Influenza Clinical Trial
Official title:
Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
Verified date | April 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Primary Objective:
To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the
package insert for vaccine-naïve young children) to the investigational and control groups.
Observational Objective:
To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers
(following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among
the investigational and control groups.
Status | Completed |
Enrollment | 394 |
Est. completion date | December 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Months to 9 Months |
Eligibility |
Inclusion Criteria : - Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion. - Born at full term of pregnancy (= 36 weeks) with a birth weight = 2.5 kg. - Considered to be in good health on the basis of reported medical history and history-directed physical examination. - Available for the duration of the study. - Parent/guardian willing and able to provide informed consent. - Parent/guardian able to attend all scheduled visits and comply with all trial procedures. - Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample. 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. - Receipt of any vaccine in the 7 days prior to enrollment. - An acute illness with fever (rectal temperature = 38.0 °C [or = 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment). - Known bleeding disorder. - Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 that could interfere with trial conduct or completion. - Known HIV-positive or HBsAg-positive mother. - Known HIV, hepatitis B (HBsAg), or hepatitis C infection. - Blood or blood-derived products received in the past 2 months. - 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. |
Allocation: 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 | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer = 40 Post-vaccination With Fluzone® (Seroprotection). | Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers = 40 |
21 days post-vaccination 2 | No |
Other | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of = 10 That Had a Titer of = 40 Post-vaccination With Fluzone® (Seroconversion). | Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a = 4-fold increases in titer from pre- to post-vaccination. | 21 days post-vaccination 2 | No |
Other | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. | 21 days post-vaccination 2 | No |
Primary | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability. | Day 0 to Day 7 post-vaccination | Yes |
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