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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Key facts

Study ID

NCT02927873

Run by

GlaxoSmithKline

People needed

107

Starts

2017-01-11

Expected to finish

2020-11-26

Last updated by the study team

2021-10-28

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

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 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.

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 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.

Where it is running

• 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, Taiwan

Full record on ClinicalTrials.gov

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