unsolicited Safety  
All participants in the Exposed Set that report unsolicited AEs/report not having 
unsolicited AEs 
Solicited Safety  
All participants in the Exposed Set who have solicited safety data 
9.2.1. 
Criteria for elimination from analysis 
If the participant meets one of the criteria mentioned below or ones listed in the Section 
7.1.1, she may be eliminated from per protocol analysis. 
If the participant has a protocol deviation deemed as major, she may be eliminated from 
the per protocol analysis sets. 
Major protocol deviations leading to exclusion will be defined in the Statistical Analysis 
Plan (SAP) and will be finalized prior to the first analysis. 
Key major deviations include, but are not limited to, the following: 
• 
Participants enrolled who did not meet entry criteria including age at enrollment  
• 
Participants incorrectly vaccinated  
• 
Participants who did not receive study vaccinations as planned in protocol  
• 
Participants who did not have blood draws as planned in protocol  
• 
Participants with a blood draw outside of allowed time window 
9.3. 
Statistical analyses 
9.3.1. 
Primary endpoint(s)/estimand(s) analysis 
9.3.1.1. 
Safety  
All safety analyses will be performed on the Solicited Safety, Unsolicited Safety and 
Exposed sets. Safety endpoints including solicited AEs, unsolicited AEs, SAEs, AEs 
leading to study termination will be descriptively summarized. Numbers of participants 
reporting above AEs will be reported. 

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Primary Safety Endpoints  
Statistical Analysis Methods 
Pediatric and 
Adult 
participants 
The number of participants in each 
study group reporting Each solicited 
administration site event collected 
during the 7 days follow-up period 
post Dose 1 (Day 1 to Day 7 post 
intervention including day of 
vaccination) 
• 
Each solicited systemic 
event collected during the 
7 days follow-up period 
post Dose 1 
• 
Each unsolicited AE 
collected during the 30 
days follow-up period 
post Dose 1 
• 
SAEs/MAES collected 
during the 30 days follow-
up period post Dose 1 
• 
AEs/SAEs leading to 
study withdrawal for the 
30 days follow-up period 
post Dose 1  
The number of adult and pediatric participants reporting 
each solicited administration site event (any grade, each 
grade) and solicited systemic event (any, each grade) 
during the 7-day (Day 1 to Day 7 post intervention including 
day of vaccination) follow-up period after dosing will be 
tabulated by maximum intensity per participant for each 
study group.  
The number of participants reporting: 
• 
at least one administration site AE (solicited) 
• 
at least one systemic AE (solicited) 
during the 7-day follow-up period after dosing will be 
tabulated .  
The number and percentage of participants reporting: 
• 
at least one AE (unsolicited)  
• 
at least one SAE/MAE 
• 
at least one AE/SAE leading to study withdrawal 
during the 30-days post Dose 1 follow-up period after 
dosing will be tabulated .  
The same computations will be done for Grade 3 solicited 
and unsolicited AEs, for any AEs considered related to 
vaccination, for any Grade 3 AEs considered related to 
vaccination and for any AEs resulting in a medically 
attended visit (i.e., MAEs). 
The number of participants in 
each study group reporting  
• 
SAEs during the entire 
study period. 
AEs/SAEs leading to study 
withdrawal during the entire 
study period. 
The number of both the pediatric and adult participants 
reporting: 
• 
at least one SAE 
• 
at least one (S)AE leading to study withdrawal 
during the entire study period will be tabulated 
by group/doses and by MedDRA preferred term. 
By participant listings of SAEs, (S)AEs leading to study 
withdrawal and MAEs will be prepared, but will not be 
released until the final, unblinded, analysis has been 
completed. 

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9.3.2. 
Secondary endpoint(s)/estimand(s) analyses 
9.3.2.1. 
Immunogenicity 
 
Secondary Immunogenicity 
Endpoints 
Statistical Analysis Methods 
Pediatric 
and Adult 
participants 
RSV A neutralizing antibody titers 
at pre-dosing and Day 31 post 
RSV maternal vaccine 
administration 
For RSV A neutralizing antibody titers at pre- dosing 
and Day 31 post RSV maternal vaccine administration :  
• 
Antibody titers/concentrations will be displayed 
using reverse cumulative curves. 
• 
Individual antibody titers at pre-dosing and Day 
31 will be listed. 
• 
Individual post-dosing versus pre-dosing results 
will be plotted using scatter plots. 
• 
Individual fold increase of antibody titers at Day 
31 post RSV maternal vaccine administration over 
pre-dosing will be tabulated . 
▪ 
RSV B Neutralizing Ab titers 
and RSVPreF3 IgG ELISA 
concentration at pre-dose, Day 
31 post RSV maternal vaccine 
administration. 
For each assay, at each timepoint:  
Antibody concentrations/titers will be displayed using 
reverse cumulative curves. 
• 
Individual antibody titers/concentrations at pre-dosing 
and Day 31 will be listed 
• 
Individual post-dosing versus pre-dosing results will 
be plotted using scatter plots.  
• 
Individual fold increase of antibody 
titers/concentrations at each post-dosing timepoint 
over pre-dosing will be tabulated. 
Relationship between RSVPreF3 IgG-specific antibody 
concentration, RSV A neutralizing antibody, and RSV B 
neutralizing antibody at baseline and each post RSV 
maternal vaccine administration timepoint will be explored 
using scatter plots of individual values. 
9.4. 
Conduct of analyses  
No interim analyses are planned.  
9.4.1. 
Sequence of analyses 
• 
The final analysis will be performed when all data up to study end are available. A 
clinical study report including all available data will be written and made available to 
the investigators at that time. 
The details of the statistical analysis will be presented in the protocol and the statistical 
analysis plan. 

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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 Organisations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
− 
Applicable ICH Good Clinical Practice (GCP) Guidelines 
− 
Applicable laws and regulations 
• 
The protocol, protocol amendments, ICF, Informed Assent Form (IAF), 
Investigator’s Brochure, 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/participant’s parent(s) or his/her LAR(s) and answer all questions regarding 
the study.  
Participants/participants’ parent(s)/LAR(s) must be informed that their participation is 
voluntary.  
Freely given and written/witnessed/thumb printed informed consent must be obtained 
from each participant and/or each participant’s parent(s)/LAR(s)/witness and participant 
informed assent, 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 centre. 
The medical record must include a statement that written or witnessed/thumb printed 
informed consent was obtained before the participant was enrolled in the study and the 
date the consent was obtained. The authorised 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/participants’ parent(s)/LAR(s).  
Re-consent must be obtained in accordance with local laws and regulations for 
participants who become legally emancipated during the study, i.e. reach the legal age of 
consent. The participant can provide consent by signing/witnessing/thumb printing an 
ICF, similar to that provided to the parent(s)/LAR(s) at study start, which summarises the 
study and includes a consent statement and documents that the participant agrees to 
continue participating in the study. 
The study investigator is encouraged to obtain assent from the minor in addition to the 
consent provided by the LAR(s) when a minor can assent to decisions about his/her 
participation in a study. The investigator is also accountable for determining a minor's 
capacity to assent to participation in a research study according to the local laws and 
regulations. 
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.  

