Study of Safety and Immunogenicity of Fluzone® in Healthy Children

• ClinicalTrials.gov Identifier: NCT00831675
• Recruitment Status: Completed
• First Posted: January 29, 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 of the 2004-2005 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 of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a 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 Vaccine 2004-2005 Paediatric Formulation	Phase 4

Detailed Description:

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
• Study Start Date: September 2004
• Actual Primary Completion Date: April 2006
• Actual Study Completion Date: April 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Infants <12 Months; Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine	Biological: Influenza Vaccine 2004-2005 Paediatric Formulation; 0.25 mL (Day 0 and Day 28), Intramuscular; Other Name: Fluzone®
Experimental: Toddlers ≥12 Months; Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine	Biological: Influenza Vaccine 2004-2005 Paediatric Formulation; 0.25 mL (Day 0 and Day 28), Intramuscular; Other Name: Fluzone®

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation [ Time Frame: Days 0-3 Post-dose ]

   Solicited local reactions: Erythema, bruising, induration, pain at injection site.

   Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.

Other Outcome Measures:

1. Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation [ Time Frame: 14 days post-vaccination ]
2. Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) [ Time Frame: 14 days post-vaccination ]
   Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.
3. Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) [ Time Frame: Day 14 post-vaccination ]
   Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 35 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria :

• Participant is aged ≥ 6 months to < 36 months.
• 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/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.
• Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

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 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00831675
• Other Study ID Numbers: GRC21
• First Posted: January 29, 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® vaccine; Infants; Toddlers

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs