Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza virus vaccine (Pediatric formulation) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 33 |
| Study Start Date: | September 2003 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
|
Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Name: Fluzone®
|
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®.
Eligibility| Ages Eligible for Study: | 6 Months to 36 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
More Information
Additional Information:
Publications:
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00836953 History of Changes |
| Other Study ID Numbers: | GRC17 |
| Study First Received: | February 3, 2009 |
| Results First Received: | July 20, 2009 |
| Last Updated: | November 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Influenza Fluzone® Children |
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 June 18, 2013