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The participants/participants’ parent(s)/LAR(s) must be informed that: 
• 
His/her personal/their child’s study-related data will be used by the sponsor in 
accordance with local data protection law.  
• 
 His/her medical records/their child’s may be examined by Clinical Quality 
Assurance auditors or other authorised 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/participants’ parent(s)/LAR(s) 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 
Safety oversight will be provided by an SRT composed of GSK RSV team members and 
also by an IDMC. 
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. 

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10.1.7. 
Data quality assurance 
The investigator should maintain a record of the location(s) of their respective essential 
documents, including 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, CRF), the copy should fulfil the 
requirements for certified copies. 
All participant data related to the study will be recorded on printed or electronic CRF 
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. 
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 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. 
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 Study Management Plan 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 Clinical 
Study Report (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.  

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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. 
10.1.9. 
Study and site start and closure 
First act of recruitment 
The study start date is the date on which the first subject is enrolled/ randomized and is 
considered the first act of enrollment. 
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 
organisation(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. 

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At the end of the study, the investigator will: 
• Review data collected to ensure accuracy and completeness 
• Complete the study conclusion screen in the eCRF 
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 Last Subject Last Visit (LSLV) for 
interventional studies and follows the guidance from the International Committee of 
Medical Journal Editors (ICMJE). 
10.2. 
Appendix 2: Clinical laboratory tests 
10.2.1. 
Descriptions of the assays to be performed in the study 
Assay descriptions could be subject to change, due to assay re-development and/or 
qualification. 
RSV-A and RSV-B neutralization assays  
The RSV-A and RSV-B neutralization assays are functional assays that measure the 
ability of serum antibodies to neutralize RSV entry and replication in a host cell line. 
Virus neutralization is performed by incubating a fixed amount of RSV with serial 
dilutions of the test serum. Then, the serum-virus mixture is transferred onto a Vero cells 
culture and incubated for two days to allow infection of Vero cells. Thereafter, RSV-
infected cells are detected by the visualization of the number of plaques.  
RSVPreF3 IgG ELISA  
The ELISA assay is based on an indirect ELISA allowing the detection and the 
quantification of specific IgG antibodies directed against RSVPreF3 in human serum 
samples and related to reference standard. The optical density of each sample dilution is 
then interpolated on the reference standard. The corresponding antibody concentration, 
corrected for the dilution factor, is expressed in arbitrary ELISA Laboratory Units per 
milliliter (ELU/mL). 

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10.3. 
Appendix 3: Adverse Events: definitions and procedures for 
recording, evaluating, follow-up, and reporting  
10.3.1. 
Definition of an Adverse Event (AE)  
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including 
an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical 
study participant that is temporally associated with the study intervention. The AE may or 
may not be considered related to the study intervention. 
10.3.1.1. 
Events Meeting the AE Definition  
• 
Significant or unexpected worsening or exacerbation of the condition/indication 
under study. 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after administration of the study 
intervention even though they may have been present before study start. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug, disease or other 
interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either the 
study intervention or a concurrent medication. 
• 
Signs or symptoms temporally associated with administration of the study 
intervention. 
• 
Signs, symptoms that require medical attention (e.g. hospital stays, physician visits 
and emergency room visits) 
• 
Significant failure of an expected pharmacologic or biological action. 
• 
Pre- or post- intervention events that occur as a result of protocol-mandated 
procedures (i.e. invasive procedures, modification of participant’s previous 
therapeutic regimen). 
• 
Clinically significant abnormal laboratory findings or other abnormal assessments 
that are present at baseline and significantly worsen following the start of the study 
will also be reported as AEs or SAEs. 
• 
AEs to be recorded as solicited AEs are described in the Section 10.3.3. All other 
AEs will be recorded as UNSOLICITED AEs. 
• 
The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will 
be reported as AE or SAE if they fulfil the definition of an AE or SAE. 

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10.3.1.2. 
Events NOT Meeting the AE Definition 
• 
Situations where an untoward medical occurrence did not occur (e.g. social and/or 
convenience admission to a hospital, admission for routine examination). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.  
• 
Pre-existing conditions or signs and/or symptoms present in a participant before 
the study intervention. These events will be recorded in the medical history section 
of the eCRF.  
• 
Hospitalisation for elective treatment of a pre-existing condition (known or 
diagnosed before signing the informed consent) that did not worsen from baseline. 
• 
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
10.3.2. 
Definition of an SAE 
An SAE is any untoward medical occurrence that: 
a. 
Results in death 
b. Is life-threatening 
Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in 
which the participant was at risk of death at the time of the event. It does not refer 
to an event, which hypothetically might have caused death, had it been more 
severe. 
c. 
Requires hospitalisation or prolongation of existing hospitalisation 
Note: In general, hospitalisation signifies that the participant has been admitted 
(usually involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any 
other serious criteria, the event is serious. When in doubt as to whether 
“hospitalisation” occurred or was necessary, the AE should be considered serious. 
d. Results in disability/incapacity  
Note: The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. This definition is not intended to include 
experiences of relatively minor medical significance such as uncomplicated 
headache, nausea, vomiting, diarrhoea, 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 

