Clinical trial NCT03546192: Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
Official title: Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Influenza virus vaccine
Fluzone® Quadrivalent Influenza Vaccine (No Preservative)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were enrolled in two age groups: participants aged 18 to 60 years and participants aged 61 years or older.
Primary purpose: PREVENTION

Brief summary: The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older.

The objectives were:

* To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96
* To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
* To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation

Detailed description: All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit.

Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants were \>= 18 years of age on the day of inclusion .
* Informed consent form had been signed and dated.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* History of serious adverse reaction to any influenza vaccine.
* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2.
* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
* Self-reported thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
* Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) .
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination).
* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
* Personal history of Guillain-Barré syndrome.
* 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).
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion .
* Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the participant. (No screening procedures were implemented.)
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38°C) on the day of vaccination. 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 an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.

Primary outcomes:
measure: Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
timeFrame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
measure: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
timeFrame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
measure: Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
timeFrame: Day 0 (pre-vaccination), Day 21 (Post-vaccination)
measure: Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
timeFrame: 21 days post-vaccination
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions
timeFrame: Within 7 days after vaccination
measure: Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance
timeFrame: Within 3 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Sanofi Pasteur Investigational Site 002
city: Manila
country: Philippines
facility: Sanofi Pasteur Investigational Site 003
city: Quezon City
country: Philippines
facility: Sanofi Pasteur Investigational Site 001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Montalban C, Montellano MB, Santos J, Lavis N. Immunogenicity and safety of the 2015 Southern Hemisphere formulation of a split-virion inactivated quadrivalent vaccine. Hum Vaccin Immunother. 2018 Mar 4;14(3):593-595. doi: 10.1080/21645515.2017.1377378. Epub 2017 Oct 30.