Influenza Clinical Trial
Official title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
Verified date | April 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
Status | Completed |
Enrollment | 31 |
Est. completion date | July 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 36 Months |
Eligibility |
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 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 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). | 0 to 3 days post-vaccination 1 | Yes |
Other | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). Note: Influenza vaccine-primed group did not receive vaccination 2 |
0 to 3 days post-vaccination 2 | Yes |
Primary | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group) |
14 days post-vaccination | No |
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