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f. 
Abnormal pregnancy outcomes (e.g. spontaneous abortion, foetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) 
g. Other situations 
Medical or scientific judgement 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 hospitalisation but may 
jeopardise the participant or require medical or surgical intervention to prevent one 
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 hospitalisation. 
10.3.3. 
Solicited events 
a. 
Solicited administration site events 
The following administration site events will be solicited: 
Table 14 
Solicited administration site events 
All age groups 
Pain  
Redness  
Swelling  
b. Solicited systemic events 
The following systemic events will be solicited: 
Table 15 
Solicited systemic events 
Fever 
Headache 
GI Symptoms (Nausea, Vomiting, Diarrhea, Abdominal 
pain) * 
Fatigue 
* Nausea, vomiting, diarrhea and abdominal pain are collected individually. 
Note: participants/participants’ parent(s)/LAR(s) will be instructed to measure and record 
the axillary or oral temperature in the evening. If additional temperature measurements 
are taken at other times of the day, participants/participants’ parent(s)/LAR(s) will be 
instructed to record the highest temperature in the e-diary. 
10.3.4. 
Unsolicited adverse events 
An unsolicited adverse event is an adverse event that was not included in a list of 
solicited events using a Participant Diary. Unsolicited events must have been 
spontaneously communicated by a participant/participant’s parent(s)/LAR(s) 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 hospitalisation, or an emergency room visit, or visit to/by a health care provider). The 
participants/participant’s parent(s)/LAR(s) will be instructed to contact the site as soon as 
possible to report medically attended event(s), as well as any events that, though not 
medically attended, are of participant/parental/LAR’s concern. Detailed information 
about reported unsolicited AEs will be collected by qualified site personnel and 
documented in the participant’s records. 
Unsolicited AEs that are not medically attended or perceived as a concern by the 
participant/participant’s parent(s)/LAR(s) will be collected during an interview with the 
participants/participant’s parent(s)/LAR(s) and by review of available medical records at 
the next visit. 
10.3.5. 
Adverse events of special interest (AESIs) 
Not applicable  
10.3.6. 
Clinical laboratory parameters and other abnormal assessments 
qualifying as AEs or SAEs  
If the investigator considers it necessary to conduct laboratory tests to rule out any 
SAE/Medically attended SAE during the participation in the study, those results should 
be shared with the central team. 
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 Sections 10.3.1 and 
10.3.2).  
The investigator must exercise his or her medical and scientific judgement in deciding 
whether an abnormal laboratory finding, or other abnormal assessment is clinically 
significant. 
10.3.7. 
Events or outcomes not qualifying as AEs or SAEs  
10.3.7.1. 
Pregnancy 
Female participants who become pregnant after administration of the study intervention 
may continue the study at the discretion of the investigator.  
While pregnancy itself is not considered an AE or SAE, any abnormal pregnancy 
outcome or complication or elective termination of a pregnancy for medical reasons will 
be recorded and reported as an SAE. Please refer to Section 10.3.2 for definition of SAE.  

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10.3.8. 
Recording and follow-up of AEs, SAEs, and pregnancies 
The participants/participants’ parent(s)/LAR(s) 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. 
An electronic Diary (eDiary) will be used in this study to capture solicited administration 
site or systemic events. The participant should be trained on how and when to complete 
the eDiary. 
Anyone who measures administration site or systemic events and who will record the 
event in the eDiary should be trained on using the eDiary. This training must be 
documented in the participant’s source record. 
Note: eDiary may be completed by a minor participant under the supervision of the 
participant’s parent(s)/LAR(s) provided the minor is capable of assessing and reporting 
the information to be recorded on eDiary. The ultimate accountability for completion of 
the eDiary remains with the participant’s parent(s)/LAR(s). The investigator should 
discuss this accountability with the participant’s parent(s)/LAR(s). Please see SPM for 
more detail 
Collect and verify completed eDiary during discussions with the participant/participant’s 
parent(s)/LAR(s) on Visit 2 (Day 31) and Visit 3 (Day 61). 
Any unreturned eDiary device will be sought from the participant/participant’s 
parent(s)/LAR(s) through telephone call(s) or any other convenient procedure.  
Refer to the SPM for more information regarding the use of eDiary.  

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10.3.8.1. 
Time period for collecting and recording AEs, SAEs, and pregnancies 
All solicited events that occur for 7 days following administration of each dose (RSV 
maternal vaccine or dTpa) of study intervention (Day 1 to Day 7) and (Day 31 to Day 38) 
must be recorded into the eDiary, irrespective of intensity. All other AEs occurring 
within this time frame should be recorded into the appropriate section of the eCRF, 
irrespective of their intensity or whether or not they are considered related to the study 
intervention. 
10.3.8.2. 
Follow-up of AEs, SAEs, pregnancies or any other events of interest 
After the initial AE/SAE/pregnancy or any other event of interest, the investigator is 
required to proactively follow each participant at subsequent visits/contacts. All SAEs 
will be followed until the event is resolved, stabilised, otherwise explained, or the 
participant is lost to follow-up. 
Other non-serious AEs must be followed until the end of the study or until the participant 
is lost to follow-up. 
10.3.8.2.1. Follow-up during the study 
If a participant dies during their participation in the study or during a recognised follow-
up period, GSK will be provided with any available post-mortem findings, including 
histopathology. 
10.3.8.2.2. 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 using a paper/electronic Expedited Adverse Events Report 
and/or pregnancy 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 as fully as possible. 
10.3.8.2.3. Follow-up of pregnancies 
Pregnant participants will be followed to determine the outcome of the pregnancy. At the 
end of the pregnancy, whether full-term or premature, information on the status of the 
mother and child will be forwarded to GSK using the electronic pregnancy report and the 
Expedited Adverse Events Report if applicable. Generally, the follow-up period does not 
need to be longer than 6 to 8 weeks after the estimated date of delivery. 
Regardless of the reporting period for SAEs in this study, if the pregnancy outcome is an 
SAE, it should always be reported as such. 
Furthermore, if the investigator becomes aware of any SAE occurring as a result of a 
post-study pregnancy AND it is considered by the investigator to be reasonably related to 
the study intervention, he/she must report this information to GSK as described in the 
Section 10.3.10. 

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10.3.8.3. 
Updating of SAE and pregnancy information after removal of write 
access to the participant’s eCRF 
When additional SAE or pregnancy information is received after write access to the 
participant’s eCRF is removed, new or updated information should be recorded on the 
appropriate paper report, with all changes signed and dated by the investigator. The 
updated report should be 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 11). 
10.3.9. 
Assessment of intensity and toxicity 
10.3.9.1. 
Assessment of intensity 
The intensity of the following solicited AEs will be assessed as described: 
Table 16 
Intensity scales for solicited events in adults and children of 6 years 
of age or more  
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 judgement. 
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 intensity should be assigned to 1 of the following categories: 
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. 
10.3.9.2. 
Assessment of causality 
The investigator must assess the relationship between study intervention and the 
occurrence of each unsolicited AE/SAE using clinical judgement. 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 and/or SmPC and/or Prescribing Information for marketed products to assist in 
making his/her assessment. 
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. 
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

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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. 
10.3.9.3. 
Medically attended visits 
For each solicited and unsolicited AE the participant experiences, the 
participant/participant’s parent(s)/LAR(s) will be asked if she received medical attention 
(defined as hospitalisation, or an otherwise unscheduled visit to or from medical 
personnel for any reason, including emergency room visits). Only serious medical 
attended visits will be recorded in the eCRF/ Expedited Adverse Events Report, and/if 
solicited in the eDiary.  
10.3.9.4. 
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). 

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10.3.10. 
Reporting of SAEs, pregnancies and other events 
10.3.10.1. 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 11 for the details on timeframes for reporting of SAEs/pregnancies.  
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 10.3.10.2 for information on back up systems in case the electronic 
reporting system does not work. 
10.3.10.2. 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. 
10.4. 
Appendix 4: Contraceptive guidance and collection of 
pregnancy information 
10.4.1. 
Definitions 
10.4.1.1. 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below). 

