CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 976 enrolled
Drug / intervention
RSVPreF3 OA investigational vaccine +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/NCT04841577
NCT04841577Phase 3Completed

A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above

GlaxoSmithKline·interventional·Posted Apr 12, 2021·Updated Sep 3, 2024

In Brief

A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine and FLU-QIV for Respiratory Syncytial Virus Infections. Completed, enrolled 976 participants across 14 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 years and above compared to separate administration of the vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand, Panama, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 12, 2021
Enrollment StartApr 27, 2021
Primary CompletionSep 22, 2021
Study CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.2 years ago

Interventions

RSVPreF3 OA investigational vaccinebiological

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

FLU-QIVbiological

FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.