Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age (GRC28)
Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2005-2006 Formulation) Among Healthy Children 6 to 12 Weeks of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone®, sanofi pasteur 2005-6 pediatric formulation) (N=915) or placebo (N=460) 1 month apart, along with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. Hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.
Results: No significant differences were seen between TIV and placebo groups for any safety outcomes. Fever ≥38oC rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of TIV vs placebo recipients. Serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of TIV and 1.5% of placebo recipients; only one (hypersensitivity reaction in a TIV recipient) was considered vaccine-related. Significantly increased antibody responses (p<0.001) were seen against all 3 strains in TIV recipients by titer ≥ 1:40 or geometric mean titer (GMT) (p<0.001). Altogether, 50% of infants had antibody titers ≥ 1:40 for H1N1, 86% for H3N2, and 11% for B compared with 7%, 10%, and 0.3% in the placebo group. The reciprocal GMT for influenza recipients was 33, 95, and 11 for H1N1, H3N2, and B vs. 7, 9, and 5 for placebo recipients. Over 90% of infants who received TIV had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group.
Conclusions: TIV administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- Seattle Children's Hospital and Regional Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 42 to 84 days on the day of inclusion
- Full term (born at >=36 weeks with birth weight >=2.5 kg
- Considered to be in good health
- Parental consent obtained and available
- Available for the study duration (6 months)
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins
- Previous history of influenza vaccination or disease
- Receipt of any vaccine other than Hepatitis B prior to enrollment
- Acute illness with rectal temperature >= 38.0 (defer enrollment)
- Known bleeding disorder
- Participation in other interventional clinical trial within 30 days prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age
|
Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines.
Second dose administered 4 weeks later.
|
|
Experimental: 2
2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age
|
Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines.
Second dose administered 4 weeks later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To demonstrate the safety of Fluzone vaccine administered to 2-month old children
Time Frame: within 6 months
|
within 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Janet A Englund, MD, Seattle Children's Hospital
Publications and helpful links
General Publications
- Englund JA, Walter EB, Black S, et al. Safety and Immunogenicity of Fluzone Trivalent Inactivated Influenza Vaccine (TIV) in Infants 6-12 Weeks of Age. Presented at Infectious Disease Society of America (IDSA), Toronto, Oct. 14, 2006
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05065501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.