Immunogenicity Trial of 3 Influenza Vaccines
NCT05479370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366
Last updated 2025-10-31
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
-
A*Star
collaborator OTHER - collaborator OTHER
- collaborator INDUSTRY
-
Tan Tock Seng Hospital
lead OTHER
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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