Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

• ClinicalTrials.gov Identifier: NCT00755274
• Recruitment Status: Completed
• First Posted: September 18, 2008
• Results First Posted: April 1, 2010
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information

• First Submitted Date: September 16, 2008
• First Posted Date: September 18, 2008
• Results First Submitted Date: February 1, 2010
• Results First Posted Date: April 1, 2010
• Last Update Posted Date: April 14, 2016
• Study Start Date: September 2008
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2010)

• Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 [ Time Frame: Day 0 to Day 3 post-vaccination 1 ]
  Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
• Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 [ Time Frame: Day 0 to Day 3 post-vaccination 2 ]
  Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

• Original Primary Outcome Measures (submitted: September 16, 2008): Immunogenicity: To provide information concerning the immunogenicity of Fluzone® Vaccine 2008-2009 No Preservative: Pediatric Dose Formulation. [ Time Frame: Day 28 or Day 49 Post-vaccination ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: January 17, 2014)

• Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ]
• Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ]
  Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.
• Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ]
  Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.
• Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ]
  Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.
• Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [ Time Frame: Day 28 post-single dose or Day 21 post-Dose 2 ]
  Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
• Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)

Brief Summary

Primary Objective:

To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Observational Objectives:

To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.

• Detailed Description: The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Influenza
• Orthomyxoviridae Infections

Intervention

Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Other Name: Fluzone®

Study Arms

• Experimental: Group 1: Primed
  Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1
  Intervention: Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
• Experimental: Group 2: Naive/Inadequately Primed
  Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1
  Intervention: Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2009): 32
• Original Estimated Enrollment (submitted: September 16, 2008): 30
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participant is ≥ 6 months to < 5 years of age.
• Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
• Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
• Parent/legal acceptable representative is willing and able to provide informed consent.
• Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• History of severe adverse event to any influenza vaccine.
• Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
• Any vaccination scheduled between Visit 1 and Visit 2.
• Planned participation in any other interventional clinical trial during participation in the study.
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay, neurologic disorder, or seizure disorder.
• Chronic medical, congenital, or developmental disorder.
• Known Human immunodeficiency virus (HIV)-positive mother.
• Prior personal history of Guillain-Barré syndrome.
• Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00755274
• Other Study ID Numbers: GRC40
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• Study Sponsor: Sanofi Pasteur, a Sanofi Company
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Sanofi pasteur Inc.

• PRS Account: Sanofi
• Verification Date: April 2016