CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 833 enrolled
Drug / intervention
FLU-Q-PAN H7N9 Formulation 1 +5 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/NCT04789577
NCT04789577Phase 2Completed

A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older

GlaxoSmithKline·interventional·Posted Mar 9, 2021·Updated Oct 10, 2023

In Brief

A Phase 2 clinical trial evaluating FLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2, and 4 other interventions for Influenza, Human. Completed, enrolled 833 participants across 8 sites.

Detailed Summary

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMar 9, 2021
Enrollment StartMar 16, 2021
Primary CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.3 years ago

Interventions

FLU-Q-PAN H7N9 Formulation 1biological

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 2biological

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.

FLU-Q-PAN H7N9 Formulation 3biological

Participants received two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.

AS03Bbiological

Participants received two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.

AS03Abiological

Participants received two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.

Placebodrug

Participants received two doses of Placebo by intramuscular injection in the non-dominant arm.