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 RSV-seropositive Infants
NCT ID: NCT02927873
Last Updated: 2021-10-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
107 participants
INTERVENTIONAL
2017-01-11
2020-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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RSV LD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
RSV (GSK3389245A) low dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
RSV MD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
RSV (GSK3389245A) middle dose formulation vaccine
2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
RSV HD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
RSV (GSK3389245A) high dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Placebo LD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Placebo MD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Placebo HD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Interventions
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RSV (GSK3389245A) low dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
RSV (GSK3389245A) middle dose formulation vaccine
2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
RSV (GSK3389245A) high dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Placebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
* A male or female between, and including, 12 and 23 months at the time of the first vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Seropositive for RSV as determined by IBL International kit.
* Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain)
* 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 0), or planned use during the study period.
* Any medical condition that in the judgment of the investigator would make IM injection unsafe.
* 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, or equivalent. Inhaled and 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 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.
* Serious chronic illness.
* Major congenital defects.
* History of any neurological disorders or seizures.
* History of or current autoimmune disease.
* History of recurrent wheezing.
* History of chronic cough.
* Previous hospitalization for respiratory illnesses.
* History of thrombocytopenia.
* History of anemia.
* Previous, current or planned administration of Synagis.
* Neurological complications following any prior vaccination.
* Born to a mother known or suspected to be 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 likely to be exacerbated by any component of the vaccine.
* Hypersensitivity to latex.
* Current severe eczema.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be axillary.
* Clinically significant upper respiratory tract infection
* Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
* Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
* Any other conditions that the investigator judges may interfere with study procedures or 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.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject 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.
12 Months
23 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Frederick, Maryland, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Sioux Falls, South Dakota, United States
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Perugia, Umbria, Italy
GSK Investigational Site
México, , Mexico
GSK Investigational Site
David, Chiriquí Province, Panama
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Dębica, , 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
Valencia, , Spain
GSK Investigational Site
Hsinchu, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taoyuan District, , Taiwan
Countries
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References
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Diez-Domingo J, Saez-Llorens X, Rodriguez-Weber MA, Epalza C, Chatterjee A, Chiu CH, Lin CY, Berry AA, Martinon-Torres F, Baquero-Artigao F, Langley JM, Ramos Amador JT, Domachowske JB, Huang LM, Chiu NC, Esposito S, Moris P, Lien-Anh Nguyen T, Nikic V, Woo W, Zhou Y, Dieussaert I, Leach A, Gonzalez Lopez A, Vanhoutte N. Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. J Infect Dis. 2023 May 29;227(11):1293-1302. doi: 10.1093/infdis/jiac481.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000117-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
204838
Identifier Type: -
Identifier Source: org_study_id