Trial to Collect Safety Data and Sera for Immunogenicity Testing

NCT00389857 | Completed Phase 4 Results

• 1 other identifier: GRC34
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Conditions

Influenza

Keywords

Influenza; Influenza Virus Vaccine; Fluzone®

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination

  GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)

  14 days post-vaccination

Other Outcomes (2)

• Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.

  0 to 3 days post-vaccination 1

• Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.

  0 to 3 days post-vaccination 2

Study Arms (2)

Influenza vaccine-naive group

EXPERIMENTAL

Participants have never received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0 and Day 28, respectively.

Biological: Influenza Virus Vaccine (Fluzone®)

Influenza vaccine-primed group

EXPERIMENTAL

Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0.

Biological: Influenza Virus Vaccine (Fluzone®)

Interventions

Influenza Virus Vaccine (Fluzone®) BIOLOGICAL

0.25 mL, Intramuscular (infant/children dose)

Also known as: Fluzone®

Influenza vaccine-naive group

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday).
• Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
• Participant is available for the duration of the study.
• Parent/legal acceptable representative is willing and able to provide informed consent.
• Parent/legal acceptable representative is willing and able to meet protocol requirements.
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

You may not qualify if:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• An acute illness with or without fever (For infants/toddlers: temperature
• ≥ 100.4 °F rectal; For children: temperature ≥ 99.5 °F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
• Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
• Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, 23510, 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 Director

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

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: April 14, 2016
• Results First Posted: March 24, 2009

Record last verified: 2016-04

Locations

US (1)