Skip Navigation LinksHome > July 2007 - Volume 26 - Issue 7 > Efficacy and Safety of a Live Attenuated, Cold-Adapted Influ...
Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e31806166f8
Original Studies

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

Collapse Box

Abstract

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.

© 2007 Lippincott Williams & Wilkins, Inc.

Login

Article Tools

Share

Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.