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10.4.1.1.1. Women not considered as women of childbearing potential 
• 
Premenarchal 
Menarche is the first onset of menses in a young female. Menarche is normally 
preceded by several changes associated with puberty including breast development 
and pubic hair growth.  
Additional evaluation should be considered if a participant’s fertility status is unclear 
(e.g., amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study intervention. 
• 
Premenopausal female with ONE of the following: 
− 
Documented hysterectomy 
− 
Documented bilateral salpingectomy 
− 
Documented bilateral oophorectomy 
Note: Documentation can come from the site personnel’s: review of participant’s medical 
records, medical examination, or medical history interview. 
• 
Postmenopausal female 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle stimulating hormone (FSH) level in the 
postmenopausal range may be used to confirm a postmenopausal state in women not 
using hormonal contraception or hormonal replacement therapy (HRT). However, in 
the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 
• 
Females on HRT and whose menopausal status is in doubt will be required to use a 
non-hormonal, highly effective contraception method if they wish to continue their 
HRT during the study. Otherwise, they must discontinue HRT to allow confirmation 
of postmenopausal status before study enrolment. 
10.4.2. 
Contraception guidance 
• 
Female participants of childbearing potential are eligible to participate if they agree 
to use a highly effective contraceptive method consistently and correctly according 
to the methods listed in GSK’s list of highly effective contraceptive methods (Table 
17).  

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Table 17 
Highly effective contraceptive methods 
Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of <1% per year when used consistently and correctly.  
Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation 
• 
Oral 
• 
Intravaginal  
• 
Transdermal  
Progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Injectable 
• 
Oral  
Highly Effective Methods That Are User Independent  
• 
Implantable progestogen-only hormonal contraception associated with inhibition of ovulation 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) 
• 
Bilateral tubal occlusion 
Vasectomised partner  
(A vasectomised partner is a highly effective contraception method provided that the partner is the sole male 
sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly 
effective method of contraception should be used.)  
Male partner sterilisation prior to the female participant’s entry into the study, and this male is the sole partner for that 
participant, 
(The information on the male sterility can come from the site personnel’s review of the participant’s medical 
records; medical examination and/or semen analysis, or medical history interview provided by her or her 
partner). 
Sexual abstinence  
(Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence 
needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.)  
10.4.3. 
Collection of pregnancy information 
10.4.3.1. 
Female participants who become pregnant 
Refer to Sections 8.3.1, 8.3.2, 10.3.8.1, 10.3.8.2 and 10.3.8.3 for further information on 
detection, recording, reporting and follow-up of pregnancies. 
Any female participant who becomes pregnant during the study will be followed to 
determine the outcome of the pregnancy. 
10.5. 
Appendix 5: Genetics 
Not applicable. 

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10.6. 
Appendix 6: Definition of medical device AE, adverse device 
effect (ADE), serious adverse device effect (SADE) and 
unanticipated SADE (USADE) 
10.6.1. 
Definition of medical device AE and adverse device effect (ADE) 
• 
Medical device AE is any untoward medical occurrence, in a clinical study 
participant, users, or other persons, temporally associated with the use of study 
intervention whether considered related to a medical device or not. 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 medical device. This definition includes events related to the medical device 
or comparator and events related to the procedures involved. 
• 
An adverse device effect (ADE) is an AE related to the use of a medical device. This 
definition includes any AE resulting from: 
− 
insufficient or inadequate instructions for use (i.e. user error), or 
− 
any malfunction of a medical device, or 
− 
intentional misuse of the medical device. 

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10.6.2. 
Definition of medical device SAE, SADE and USADE 
A medical device SAE is any serious adverse event that: 
a. 
Led to death  
b. Led to serious deterioration in the health of the participant, that either resulted in: 
− 
A life-threatening illness or injury. The term ‘life-threatening' in the definition 
of ‘serious' refers to an event in which the participant was at risk of death at 
the time of the event. It does not refer to an event, which hypothetically might 
have caused death, if it were more severe. 
− 
A permanent impairment of a body structure or a body function. 
− 
Inpatient or prolonged hospitalization. Planned hospitalization for a pre-
existing condition, or a procedure required by the protocol, without serious 
deterioration in health, is not considered an SAE. 
− 
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c. 
Led to fetal distress, fetal death or a congenital abnormality or birth defect 
Serious Adverse Device Effect (SADE) definition 
• 
A SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
• 
Any device deficiency that might have led to an SAE if appropriate action had not 
been taken or circumstances had been less fortunate. 
Unanticipated SADE (USADE) definition 
• 
An USADE (also identified as UADE in US Regulations 21 CFR 813.3), is a 
serious adverse device effect that by its nature, incidence, severity or outcome has 
not been identified in the current version of the IB. 
10.6.3. 
Recording and reporting of medical device AE, ADEs, SADEs and 
USADE 
• 
Any device deficiency must be reported to GSK within 24 hours after the 
investigator determines that the event meets the definition of a device deficiency. 
• 
Refer to paper ‘Medical device or combination product with device 
deficiency/incident report form’ for details on transmission of this information to the 
sponsor. 
• 
GSK will review all device deficiencies, determine and document in writing whether 
they could have led to an SAE. These device deficiencies will be reported to the 
regulatory authorities and IRBs/IECs as required by national regulations. 
• 
If required or in case of any issues refer to the general safety contacts for SAE/AE 
reporting in Section 8.3.3.1 

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10.7. 
Appendix 7: Country-specific requirements 
Germany  
A booster for Tdap-IPV (e.g. Boostrix-Polio) is recommended in the age group 9-17 
YOA. However, IPV mono vaccines are licensed and can be administered separately. For 
MAT-039 study, Boostrix and IPV will be given separately in the group 9-17 YOA [IPV 
is allowed any time except the period starting 30 days before the first dose and ending 30 
days after the last dose of study intervention(s) administration]. 

