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

• ClinicalTrials.gov Identifier: NCT00836953
• Recruitment Status: Completed
• First Posted: February 4, 2009
• Results First Posted: August 27, 2009
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Influenza virus vaccine (Pediatric formulation)	Phase 4

Detailed Description:

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
• Study Start Date: September 2003
• Actual Primary Completion Date: January 2004
• Actual Study Completion Date: July 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Group; Participants received 2 doses of Fluzone® vaccine	Biological: Influenza virus vaccine (Pediatric formulation); 0.25 mL, Intramuscular; Other Name: Fluzone®

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-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.

Other Outcome Measures:

1. Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) [ Time Frame: Day 0 and Day 14 after Dose 2 ]
   Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
2. Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) [ Time Frame: Day 0 and Day 14 Post-dose 2 ]
   Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 36 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria :

• 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.

Exclusion Criteria :

• 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.

Contacts and Locations

Locations

United States, Virginia

Norfolk, Virginia, United States, 23510

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

Related Info 

Publications of Results:

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.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00836953
• Other Study ID Numbers: GRC17
• First Posted: February 4, 2009
• Results First Posted: August 27, 2009
• Last Update Posted: April 14, 2016
• Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Influenza; Fluzone®; Children

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases