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Efficacy and Safety of a Live Attenuated, Cold-Adapted Influenza Vaccine, Trivalent Against Culture-Confirmed Influenza in Young Children in Asia

Tam, John S. PhD*; Capeding, Maria Rosario Z. MD†‡; Lum, Lucy Chai See MD§; Chotpitayasunondh, Tawee MD∥; Jiang, Zaifang MD¶; Huang, Li-Min MD, PhD#**; Lee, Bee Wah MD††; Qian, Yuan MD‡‡; Samakoses, Rudiwilai MD§§; Lolekha, Somsak MD, PhD∥∥; Rajamohanan, K Pillai MD, PhD, MSEpid¶¶; Narayanan, S Noel MD, DCH, MRCP, FRCP¶¶; Kirubakaran, Chellam MD##; Rappaport, Ruth PhDa; Razmpour, Ahmad PhDa; Gruber, William C. MDa; Forrest, Bruce D. MD, MBAb; for the Pan-Asian CAIV-T Pediatric Efficacy Trial Network

Pediatric Infectious Disease Journal: July 2007 - Volume 26 - Issue 7 - pp 619-628
doi: 10.1097/INF.0b013e31806166f8
Original Studies

Background: This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia.

Methods: In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally ≥28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo.

Results: Mean age at enrollment was 23.5 ± 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8–80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9–77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1–92.4%) and any (64.2%; 95% CI: 44.2–77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients.

Conclusions: CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia.

From the *Department of Microbiology and Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong; Departments of †Microbiology and ‡Health, Research Institute for Tropical Medicine, Muntinlupa City, Philippines; §Department of Paediatrics, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; ∥Queen Sirikit National Institute of Child Health, Bangkok, Thailand; ¶Beijing Children's Hospital, Beijing, China; #Department of Pediatrics, College of Medicine, **Department of Pediatrics, College of Public Health, National Taiwan University Hospital, Taipei, Taiwan; ††Department of Paediatrics, National University Hospital, Singapore; ‡‡Laboratory of Virology, Capital Institute of Pediatrics, Beijing, China; §§Department of Paediatrics, Phramongkutklao Hospital, Bangkok, Thailand; ∥∥Department of Paediatrics, Charoenkrung Pracharak Metropolis Hospital, Bangkok, Thailand; ¶¶Department of Paediatrics, Sri Avittam Tirunal Hospital Medical College, Trivandrum, India; ##Department of Child Health and Paediatric Haemato-Oncology, Christian Medical College and Hospital, Vellore, India; aWyeth Vaccines Research, Pearl River, NY, and bWyeth Vaccines Research, Tokyo, Japan.

Accepted for publication March 22, 2007.

Address for correspondence: John S. Tam, PhD, Wyeth Research, 401 N. Middletown Road, Pearl River, NY 10965; E-mail: tamj1@wyeth.com.

© 2007 Lippincott Williams & Wilkins, Inc.