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

NCT03546192 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC85U1111-1143-9256
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Conditions

Influenza

Keywords

Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)

  Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer \>=40 (1/dilution \[dil\]) at pre-vaccination and post-vaccination.

  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)

  Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.

  Day 0 (pre-vaccination) and Day 21 (post-vaccination)

• Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

  Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.

  Day 0 (pre-vaccination), Day 21 (Post-vaccination)

• Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens

  Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and a post-vaccination titer \>= 40 (1/dil). Significant increase was defined as a pre-vaccination titer \>= 10 (1/dil) and \>= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.

  21 days post-vaccination

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions

  A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: \>=25 mm to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.

  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

  Solicited reactions listed in the CHMP note for guidance included: injection site induration \>= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature \> 38.0°C for at least one day, malaise, and shivering.

  Within 3 days after vaccination

Study Arms (2)

Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years

EXPERIMENTAL

Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.

Biological: Fluzone Quadrivalent Influenza Vaccine

Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older

EXPERIMENTAL

Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.

Biological: Fluzone Quadrivalent Influenza Vaccine

Interventions

Fluzone Quadrivalent Influenza Vaccine BIOLOGICAL

0.5-mL, Intramuscular, SH 2015 formulation

Also known as: Fluzone® Quadrivalent Influenza Vaccine

Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years; Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form had been signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Sanofi Pasteur Investigational Site 002

Manila, Philippines

Location

Sanofi Pasteur Investigational Site 003

Manila, Philippines

Location

Sanofi Pasteur Investigational Site 001

Quezon City, Philippines

Location

Related Publications (1)

• 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.

  PMID: 28933626 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

800-633-1610 ext 1#

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were enrolled in two age groups: participants aged 18 to 60 years and participants aged 61 years or older.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: June 17, 2015
• Primary Completion: July 17, 2015
• Study Completion: July 17, 2015
• Last Updated: March 29, 2022
• Results First Posted: August 1, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

PH (3)