Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV
NCT ID: NCT03636906
Last Updated: 2022-07-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
201 participants
INTERVENTIONAL
2019-04-08
2021-07-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
NCT03606512
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
NCT00806195
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT03691610
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
NCT06143046
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RSV1D Pooled Group
Subjects 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.
RSV (GSK3389245A) lower dose formulation vaccine
1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.
GSK's multicomponent meningococcal B vaccine
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.
Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
GSK's pneumococcal polysaccharide conjugate vaccine
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.
GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
Placebo
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.
RSV2D Pooled Group
Subjects 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.
RSV (GSK3389245A) higher dose formulation vaccine
2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.
GSK's multicomponent meningococcal B vaccine
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.
Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
GSK's pneumococcal polysaccharide conjugate vaccine
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.
GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
Comparator_Placebo Pooled Group
Subjects 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).
GSK's multicomponent meningococcal B vaccine
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.
Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
GSK's pneumococcal polysaccharide conjugate vaccine
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.
GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RSV (GSK3389245A) lower dose formulation vaccine
1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.
RSV (GSK3389245A) higher dose formulation vaccine
2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.
GSK's multicomponent meningococcal B vaccine
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.
Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
GSK's pneumococcal polysaccharide conjugate vaccine
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.
GSK's meningococcal group A, C, W-135 and Y conjugate vaccine
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.
Placebo
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Previous, current or planned administration of Synagis (palivizumab).
* Neurological complications following any prior vaccination.
* Born to a mother known or suspected to be Human Immunodeficiency Virus (HIV)-positive .
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
* Family history of congenital or hereditary immunodeficiency.
* Previous vaccination with a recombinant simian or human adenoviral vaccine.
* History of any reaction or hypersensitivity to any component of the vaccines (investigational or control) or placebo used in this study or any contraindication to them.
* Hypersensitivity to latex.
* Current severe eczema.
* Acute disease and/or fever at the time of enrolment (Visit 1).
* Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
* Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
* Any other conditions that the investigator judges may interfere with study procedures, findings.
* Any conditions that could constitute a risk for the subjects while participating to this study.
* Weight below the fifth percentile of the local weight-for-age curve according to the World Health Organization (WHO) weight- for- age tables. Participating in another clinical study, at any time during the study period, in which the subject or mother (if breastfeeding) has been or will be exposed to an investigational or a non-investigational vaccine/product.
* Planned move to a location that will prohibit participating in the trial until study end.
* For Thailand only, subjects who have received Synflorix prior to enrolment.
6 Months
7 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil
GSK Investigational Site
Ribeirão Preto, São Paulo, Brazil
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Cali, , Colombia
GSK Investigational Site
Järvenpää, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
México, , Mexico
GSK Investigational Site
Chiriquí, , Panama
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Dębica, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Trzebnica, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Burgos, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Majadahonda (Madrid), , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Eskişehir, , Turkey (Türkiye)
GSK Investigational Site
Izmir, , Turkey (Türkiye)
GSK Investigational Site
Kayseri, , Turkey (Türkiye)
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-000431-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
204894
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.