Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00885105
First received: April 20, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.

Observational Objectives:

  • To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
  • To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
  • To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. [ Time Frame: Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.


Other Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. [ Time Frame: Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.

  • Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. [ Time Frame: Day 28 Post-vaccination ] [ Designated as safety issue: No ]

    Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).

    Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.

    The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.


  • Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).

  • Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Antibodies to polio viruses were measured by a serum neutralization assay.

  • Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. [ Time Frame: Days 0 up to 7 post-vaccination ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.


Enrollment: 242
Study Start Date: October 2005
Study Completion Date: September 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone® Vaccine-Primed Group
Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone® 2005-2006 Pediatric Formulation
Active Comparator: Influenza Vaccine-Naive Group
Participants who have never received influenza vaccine (and not in Study GRC27)
Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone® 2005-2006 Pediatric Formulation

Detailed Description:

This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.

  Eligibility

Ages Eligible for Study:   6 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
  • Available for the duration of the study.
  • Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
  • Parent/legal acceptable representative willing and able to provide informed consent.
  • Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
  • Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
  • Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
  • Previous history of influenza vaccination (Group 2 subjects only).
  • Receipt of any vaccine in the 14 days prior to enrollment.
  • An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
  • Known bleeding disorder.
  • Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this 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 that could interfere with trial conduct or completion.
  • Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
  • Known HIV, hepatitis B, or hepatitis C infection.
  • Receipt of blood or blood-derived products within the past 2 months.
  • Prior 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885105

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Georgia
Marietta, Georgia, United States, 30062
United States, North Carolina
Durham, North Carolina, United States, 27704
United States, Ohio
Dayton, Ohio, United States, 45404
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Washington
Seattle, Washington, United States, 98040
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00885105     History of Changes
Other Study ID Numbers: GRC32
Study First Received: April 20, 2009
Results First Received: September 2, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Fluzone® vaccine
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014