Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03546192
• Date of registration: 22/05/2018
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
• Scientific title: Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
• Date of first enrolment: June 17, 2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03546192
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Philippines

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur, a Sanofi Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Fluzone Quadrivalent Influenza Vaccine

Primary Outcome(s)

Number of Participants Reporting Solicited Injection Site and Systemic Reactions [Time Frame: Within 7 days after vaccination]

Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance [Time Frame: Within 3 days after vaccination]

Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) [Time Frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)]

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) [Time Frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)]

Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens [Time Frame: 21 days post-vaccination]

Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies [Time Frame: Day 0 (pre-vaccination), Day 21 (Post-vaccination)]

Secondary ID(s)

GRC85

U1111-1143-9256

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03546192