Safety and Immunogenicity of Trivalent Inactivated Influenza Vaccine in Infants
| Autor: | Janet A, Englund, Emmanuel, Walter, Steven, Black, Mark, Blatter, Jack, Nyberg, Frederick L, Ruben, Michael D, Decker, Kenneth, Zollo |
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| Rok vydání: | 2010 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Influenza vaccine Population Immunization Secondary Placebo-controlled study Antibodies Viral Placebo law.invention Placebos Double-Blind Method Randomized controlled trial law Internal medicine Influenza Human medicine Humans Adverse effect education education.field_of_study business.industry Vaccination Infant Hemagglutination Inhibition Tests United States Infectious Diseases Vaccines Inactivated Influenza Vaccines Concomitant Pediatrics Perinatology and Child Health Immunology business |
| Zdroj: | Pediatric Infectious Disease Journal. 29:105-110 |
| ISSN: | 0891-3668 |
| DOI: | 10.1097/inf.0b013e3181b84c34 |
| Popis: | 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 ≥38°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 ≥ 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. |
| Databáze: | OpenAIRE |
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