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10.8. 
Appendix 8: Abbreviations and glossary of terms 
10.8.1. 
List of abbreviations  
ADE 
Adverse Device Effect 
AE: 
Adverse Event 
CLS: 
Clinical Laboratory Sciences 
COVID-19 
Corona Virus Disease 2019 
CSR 
Clinical Study Report 
DRE 
Disease-related event 
eCRF: 
electronic Case Report Form 
EoS: 
End of Study 
GCP: 
Good Clinical Practice 
GSK: 
GlaxoSmithKline 
IB: 
Investigator Brochure 
ICF: 
Informed Consent Form 
ICH: 
International Council on Harmonisation 
LML 
Local Medical Lead 
LSLV: 
Last Subject Last Visit 
MedDRA: 
Medical Dictionary for Regulatory Activities 
QTL 
Quality Tolerance Limit 
RRA: 
Recruitment/Randomization Agreement 
SAE: 
Serious Adverse Event 
SBIR: 
Source data Base for Internet Randomization  
SmPC: 
Summary of Product Characteristics 
SPM: 
Study Procedures Manual 
WOCBP 
Woman of Childbearing Potential 
 

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10.8.2. 
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 adverse event (AE) can therefore be any 
unfavourable 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 adverse 
event  
In an open-label study, no blind is used. Both the 
investigator and the participant know the identity of the 
intervention assigned.  
Caregiver: 
A ‘caregiver’ is someone who  
− 
lives in the close surroundings of a participant 
and has a continuous caring role or 
− 
has substantial periods of contact with a 
participant and is engaged in his/her daily 
health care (e.g. a relative of the participant, a 
nurse who helps with daily activities in case of 
residence in a nursing home).  
In the context of a clinical study, a caregiver could 
include an individual appointed to oversee and support 
the participant's compliance with protocol specified 
procedures. 
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. 

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Child in care: 
A child who has been placed under the control or 
protection of an agency, organisation, institution or 
entity by the courts, the government or a government 
body, acting in accordance with powers conferred on 
them by law or regulation. The definition of a child in 
care can include a child cared for by foster parents or 
living in a care home or institution, provided that the 
arrangement falls within the definition above. The 
definition of a child in care does not include a child who 
is adopted or has an appointed legal guardian. 
Combination product: 
Combination product comprises any combination of  
− 
drug  
− 
device  
− 
biological product  
Each drug, device and biological product included in a 
combination product is a constituent part.  
Eligible: 
Qualified for enrolment into the study based upon strict 
adherence to inclusion/exclusion criteria. 
Enrolment: 
The process of registering a participant into a clinical 
study by assigning participant identification number 
after signing the ICF. 
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 studies. 
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. 
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 authorisation when used in a way different 
from the approved form, or when used for an 

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unapproved indication, or when used to gain further 
information about an approved use.  
Synonym: Investigational Medicinal Product 
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 
Legally acceptable 
representative: 
An individual, judicial or other body authorised under 
applicable law to consent on behalf of a prospective 
participant to the participant's participation in the 
clinical study. 
The terms legal representative or legally authorised 
representative are used in some settings. 
Medical device deficiency: 
A device deficiency is an inadequacy of a medical 
device with respect to its identity, quality, durability, 
reliability, safety, or performance. Device deficiencies 
include malfunctions, use errors and information 
supplied by the manufacturer. 
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. 
Pharmacogenomics 
The International Council on Harmonisation (ICH) E15 
Guidance for Industry defines pharmacogenomics as the, 
“Study of variation of DNA and RNA characteristics as 
related to drug or treatment response.”  
Pharmacogenetics, a subset of pharmacogenomics, is 
“the study of variations in DNA sequence as related to 
drug response.” Pharmacogenomic biomarkers include 

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germline (host) DNA and RNA as well as somatic 
changes (e.g. mutations) that occur in cells or tissues.  
Pharmacogenomic biomarkers are not limited to human 
samples but include samples from viruses and infectious 
agents as well as animal samples. The term 
pharmacogenomic experiment includes both the 
generation of new genetic or genomic (DNA and/or 
RNA) data with subsequent analysis as well as the 
analysis of existing genetic or genomic data to 
understand drug or treatment response 
(pharmacokinetics, safety, efficacy or effectiveness, 
mode of action).  
Proteomic and metabolomic biomarker research is not 
pharmacogenomics. 
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.  
Randomisation: 
Process of random attribution of intervention to 
participants to reduce selection bias. 
Remote visit: 
This term refers to the visit conducted in the place other 
than the study site. 
Self-contained study: 
Study with objectives not linked to the data of another 
study. 
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. 

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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. 
Study monitor: 
An individual assigned by the sponsor and responsible 
for assuring proper conduct of clinical studies at 1 or 
more investigational sites. 
Telemedicine: 
Telemedicine refers to the use of information 
technologies and electronic communications to provide 
clinical services to patients virtually. The digital 
transmission of medical imaging, virtual medical 
diagnosis and evaluations, and video consultations with 
specialists are all examples of telemedicine. 
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. 
Virtual visit: 
This term refers to study visits conducted using 
multimedia or technological platforms. 

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10.9. 
Appendix 9: Protocol Amendment history 
The Protocol Amendment Summary of Changes Table for the current amendment 
is located directly before the Table of Contents (TOC). 
DOCUMENT HISTORY 
Document 
Date of Issue 
Protocol 
11 August 2021 
Protocol Amendment 1 
17 March 2021 
Detailed description of the current Protocol amendment: 
Section 1.2 
Schema 
Based on all safety information available from RSV MAT-009 study (following 
administration of RSV MAT vaccine), there will be no further enrollment and 
vaccination of participants in this study.  
There will be no more blood samples collected as part of this study, except the study 
participants who has received RSV maternal vaccine at Visit 1. A blood sample will be 
collected and a urine pregnancy test will continue to be performed for them at Visit 2. 
Participants who are enrolled and are due to receive dTpa during their Visit 2 will no 
longer receive the dTpa as part of this study. However, as per the local standard of care 
and or immunization recommendation and after consultation with their attending 
physician; the participant can always receive any commercially available dTpa vaccine. 
GSK will bear the cost of the vaccine. 
All participants who receive the first dose of study interventions (RSV maternal vaccine 
or dTpa) will be followed for safety and reactogenicity and evaluated for both solicited 
administration site (local) and systemic events within 7 days of vaccination, unsolicited 
AEs within 30 days of vaccination, SAEs and pregnancy outcomes throughout the study 
period (180 days after first dose of study interventions). 
All safety data will be reviewed by a Safety Review Team (SRT) and an independent 
data monitoring committee (IDMC). (See Section 8.2.3 for more details) 
Section 1.3 
Schedule of activities 
Contact 3 and Visit 3 removed. Visit 4 updated to telephone contacts. 

