MedTrace Logo

Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects

NCT04451954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-09-17

No results posted yet for this study

Summary

The primary objectives of the study are:

* To describe the safety profile of the different formulations in all participants
* To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives are:

* To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
* To describe SN antibody responses in each group against each of the H3 antigens.
* To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.
* To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

Conditions

  • Influenza Immunisation
  • Healthy Volunteers

Interventions

BIOLOGICAL

Quadrivalent RIV with H3 strain 1

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 1 and adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 2

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 2 and adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with 2018-2019 NH H3 strain

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2021-09-20
Completion
2021-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04451954 on ClinicalTrials.gov