Inactivated Influenza Vaccine
Conditions
Keywords
influenza vaccine, infants, safety, immunogenicity
Brief summary
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.
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.
Interventions
BIOLOGICAL2005-2006 trivalent inactivated influenza vaccine
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.
Sponsors
Sanofi Pasteur, a Sanofi Company
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 84 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the safety of Fluzone vaccine administered to 2-month old children | within 6 months |
Countries
United States
Outcome results
None listed