Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

NCT00836953 | Completed Phase 4 Results

• 1 other identifier: GRC17
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Conditions

Influenza

Keywords

Influenza; Fluzone®; Children

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination

  Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.

  Day 0 to 3 post-vaccination

Other Outcomes (2)

• Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)

  Day 0 and Day 14 after Dose 2

• Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)

  Day 0 and Day 14 Post-dose 2

Study Arms (1)

Study Group

EXPERIMENTAL

Participants received 2 doses of Fluzone® vaccine

Biological: Influenza virus vaccine (Pediatric formulation)

Interventions

Influenza virus vaccine (Pediatric formulation) BIOLOGICAL

0.25 mL, Intramuscular

Also known as: Fluzone®

Study Group

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 6 months to \< 36 months.
• Considered to be in good health on the basis of reported medical history and limited physical examination.
• Available for the duration of the study (44 days +4 days).
• Parent/guardian is willing and able to provide informed consent.
• Parent/guardian is willing and able to meet protocol requirements.

You may not qualify if:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• Previous history of influenza vaccination or 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 (defer enrollment).
• Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
• Participation in any other 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 Publications (1)

• Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. doi: 10.1097/01.inf.0000180978.66362.d9.

  PMID: 16220095 RESULT

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: September 1, 2003
• Primary Completion: January 1, 2004
• Study Completion: July 1, 2004
• Last Updated: April 14, 2016
• Results First Posted: August 27, 2009

Record last verified: 2016-04

Locations

US (1)