Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Quadrivalent RIV with H3 strain 4; Biological: Quadrivalent RIV with H3 strain 3; Biological: Quadrivalent RIV with 2018-2019 NH H3 strain; Biological: Quadrivalent RIV with H3 strain 1; Biological: Quadrivalent RIV with H3 strain 2

• Registration Number: NCT04144179
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Study duration per participant is approximately 90 days.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-06
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadrivalent RIV with H3 strain 4	Quadrivalent RIV with H3 strain 4	1 injection of Quadrivalent RIV containing H3 strain 4
Quadrivalent RIV with H3 strain 3	Quadrivalent RIV with H3 strain 3	1 injection of Quadrivalent RIV containing H3 strain 3
Quadrivalent RIV Control	Quadrivalent RIV with 2018-2019 NH H3 strain	1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain
Quadrivalent RIV with H3 strain 1	Quadrivalent RIV with H3 strain 1	1 injection of Quadrivalent RIV containing H3 strain 1
Quadrivalent RIV with H3 strain 2	Quadrivalent RIV with H3 strain 2	1 injection of Quadrivalent RIV containing H3 strain 2

Primary Outcome Measures

Name	Time	Method
Number of participants with immediate adverse events	Within 30 minutes after vaccination	Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions	From Day 0 to Day 7	Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Number of participants with unsolicited adverse events	From Day 0 to Day 28	Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
HAI antibody titers against HA influenza antigens in quadrivalent RIV control group	From Day 0 to Day 90	Influenza vaccine antigens are measured by HAI assay
Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group	Day 28	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
Number of participants with serious adverse events	From Day 0 to Day 90	Serious adverse events are collected throughout the study
Number of participants with adverse events of special interest	From Day 0 to Day 90	Adverse events of special interest are collected throughout the study
Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group	From Day 0 to Day 90	Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group	From Day 0 to Day 90	Influenza vaccine antigens are measured by HAI assay

Secondary Outcome Measures

Name	Time	Method
HAI and SN antibody titers against influenza H3 antigens	From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens	Day 28	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
Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens	From Day 0 to Day 90
2-fold and 4-fold increase in SN antibody titers against influenza H3 antigens	From Day 0 to Day 90
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
Individual ratio of HAI and SN titers against influenza H3 antigens	From Day 0 to Day 90	Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28

Trial Locations

Locations (3)

Investigational Site Number 8400001; 🇺🇸 Rochester, New York, United States

Investigational Site Number 8400003; 🇺🇸 Mount Pleasant, South Carolina, United States

Investigational Site Number 8400002; 🇺🇸 Hollywood, Florida, United States