A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

Osivax1 site in 1 country300 target enrollmentDecember 11, 2019

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Osivax
Enrollment: 300
Locations: 1
Primary Endpoint: NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.

Detailed Description

This is a Phase 2a, randomised, double-blind study in 300 adults to compare the safety and immunogenicity of OVX836 to QIV (Influvac TetraTM). One dose of OVX836 at two dose levels will be administered intramuscularly, in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine in healthy subjects aged 18-65 years.

Registry

clinicaltrials.gov

Start Date

December 11, 2019

End Date

September 7, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Osivax

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent.
•Healthy male or female subjects, as determined by medical history and medical examination.
•Between the ages of 18 and 65 years, inclusive.
•Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.

Exclusion Criteria

•Subject with a body mass index (BMI) ≥35 kg/m² on the day of vaccination.
•Previous influenza vaccination within 6 months before the day of vaccination, or planned to receive during the study duration.
•Any known or suspected immunodeficient conditions.
•Past or current history of significant autoimmune diseases, as judged by the Investigator.
•Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
•Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group \[CTFG\] as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
•Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines.
•Planning to receive other vaccines during the first 28 days following the study vaccine administration.
•Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
•History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.

Outcomes

Primary Outcomes

NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata

Time Frame: at Day 8 versus pre-injection baseline (Day 1)

Secondary Outcomes

Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza(during the whole study duration, 180 days)
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)(during the whole study duration, 180 days)
Proportion of subjects reporting Serious Adverse Events(during the whole study duration, 180 days)
Proportion of subjects reporting unsolicited Adverse Events(during 28 days after vaccine administration)
Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point in the pooled age strata and by age stratum (18-49 years; 50-65 years)(at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) using an electronic Diary(during 7 days after vaccine administration)
NP-specific IFNγ T-cell activity measured by ELISPOT in the pooled age strata and by age stratum (18-49 years; 50-65 years)(at Day 8, Day 29 and Day 180 versus pre-injection baseline (Day 1))
NP T-cell phenotype and functionality by flow cytometry in the pooled age strata and by age stratum (18-49 years; 50-65 years)(at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180)