1. Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study.
- Author
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Englund JA, Walter E, Black S, Blatter M, Nyberg J, Ruben FL, and Decker MD
- Subjects
- Antibodies, Viral blood, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Hemagglutination Inhibition Tests, Humans, Immunization, Secondary methods, Infant, Placebos administration & dosage, United States, Vaccination methods, Vaccines, Inactivated adverse effects, Vaccines, Inactivated immunology, Influenza Vaccines adverse effects, Influenza Vaccines immunology, Influenza, Human prevention & control
- Abstract
Background: Infants less than 6 months of age are at high risk for influenza disease and influenza-related complications, but no vaccine is licensed for this population., Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6 to 12 weeks of age. Subjects received 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone, sanofi pasteur; N = 915) or placebo (N = 460) 1 month apart in combination with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following vaccination, and unsolicited adverse events for 28 days. 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 outcome. Fever > or =38 degrees C within 3 days of vaccination was seen in 11.2% versus 11.7% of TIV versus placebo recipients. Serious adverse events within 28 days were reported in 1.9% of TIV and 1.5% of placebo recipients. Antibody responses to childhood vaccines were similar in both groups. Increased influenza-specific antibody responses in TIV recipients compared with placebo recipients were seen against all 3 strains in TIV recipients (P < 0.001), with better responses to influenza A strains noted. Reciprocal geometrical mean titer to H1N1, H3N2, and B were 33, 95, and 11 in TIV recipients versus 7, 9, and 5 for placebo recipients. Over 90% of TIV recipients had antibody > or =1:40 for at least 1 vaccine strain and 49.6% for 2 strains, versus 16.4% and 0.9% in placebo-recipients., Conclusions: TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.
- Published
- 2010
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