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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children
Pediatric Infectious Disease Journal, Volume 28, No. 5, Year 2009
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Description
BACKGROUND: We investigated the efficacy and safety of 1 versus 2 doses of live attenuated influenza vaccine (LAIV) in influenza vaccine-naive children aged 6 to <36 months. PATIENTS/METHODS: Subjects were randomized to 1 of 4 regimens in year 1: 2 doses LAIV, 1 dose LAIV, excipient placebo, or saline placebo. In year 2, LAIV recipients were to receive 1 dose of LAIV and placebo recipients were to receive saline placebo. Because of an unintended treatment allocation error in year 2, 1 block of subjects who were randomized to LAIV received saline placebo and 1 block who were randomized to placebo received LAIV. RESULTS: In year 1, vaccine efficacy versus placebo among recipients of 2 and 1 doses of LAIV was 73.5% and 57.7%, respectively, against antigenically similar strains. In year 2, absolute efficacy of a single dose of LAIV was 73.6% and 65.2%, respectively, in recipients of 2 and 1 doses of LAIV in year 1. Year 2 efficacy was 57.0% in subjects who received 2 doses of LAIV in year 1 and placebo in year 2. Safety and tolerability of LAIV were consistent with previous studies. Reactogenicity was similar between placebo groups. Seroconversion rates were significantly higher in the 2-dose versus the 1-dose LAIV group in year 1 and in both LAIV groups versus placebo in years 1 and 2. CONCLUSIONS: One dose of LAIV provided clinically significant protection against influenza in young children previously unvaccinated against influenza; 2 doses provided additional protection. Protection after 2 doses in year 1 persisted through a second season without revaccination. LAIV excipients were not a major contributor to reactogenicity. These benefits provide support for increased use of LAIV in children ≥2 years of age. © 2009 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Neto, Humberto Bracco
Brazil, Sao Paulo
Universidade Federal de São Paulo
Farhat, Calil Kairalla
Brazil, Sao Paulo
Universidade Federal de São Paulo
Tregnaghi, Miguel Wenceslao
Argentina, Cordoba
Hospital Infantil Municipal de Cordoba
Madhi, Shabir A.
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
South Africa, Johannesburg
University of the Witwatersrand
Razmpour, Ahmad
United States, Pearl River
Pfizer Research Pearl River
Palladino, Giuseppe
United States, Pearl River
Pfizer Research Pearl River
Small, Margaret G.
United States, Pearl River
Pfizer Research Pearl River
Gruber, William C.
United States, Pearl River
Pfizer Research Pearl River
Forrest, Bruce D.
United States, Pearl River
Pfizer Research Pearl River
Statistics
Citations: 109
Authors: 9
Affiliations: 5
Identifiers
Doi:
10.1097/INF.0b013e31819219b8
ISSN:
08913668
e-ISSN:
15320987
Research Areas
Maternal And Child Health