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A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older

NCT04789577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 833

Last updated 2023-10-10

Study results available
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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.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

FLU-Q-PAN H7N9 Formulation 1

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

BIOLOGICAL

FLU-Q-PAN H7N9 Formulation 2

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

BIOLOGICAL

FLU-Q-PAN H7N9 Formulation 3

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

BIOLOGICAL

AS03B

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

BIOLOGICAL

AS03A

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-09-12
Completion
2022-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789577 on ClinicalTrials.gov