Study of Safety and Immunogenicity of Fluzone® in Healthy Children
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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 | Intervention | Phase |
---|---|---|
Influenza |
Biological: Influenza Vaccine 2004-2005 Paediatric Formulation |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation [ Time Frame: Days 0-3 Post-dose ] [ Designated as safety issue: Yes ]
Enrollment: | 30 |
Study Start Date: | September 2004 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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®
|
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).
Ages Eligible for Study: | 6 Months to 35 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Additional Information:
No publications provided
Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
ClinicalTrials.gov Identifier: | NCT00831675 History of Changes |
Other Study ID Numbers: | GRC21 |
Study First Received: | January 28, 2009 |
Results First Received: | July 20, 2009 |
Last Updated: | November 18, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi-Aventis:
Influenza Fluzone® vaccine Infants Toddlers |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on October 18, 2012