Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: 2007-2008 Influenza Virus Vaccine (Biological); 2007-2008 Influenza Virus Vaccine (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Pasteur, a Sanofi Company Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.
Summary
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from
healthy children receiving the 2007-2008 formulation of the inactivated, split-virion
influenza vaccine Fluzone® for further study.
Clinical Details
Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
Eligibility
Minimum age: 6 Months.
Maximum age: 35 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
- 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/legal acceptable representative is willing and able to provide informed
consent.
- Parent/legal acceptable representative is willing and able to meet protocol
requirements.
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2. 5 kg (5. 5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the
vaccine.
- An acute illness with or without fever (For infants/toddlers: temperature ≥ 100. 4°F
rectal; For children: temperature ≥ 99. 5°F oral/axillary) in the 72 hours preceding
enrollment in the trial (Enrollment may be deferred).
- Clinically significant findings in vital signs or review of systems (Investigator
judgment; defer or exclude).
- Participation in any other interventional clinical trial within 30 days prior to
enrollment or planned 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 personal 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.
- Received any vaccinations within the preceding 14 days (enrollment may be deferred).
Locations and Contacts
Norfolk, Virginia, United States
Additional Information
Starting date: October 2007
Last updated: January 17, 2014
|