Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

NCT00561002 | Completed Phase 4 Results

• 1 other identifier: GRC38
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Conditions

Influenza

Keywords

Influenza Vaccine; Influenza Virus; Orthomyxoviridae Infections; Fluzone®

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation

  Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.

  Days 0-3 post-dose

Other Outcomes (3)

• Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination

  Day 0 and Day 14 after last dose of Fluzone

• Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)

  Day 14 post-vaccination

• Seroconversion Rates for Each Influenza Antigen Post-Vaccination

  Day 14 post-vaccination

Study Arms (2)

Influenza vaccine Naive/Inadequately Primed

EXPERIMENTAL

Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.

Biological: 2007-2008 Influenza Virus Vaccine

Influenza Vaccine Primed

EXPERIMENTAL

Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.

Biological: 2007-2008 Influenza Virus Vaccine

Interventions

2007-2008 Influenza Virus Vaccine BIOLOGICAL

0.25 mL, Intramuscular

Also known as: Fluzone®

Influenza vaccine Naive/Inadequately Primed

Eligibility Criteria

• Age: 6 Months - 35 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 or planned 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.
• Received any vaccinations within the preceding 14 days (enrollment may be deferred).

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; 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: November 19, 2007
• First Posted: November 20, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 14, 2016
• Results First Posted: August 27, 2009

Record last verified: 2016-04

Locations

US (1)