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Table 2 
Intervals between study visits 
Interval 
Optimal timing  
Allowed interval (Study day) 
Visit 1*→ Contact 1 
8 days  
7 - 9 days  
Visit 1→ Visit 2 
31 days 
31 - 45 days  
Visit 2→ Contact 2 
8 days  
7 - 9 days  
Visit 2→ Visit 3/Contact 3 
31 days 
31 - 45 days  
Visit 1 → Visit 4a** Contact 2 
180 days 
165 - 195 days  
Visit 2→ Visit 4b*** 
180 days 
165 - 195 days  
*The interval between study visits begins at the time of vaccination during Visit 1 timepoint. 
** RSV_dTpa-P, RSV_dTpa-A groups only 
*** dTpa_RSV-P, dTpa_RSV-A groups only 
Section 2.1 
Study Rationale 
• 
Following review of data collected so far from the RSV MAT-009 study in 
pregnant women, safety signals have been identified. An imbalance in the 
proportion of preterm births and neonatal deaths have been observed in infants 
born to vaccinated mothers who received RSV maternal vaccine versus those who 
received a placebo. The safety signals are being investigated and, although at this 
time a cause has not been determined, based on the above observations, GSK has 
nevertheless decided to stop enrolment and vaccination for all actively enrolling 
RSV MAT studies. 
• 
There will be no new participants included in this study. However, safety 
monitoring of all 8 study participants (of the planned 252 study participants) 
enrolled and vaccinated in RSV MAT-039 study in a study site in the US will 
continue during the rest of the study period. 
• 
The vaccination planned at visit 2 is removed. Therefore, Contact 2 at Day 38 and 
Visit 3 at Day 61 are not applicable anymore. Visit 4a (Day 181) and Visit 4b (Day 
211) are replaced by a telephone contact at Day 181.  
• 
 A blood sample for immunogenicity assessment in the study participants who 
received first dose of RSV Maternal vaccine will continue to be collected at Visit 2 
only. No other blood samples will be collected. 
• 
All planned objectives will be analysed and reported in a descriptive manner for 
the 8 enrolled participants. 
Section 2.3 
Benefit/Risk assessment 
Following a recommendation from the IDMC, the Sponsor made the decision to pause 
the enrollment, randomization and vaccination of pregnant study participants in our 
active studies based on an observation of imbalance of the proportion of preterm births 
between the vaccine group and the placebo group in the RSV MAT-009 study in 
pregnant women. This pause was to allow for an evaluation of the available data in 
RSV MAT-009 to better understand the safety signal observed. Following a review of 
additional unblinded data from RSV MAT-009 trial in which a higher proportion of 
neonatal deaths reported in the treatment group compared to the placebo group was 
also observed, the Sponsor decided to STOP enrollment and vaccination in these 
studies.  

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The safety signals are being investigated and, although at this time a cause has not 
been determined, as a precautionary measure GSK stopped active enrollment and 
further vaccination of participants in the RSV MAT studies enrolling both pregnant 
women on February 25, 2022 and non-pregnant women on March 1, 2022. The study 
remains ongoing for safety follow-up. Participants already vaccinated will continue to 
be monitored until the end of the study. 
Table 3 
Study objectives, endpoints and estimands 
Objectives 
Endpoint(s) and estimand(s) 
Primary 
• 
To evaluate the safety following administration 
of RSV maternal vaccine in the pediatric (9-17 
YOA) and adult (18-49 YOA) study groups during 
the entire study period. (180 days post RSV 
maternal vaccination) 
The number and percentage of participants in each 
study group reporting  
• 
SAEs during the entire study period 
• 
AEs/SAEs/leading to study withdrawal during 
the entire study period  
• 
To evaluate the reactogenicity and safety following 
administration of RSV maternal vaccine and dTpa 
control vaccine in the pediatric and adult study 
groups up to 30 days (including day of study 
intervention administration). 
The number and percentage of participants in each study 
group reporting  
• 
Each solicited administration site event collected 
during the 7 days follow-up post Dose 1 (Day 1 to 
Day 7 post intervention including day of vaccination)  
• 
Each solicited systemic event during the 7 days 
follow-up period post Dose 1 
• 
Each unsolicited AE collected during the 30 days 
follow-up period post Dose 1 
• 
SAEs/MAEs during the 30 days follow-up period 
post Dose 1 
• 
AEs/SAEs/MAEs leading to study withdrawal for the 
30 days follow-up period post Dose 1  
Secondary 
• 
To evaluate the immunogenicity following the 
administration of RSV maternal vaccine in terms 
of RSV A neutralizing Ab titers in pediatric (9-17 
YOA) and in adult (18-49 YOA) groups.  
RSV A neutralizing antibody titers at pre-dosing and 
Day 31 post RSV maternal vaccine administration 
• 
To evaluate the immunogenicity (RSVPreF3 IgG, 
RSV A Neutralizing Ab and RSV B Neutralizing Ab) 
of RSV maternal vaccine in the pediatric (9-17 YOA) 
and 18-49 YOA (adult) groups. 
• 
RSV B Neutralizing Ab titers and RSVPreF3 IgG 
ELISA concentration at pre-dosing and Day 31, post 
RSV maternal vaccine administration. 

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Section 4.1 
Overall design 
Figure 2 
Study design overview 
 
* Screening and vaccination will happen on Visit 1 (Day 1).  
** (RSV_dTpa-P & RSV_dTpa-A) Blood sampling to be done at Visit 1 and Visit 2 for participants receiving RSV 
maternal vaccine at Visit 1.A urine pregnancy test will be done at Visit 2 if the participant has received RSV 
maternal vaccine in their first visit.  
• 
Study Type: Cross over design.  
• 
Study Duration: The study interventions were administered at Visit 1 and the 
participant will be followed for 6 months (180 days post RSV maternal vaccine 
administration) subsequent the RSV maternal vaccine until the study conclusion. 
• 
Blinding: This study will be an open label study. 
• 
Control Used: dTpa will be used as an active control for safety and reactogenicity 
evaluation and to maximize the benefit to participants*.  
* The participants in RSV_dTpa-P and RSV_dTpa-A group will be provided with 
an option to decide to receive dTpa vaccination as part of standard of care/local 
recommendation on immunization outside this study. 
• 
Sample Collection Time Points  
− 
RSV_dTpa-P: Day 1, Day 31, Day 181 
− 
RSV_dTpa-A: Day 1, Day 31, Day 181  
• 
Vaccination schedules are described in Table 2.  
• 
Randomized intervention allocation is described in in Table 4 and Section 6.3. 
• 
Study (intervention) groups are described in Table 4. 

