CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04090658
NCT04090658Phase 1Completed
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Phase I, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK's Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Japanese Subjects Aged 60-80 Years

GlaxoSmithKline·interventional·Posted Sep 16, 2019·Updated Feb 25, 2022

In Brief

A Phase 1 clinical trial evaluating RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 16, 2019
Enrollment StartSep 25, 2019
Primary CompletionJan 10, 2020
Study CompletionDec 11, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.8 years ago

Interventions

RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01Bbiological

Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.

Placebodrug

Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.