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 | Completed Phase 1 FDA Drug

• 2 other identifiers: FBP00001U1111-1223-4988
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Influenza

Outcome Measures

Primary Outcomes (9)

• Number of participants with immediate adverse events

  Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

  Within 30 minutes after vaccination

• Number of participants with solicited injection site or systemic reactions

  Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia

  From Day 0 to Day 7

• Number of participants with unsolicited adverse events

  Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions

  From Day 0 to Day 28

• Number of participants with serious adverse events

  Serious adverse events are collected throughout the study

  From Day 0 to Day 90

• Number of participants with adverse events of special interest

  Adverse events of special interest are collected throughout the study

  From Day 0 to Day 90

• HAI antibody titers against HA influenza antigens in quadrivalent RIV control group

  Influenza vaccine antigens are measured by HAI assay

  From Day 0 to Day 90

• Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group

  Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28

  From Day 0 to Day 90

• Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group

  Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28

  Day 28

• Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group

  Influenza vaccine antigens are measured by HAI assay

  From Day 0 to Day 90

Secondary Outcomes (6)

• 2-fold and 4-fold increase in SN antibody titers against HA influenza antigens in quadrivalent RIV control group

  From Day 0 to Day 90

• HAI and SN antibody titers against influenza H3 antigens

  From Day 0 to Day 90

• Individual ratio of HAI and SN titers against influenza H3 antigens

  From Day 0 to Day 90

• Number of participants with seroconversion to influenza H3 antigens

  Day 28

• Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens

  From Day 0 to Day 90

Study Arms (5)

Quadrivalent RIV with H3 strain 1

EXPERIMENTAL

1 injection of Quadrivalent RIV containing H3 strain 1

Biological: Quadrivalent RIV with H3 strain 1

Quadrivalent RIV with H3 strain 2

EXPERIMENTAL

1 injection of Quadrivalent RIV containing H3 strain 2

Biological: Quadrivalent RIV with H3 strain 2

Quadrivalent RIV with H3 strain 3

EXPERIMENTAL

1 injection of Quadrivalent RIV containing H3 strain 3

Biological: Quadrivalent RIV with H3 strain 3

Quadrivalent RIV with H3 strain 4

EXPERIMENTAL

1 injection of Quadrivalent RIV containing H3 strain 4

Biological: Quadrivalent RIV with H3 strain 4

Quadrivalent RIV Control

ACTIVE COMPARATOR

1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain

Biological: Quadrivalent RIV with 2018-2019 NH H3 strain

Interventions

Quadrivalent RIV with H3 strain 1 BIOLOGICAL

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

Quadrivalent RIV with H3 strain 1

Quadrivalent RIV with H3 strain 2 BIOLOGICAL

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

Quadrivalent RIV with H3 strain 2

Quadrivalent RIV with H3 strain 3 BIOLOGICAL

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

Quadrivalent RIV with H3 strain 3

Quadrivalent RIV with H3 strain 4 BIOLOGICAL

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

Quadrivalent RIV with H3 strain 4

Quadrivalent RIV with 2018-2019 NH H3 strain BIOLOGICAL

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

Quadrivalent RIV Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all study procedures

You may not qualify if:

• Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 12 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
• Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
• Previous vaccination against influenza in the previous influenza season (2018-2019) with any licensed or investigational influenza vaccine
• Previous vaccination against influenza in the 2019-2020 season with any licensed influenza vaccine
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy
• History of influenza infection during the 2018-2019 or 2019-2020 influenza season, confirmed by laboratory tests (including rapid tests)
• Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
• Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination based on Investigator's judgement
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Alcohol abuse or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion or predispose to complications associated with influenza infection

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Research Centers of America Site Number : 8400002

Hollywood, Florida, 33024, United States

Location

Rochester Clinical Research, Inc. Site Number : 8400001

Rochester, New York, 14609, United States

Location

Coastal Carolina Research Center Site Number : 8400003

North Charleston, South Carolina, 29405, United States

Location

Related Links

• FBP00001 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: November 6, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (3)