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• 
Data collection: e-Diaries will be used to collect solicited event data. Unsolicited 
Adverse event data will be collected through questioning at study visits/contacts and 
reported into the eCRF, as appropriate. See Section 8.3.2 for more detail. 
• 
Safety monitoring will be conducted by SRT and IDMC. 
Table 4 
Study groups, intervention, and blinding 
Study groups** 
Number of 
participants# 
Age 
(Min-Max  
Study intervention(s)* 
Blinding 
Visit1→Visit 4a 
or Visit 4b 
RSV_dTpa-P 
63 
9-17 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
Open Label 
dTpa_RSV-P 
63 
9-17 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
RSV_dTpa-A 
63 
18-49 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
dTpa_RSV-A 
63 
18-49 YOA 
RSVPreF3 
Boostrix (dTpa_300 or dTpa_500) 
*RSVPreF3=RSV maternal Vaccine 
#Only 8 study participants have been enrolled in the study.  
**There will no further enrolment and vaccination in all the study groups. 
Table 5 
Study interventions administered 
 
RSV maternal Vaccine* 
Boostrix (dTpa_500) 
Boostrix (dTpa_300)# 
Study intervention 
name:  
RSVPreF3  
NaCl Solution 
dTpa 
dTpa 
Study intervention 
Formulation 
RSVPreF3 
(120 µg) 
Sodium 
Chloride (NaCl) 
(0.9%); Water 
for injections 
DT1 (≥ 2 IU); 
TT1 (≥ 20 IU); 
PT (8 µg)1; 
FHA (8 µg)1; 
PRN (2.5 µg)1; 
1adsorbed on Al(OH)3 (0.3 mg 
Al3+) and AlPO4 (0.2 mg Al3+); 
Water for injections q.s. 0.5 mL 
DT1 (≥ 2 IU); 
TT1 (≥ 20 IU); 
PT (8 µg)1; 
FHA (8 µg)1; 
PRN (2.5 µg)1; 
1adsorbed on Al(OH)3 
(0.3 mg Al3+); 
Water for injections 
q.s. 0.5 mL 
Presentation 
Powder for solution for 
injection (vial) 
Suspension for injection 
(syringe) 
Suspension for 
injection (syringe) 
Solution for solution for 
injection (syringe) 
Type 
Study 
Control 
Control 
Product Category 
Combination Product  
Combination Product  
Combination Product 
Route of 
administration: 
IM 
IM 
IM 
Location 
Arm 
Arm 
Arm 
Laterality ** 
non-dominant  
non-dominant  
non-dominant  
No of doses 
1 
1 
1 
Volume to be 
administered: 
whole content*** 
whole content**** 
whole content**** 
Side/site route 
IM/non-dominant arm 
IM/non-dominant arm 
IM/non-dominant arm 
Packaging, 
labelling 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 
GSK 
GSK  
* RSV maternal Vaccine=RSVPreF3  

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** The non-dominant arm is the preferred arm of injection. In case it is not possible to administer the vaccine / product 
in the non-dominant arm, an injection in the dominant arm may be performed. 
*** The entire content of the pre-filled NaCl syringe will be transferred into the vial for reconstitution. The entire contents 
of the reconstituted vaccine/product will be withdrawn for administration. Refer to the SPM for more details. 
**** The entire content of the of the syringe will be administered. Refer to the SPM for more detail. 
#This dose form of Boostrix is not applicable in the study anymore as no non-US sites were initiated before 
the decision to stop the study. 
Section 8.1.1 Biological samples 
Table 6 
Biological samples 
Sample type 
Collected to 
Evaluate* 
Time point  
(RSV_dTpa-P, 
RSV_dTpa-A) 
Minimum 
Quantity per 
participant 
Unit 
Additional Information 
Whole blood for 
immune response 
Visit 1 (Day 1) 
~5 
mL 
Immune response: 5 mL (~ 2 mL 
serum). 
Whole blood for 
immune response 
Visit 2 (Day 31) 
~5 
mL 
Immune response: 5 mL (~ 2 mL 
serum).  
 
 
~10 
mL 
Urine for 
Pregnancy** 
Visit 1 (Day 1) and 
Visit 2 (Day 31) 
 
*The blood sample to be taken for immune response must be taken before administering the study intervention. 
**Urine sample was collected for all subjects at Visit 1. At Visit 2, urine sample will only be collected for study 
participants enrolled in RSV dTpa-P and RSV dTpa-A groups. 
Section 8.1.2 Laboratory Assays 
Table 7 
Laboratory assays 
*NEU=Neutralization Assay; ELI=ELISA or enzyme-linked immunosorbent assay 
** for participants receiving RSV maternal vaccine at Visit 1 
*** Visit 2(Day 31 prior to immunization) is no more applicable after the study stop 
Section 8.1.3 Immunological readouts 
The following readouts are applicable to only 8 participants enrolled in the study. 
Sampling time 
points 
System 
Component 
Method* 
Groups 
Laboratory 
Visit 1** 
(Day 1  
prior to 
immunization) 
Serum 
Respiratory Syncytial Virus 
A Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
B Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A 
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
PreF3 Ab.IgG 
concentration 
ELI 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Visit 2*** 
(Day 31 
prior to 
immunization) 
Serum 
Respiratory Syncytial Virus 
A Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
B Ab neutralizing 
NEU 
RSV_dTpa-P 
RSV_dTpa-A 
GSK or GSK 
designated lab 
Serum 
Respiratory Syncytial Virus 
PreF3 Ab.IgG 
concentration 
ELI 
RSV_dTpa-P 
RSV_dTpa-A  
GSK or GSK 
designated lab 

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Table 8 
Immunological read-outs  
Blood sampling timepoint 
Approximate No. 
participants 
Component 
Type of 
contact and 
timepoint 
Sampling 
timepoint 
Visit 1* (Day 1) 
pre- 1st 
vaccination 
126 
Respiratory Syncytial Virus A Ab neutralizing 
126 
Respiratory Syncytial Virus B Ab neutralizing 
126 
Respiratory Syncytial Virus PreF3 Ab.IgG concentration 
Visit 2 (Day 31) post 1st 
vaccination 
252 
Respiratory Syncytial Virus A Ab neutralizing 
252 
Respiratory Syncytial Virus B Ab neutralizing 
252 
Respiratory Syncytial Virus PreF3 Ab.IgG concentration 
* for participants receiving RSV maternal vaccine at Visit 1 
Section 8.3.1 Time period and frequency for collecting AE, SAE and other safety 
information 
Event 
V1 
 
C1 
 
V2 
Contact 2  
D1 D7 D8 D30 D31 
180 days post RSV 
vaccination*** 
Solicited administration site event and systemic 
AEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unsolicited AEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AEs leading to withdrawal from the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAEs* 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MAEs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancies 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. V=Visit; D=Day; C=Contact 
* SAEs related to study participation or concurrent GSK medication/vaccine will be monitored from the time of 
screening to the time of the immunization. Both will be conducted on the same visit. 
*** For all study groups at Day 181 
Section 9 
Statistical considerations 
This section will not be applicable as the study has been stopped. However only 
descriptive statistics will be provided for immunogenicity, safety and reactogenicity at 
an individual level. 
Section 9.1 
Statistical hypotheses 
No hypothesis test will be performed. All analyses will be descriptive. 

