Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Infants
2 other identifiers
interventional
201
13 countries
37
Brief Summary
The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Typical duration for phase_1
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedStudy Start
First participant enrolled
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2021
CompletedResults Posted
Study results publicly available
July 27, 2022
CompletedJuly 27, 2022
July 1, 2022
9 months
August 16, 2018
May 13, 2022
July 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1)
Assessed solicited local AEs are erythema, pain and swelling at injection site. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter greater than 0 millimeters. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.
During a 7-day follow-up period after the first vaccination (administered at Day 1)
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31)
Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.
During a 7-day follow-up period after the second vaccination (administered at Day 31)
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1)
Assessed solicited general adverse events are drowsiness, fever \[defined as temperature equal to or above (\>=) 38.degrees Celsius (C)/100.4 Fahrenheit (F) by any route\], irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.
During a 7-day follow-up period after the first vaccination (administered at Day 1)
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31)
Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.
During a 7-day follow-up period after the second vaccination (administered at Day 31)
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs are reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.
During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Assessed serious adverse events (SAEs) include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of theindividual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.
From Day 1 up to Day 61
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Special Interest)
Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of special interest. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.
During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31
Secondary Outcomes (8)
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions)
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions)
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
Number of Subjects With SAEs From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the First RSV Transmission Season (up to 1 Year)
From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)
From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
- +3 more secondary outcomes
Study Arms (3)
RSV1D Pooled Group
EXPERIMENTALSubjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
RSV2D Pooled Group
EXPERIMENTALSubjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.
Comparator_Placebo Pooled Group
ACTIVE COMPARATORSubjects received either one of interventions schedules as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . * 2 doses of Placebo alone (administered at Days 1 and 31).
Interventions
1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.
2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.
3 doses of GSK's multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.
3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.
3 doses of GSK's pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.
2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.
1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.
Eligibility Criteria
You may qualify if:
- Subjects' parent(s)/Legally Acceptable Representative \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between and including 6 and 7 months of age (from the day the infant becomes 6 months of age until the day before the infant achieves 8 months of age) at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born full-term with a minimum birth weight of 2.5 kilograms (kg).
- Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.
You may not qualify if:
- Child in care
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥ 0.5 milligrams (mg)/kg/day (for pediatric subjects), or equivalent. Topical steroids are allowed.
- Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
- Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines. Scheduled routine pediatric vaccines may be administered ≥ 7 days before a dose of study vaccine or ≥ 7 days following a dose of study vaccine, with the exception of live viral vaccines which may be administered ≥ 14 days before a dose or ≥ 7 days after a dose.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- A history of, or on-going confirmed RSV disease or highly compatible clinical picture.
- Serious chronic illness.
- Major congenital defects.
- History of any neurological disorders or seizures.
- History of or current autoimmune disease.
- History of recurrent wheezing in the subject's lifetime.
- History of chronic cough.
- Previous hospitalization for lower respiratory illnesses.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (37)
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
Louisville, Kentucky, 40243, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130-100, Brazil
GSK Investigational Site
Ribeirão Preto, São Paulo, 14048-900, Brazil
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Montreal, Quebec, H3T 1C5, Canada
GSK Investigational Site
Québec, G1V 4G2, Canada
GSK Investigational Site
Cali, 760042, Colombia
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Rome, Lazio, 00165, Italy
GSK Investigational Site
México, 04530, Mexico
GSK Investigational Site
Chiriquí, 0401, Panama
GSK Investigational Site
Panama City, 07126, Panama
GSK Investigational Site
Panama City, 0801, Panama
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Gdansk, 80-542, Poland
GSK Investigational Site
Trzebnica, 55-100, Poland
GSK Investigational Site
Warsaw, 02-739, Poland
GSK Investigational Site
Wroclaw, 50368, Poland
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda (Madrid), 28222, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41014, Spain
GSK Investigational Site
Valencia, 46020, Spain
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Eskişehir, 26040, Turkey (Türkiye)
GSK Investigational Site
Izmir, 35340, Turkey (Türkiye)
GSK Investigational Site
Kayseri, 38030, Turkey (Türkiye)
GSK Investigational Site
Manchester, M13 9WL, United Kingdom
GSK Investigational Site
Southampton, S016 6YD, United Kingdom
Related Publications (1)
Saez-Llorens X, Norero X, Mussi-Pinhata MM, Luciani K, de la Cueva IS, Diez-Domingo J, Lopez-Medina E, Epalza C, Brzostek J, Szymanski H, Boucher FD, Cetin BS, De Leon T, Dinleyici EC, Gabriel MAM, Ince T, Macias-Parra M, Langley JM, Martinon-Torres F, Ramet M, Kuchar E, Pinto J, Puthanakit T, Baquero-Artigao F, Gattinara GC, Arribas JMM, Ramos Amador JT, Szenborn L, Tapiero B, Anderson EJ, Campbell JD, Faust SN, Nikic V, Zhou Y, Pu W, Friel D, Dieussaert I, Lopez AG, McPhee R, Stoszek SK, Vanhoutte N. Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial. J Infect Dis. 2024 Jan 12;229(1):95-107. doi: 10.1093/infdis/jiad271.
PMID: 37477875DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Observer blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2018
First Posted
August 17, 2018
Study Start
April 8, 2019
Primary Completion
January 16, 2020
Study Completion
July 22, 2021
Last Updated
July 27, 2022
Results First Posted
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.