CompletedPhase 1/2

A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults

United States1,053 participantsStarted 2019-01-21

Plain-language summary

The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion Criteria: For all subjects: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. For Part A: • A male or female between, and including, 18 and 40 years of age at the time of the first vaccination. For Part B: * A male or female between, and including, 60 and 80 years of age at the time of the first vaccination. * Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Exclusion Criteria: For all subjects: * 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, 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 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, 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. * Planned administration/administration of a vacci…

What they're measuring

Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose

Timeframe: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)

Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose

Timeframe: During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)

Number of Subjects With Any Solicited General Symptom After First Vaccination Dose

Timeframe: During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)

Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose

Timeframe: During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)

Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose

Timeframe: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)

Timeframe: At baseline and at 7 days after the first vaccine dose (Day 8)

Trial details

NCT IDNCT03814590

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-12

Results submitted2022-02-22

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infections trials