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Section 9.3.1.1 
Safety 
 
Primary Safety Endpoints  
Statistical Analysis Methods 
Pediatric and 
Adult 
participants 
The number of participants in each 
study group reporting Each solicited 
administration site event collected 
during the 7 days follow-up period 
post Dose 1 (Day 1 to Day 7 post 
intervention including day of 
vaccination) 
• 
Each solicited systemic 
event collected during the 
7 days follow-up period 
post Dose 1 
• 
Each unsolicited AE 
collected during the 30 
days follow-up period 
post Dose 1 
• 
SAEs/MAES collected 
during the 30 days follow-
up period post Dose 1 
• 
AEs/SAEs leading to 
study withdrawal for the 
30 days follow-up period 
post Dose 1  
The number of adult and pediatric participants reporting 
each solicited administration site event (any grade, each 
grade) and solicited systemic event (any, each grade) 
during the 7-day (Day 1 to Day 7 post intervention including 
day of vaccination) follow-up period after dosing will be 
tabulated by maximum intensity per participant for each 
study group.  
The number of participants reporting: 
• 
at least one administration site AE (solicited) 
• 
at least one systemic AE (solicited) 
during the 7-day follow-up period after dosing will be 
tabulated .  
The number and percentage of participants reporting: 
• 
at least one AE (unsolicited)  
• 
at least one SAE/MAE 
• 
at least one AE/SAE leading to study withdrawal 
during the 30-days post Dose 1 follow-up period after 
dosing will be tabulated .  
The same computations will be done for Grade 3 solicited 
and unsolicited AEs, for any AEs considered related to 
vaccination, for any Grade 3 AEs considered related to 
vaccination and for any AEs resulting in a medically 
attended visit (i.e., MAEs). 
The number of participants in 
each study group reporting  
• 
SAEs during the entire 
study period. 
AEs/SAEs leading to study 
withdrawal during the entire 
study period. 
The number of both the pediatric and adult participants 
reporting: 
• 
at least one SAE 
• 
at least one (S)AE leading to study withdrawal 
during the entire study period will be tabulated 
by group/doses and by MedDRA preferred term. 
By participant listings of SAEs, (S)AEs leading to study 
withdrawal and MAEs will be prepared, but will not be 
released until the final, unblinded, analysis has been 
completed. 
Section 9.3.2.1 
Immunogenicity 
 
Secondary Immunogenicity 
Endpoints 
Statistical Analysis Methods 
Pediatric 
and Adult 
participants 
RSV A neutralizing antibody titers 
at pre-dosing and Day 31 post 
RSV maternal vaccine 
administration 
For RSV A neutralizing antibody titers at pre- dosing 
and Day 31 post RSV maternal vaccine administration :  
• 
Antibody titers/concentrations will be displayed 
using reverse cumulative curves. 
• 
Individual antibody titers at pre-dosing and Day 
31 will be listed. 
• 
Individual post-dosing versus pre-dosing results 
will be plotted using scatter plots. 
• 
Individual fold increase of antibody titers at Day 
31 post RSV maternal vaccine administration over 
pre-dosing will be tabulated . 
▪ 
RSV B Neutralizing Ab titers 
and RSVPreF3 IgG ELISA 
For each assay, at each timepoint:  

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Secondary Immunogenicity 
Endpoints 
Statistical Analysis Methods 
concentration at pre-dose, Day 
31 post RSV maternal vaccine 
administration. 
Antibody concentrations/titers will be displayed using 
reverse cumulative curves. 
• 
Individual antibody titers/concentrations at pre-dosing 
and Day 31 will be listed 
• 
Individual post-dosing versus pre-dosing results will 
be plotted using scatter plots.  
• 
Individual fold increase of antibody 
titers/concentrations at each post-dosing timepoint 
over pre-dosing will be tabulated. 
Relationship between RSVPreF3 IgG-specific antibody 
concentration, RSV A neutralizing antibody, and RSV B 
neutralizing antibody at baseline and each post RSV 
maternal vaccine administration timepoint will be explored 
using scatter plots of individual values. 
 

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11. 
REFERENCES 
CHMP, Guideline on the clinical evaluation of medicinal products indicated for the 
prophylaxis or treatment of respiratory syncytial virus (RSV) disease 
(EMA/CHMP/257022/2017). (Adopted 18 October 2018). 
Christy C, Pichichero ME, Reed GF, Effect of Gender, Race, and Parental Education on 
Immunogenicity and Reported Reactogenicity of Acellular and Whole-Cell Pertussis Vaccines. 
Pediatrics (1995), 96(3) 
Haralambieva IH, Ovsyannikova IG, Pankratz VS, Kennedy RB, Jacobson RM, Poland 
GA. The genetic basis for interindividual immune response variation to measles vaccine: 
new understanding and new vaccine approaches. Expert Rev Vaccines. 2013; 12(1):57–
70. 
Hasin DS, O’Brien CP, Auriacombe M, et al. DSM-5 Criteria for Substance Use 
Disorders: Recommendations and Rationale. The American journal of psychiatry. 
2013;170(8):834-851. Doi:10.1176/appi.ajp.2013.12060782. 
ICH E11(R1), Addendum to ICH E11: Clinical investigation of medicinal products in the 
pediatric population. ICH, 2017. GUIDELINE FOR GOOD CLINICAL PRACTICE 
(ich.org) 
Kollmann TR. Variation between Populations in the Innate Immune Response to Vaccine 
Adjuvants. Front Immunol. 2013; 4:81 
Pérez-Losada M, Posada D, Arenas M, et al. Ethnic differences in the adaptation rate of 
HIV gp120 from a vaccine trial. Retrovirology. 2009; 6:67. 
Theeten H, Van Damme P, Hoppenbrouwers K, Vandermeulen C, Leback E, Sokal EM, 
Wolter J, Schuerman L. Effects of lowering the aluminium content of a dTpa vaccine on 
its immunogenicity and reactogenicity when given as a booster to adolescents. Vaccine. 
2005 Feb 10;23(12):1515-21. doi: 10.1016/j.vaccine.2004.08.002. PMID: 15670888. 
WHO. Global health estimates 2015: deaths by cause, age, sex, by country and by region, 
2000–2015. Geneva: WHO; 2016. 
World Health Organization [WHO]. Global Surveillance for COVID-19 caused by 
human infection with COVID-19 virus: Interim Guidance. March 2020. Available at: 
https://www.who.int/docs/default-source/coronaviruse/2020-03-20-
surveillance.pdf?sfvrsn=e6be6ef1_2Accessed 8 May 2020. 

Signature Page for  217354 TMF-14524218 v1.0
Signature Page for TMF-14524218 v1.0
Reason for signing: Approved
Name:
Role: Approver
Date of signature: 18-Mar-2022 11:32:58 GMT+0000
PPD