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Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age

NCT04144179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-07-29

No results posted yet for this study

Summary

The primary objectives of the study are:

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

The secondary objectives of the study 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 HAI and SN antibody responses in each group against each of the H3 antigens.
* To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.

Conditions

Interventions

BIOLOGICAL

Quadrivalent RIV with H3 strain 1

Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 2

Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 3

Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with H3 strain 4

Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular

BIOLOGICAL

Quadrivalent RIV with 2018-2019 NH H3 strain

Pharmaceutical form: Pre-filled single-dose vial 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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2020-02-24
Completion
2020-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04144179 on ClinicalTrials.gov