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

NCT00885105 | Completed Phase 3 Results

• 1 other identifier: GRC32
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Influenza

Keywords

Fluzone® vaccine; Influenza

Outcome Measures

Primary Outcomes (1)

• Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.

  Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.

  Day 28 Post-vaccination

Other Outcomes (5)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.

  Day 28 Post-vaccination

• Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.

  Day 28 Post-vaccination

• Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.

  Day 28 post-vaccination

Study Arms (2)

Fluzone® Vaccine-Primed Group

EXPERIMENTAL

Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)

Biological: Influenza Virus Vaccine

Influenza Vaccine-Naive Group

ACTIVE COMPARATOR

Participants who have never received influenza vaccine (and not in Study GRC27)

Biological: Influenza Virus Vaccine

Interventions

Influenza Virus Vaccine BIOLOGICAL

0.25 mL, Intramuscular

Also known as: Fluzone® 2005-2006 Pediatric Formulation

Fluzone® Vaccine-Primed Group

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (6)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Marietta, Georgia, 30062, United States

Location

Unknown Facility

Durham, North Carolina, 27704, United States

Location

Unknown Facility

Dayton, Ohio, 45404, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Seattle, Washington, 98040, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: October 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 14, 2016
• Results First Posted: January 1, 2010

Record last verified: 2016-04

Locations

US (6)