Immunogenicity Trial of 3 Influenza Vaccines

NCT05479370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2025-10-31

No results posted yet for this study

Summary

This study is a prospective randomised trial of 3 influenza vaccine formulations with different manufacturing processes: 1) egg-grown (QIV-E); 2) cell-grown (QIV-C); and 3) recombinant protein (QIV-R). The main objective is to compare the antibody responses following influenza vaccination among these 3 vaccines to determine whether recombinant vaccines offer superior protection over standard egg or cell-based formulations. The attenuating effects of prior vaccination on vaccine immunogenicity will also be evaluated.

Hypothesis: Vaccination with recombinant vaccine results in better antibody responses, particularly against A(H3N2) viruses, than either standard egg-grown vaccines or cell-grown vaccines.

Conditions

  • Influenza Vaccination

Interventions

BIOLOGICAL

Flublok Quadrivalent vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Fluarix Quadrivalent vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Flucelvax Quadrivalent vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Barnaby Young, Dr · National Centre for Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2023-04-14
Completion
2024-02-06
FDA Drug
Yes

Countries

  • Singapore

Study Locations

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Entities

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 NCT05479370 on ClinicalTrials.gov