FBP00001: Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Study duration per participant is approximately 90 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Quadrivalent RIV with H3 strain 1 1 injection of Quadrivalent RIV containing H3 strain 1 |
Biological: Quadrivalent RIV with H3 strain 1
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
|
| Experimental: Quadrivalent RIV with H3 strain 2 1 injection of Quadrivalent RIV containing H3 strain 2 |
Biological: Quadrivalent RIV with H3 strain 2
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
|
| Experimental: Quadrivalent RIV with H3 strain 3 1 injection of Quadrivalent RIV containing H3 strain 3 |
Biological: Quadrivalent RIV with H3 strain 3
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
|
| Experimental: Quadrivalent RIV with H3 strain 4 1 injection of Quadrivalent RIV containing H3 strain 4 |
Biological: Quadrivalent RIV with H3 strain 4
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
|
| Active Comparator: Quadrivalent RIV Control 1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain |
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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 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 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
- 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]
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 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]
Eligibility Criteria
Criteria
Inclusion criteria :
-
Aged 18 to 30 years on the day of inclusion
-
Informed consent form has been signed and dated
-
Able to attend all scheduled visits and to comply with all study procedures
Exclusion criteria:
-
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
-
Have any diagnosis, current or past, of chronic pulmonary diseases including asthma, cystic fibrosis and chronic pulmonary obstructive disease
-
Have taken high-dose inhaled corticosteroids within 6 months prior to study vaccination
-
Body Mass Index of 40 or higher
-
History of cardiac disease such as congenital heart disease, heart failure, coronary artery disease (except isolated hypertension)
-
Health care personnel in inpatient and outpatient care settings, medical emergency-response workers, employees of nursing home and long-term care facilities who have contact with patients or residents and students in these professions who will have contact with patients
-
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F [≥ 38.0 C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
-
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
-
Personal or family history of Guillain-Barré syndrome
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 8400002 | Hollywood | Florida | United States | 33024 |
| 2 | Investigational Site Number 8400001 | Rochester | New York | United States | 14609 |
| 3 | Investigational Site Number 8400003 | Mount Pleasant | South Carolina | United States | 29464 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FBP00001
- U1111-1223-4988