Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

NCT00258817 | Completed Phase 4 Results

• 1 other identifier: GRC26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

Conditions

Influenza

Keywords

Fluzone®; Influenza Virus Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination

  GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)

  Day 14 post-vaccination

Other Outcomes (2)

• Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1

  0 to 3 days post-vaccination 1

• Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2

  0 to 3 days post-vaccination 2

Study Arms (2)

Influenza Virus Vaccine Naïve

EXPERIMENTAL

Subjects have never received Influenza virus vaccine in the past

Biological: Influenza Virus Vaccine (Fluzone®)

Influenza Virus Vaccine-primed

EXPERIMENTAL

Subjects have received Influenza virus vaccine in the past

Biological: Influenza Virus Vaccine (Fluzone®)

Interventions

Influenza Virus Vaccine (Fluzone®) BIOLOGICAL

0.25 mL, Intramuscular (Day 0 and Day 28)

Also known as: Fluzone®

Influenza Virus Vaccine Naïve

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.

You may not qualify if:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• Documented history of influenza infection.
• An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) 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 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

• Clinical Trials

  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

Study Record Dates

• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: August 1, 2007
• Last Updated: April 14, 2016
• Results First Posted: March 25, 2009

Record last verified: 2016-04

Locations

US (1)