Influenza Clinical Trial
Official title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
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 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
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 35 Months |
Eligibility |
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. |
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 | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | 14 days post-vaccination | No | |
Other | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers =40 post-vaccination with Fluzone®. | 14 days post-vaccination | No |
Other | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | Seroconversion defined as the percentage of participants with a = 4-fold increases in titer from pre- to post-vaccination with Fluzone®. | Day 14 post-vaccination | Yes |
Primary | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | 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. |
Days 0-3 Post-dose | Yes |
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