Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children

Ugpo, Juanita, Lucero, Marilla, Williams, Gail, Lechago, Marites, Nillos, Leilani, Tallo, Veronica, Nohynek, Hanna and Arivac Consortium (2009) Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children. Vaccine, 27 20: 2723-2729. doi:10.1016/j.vaccine.2008.10.026


Author Ugpo, Juanita
Lucero, Marilla
Williams, Gail
Lechago, Marites
Nillos, Leilani
Tallo, Veronica
Nohynek, Hanna
Arivac Consortium
Title Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children
Journal name Vaccine   Check publisher's open access policy
ISSN 0264-410X
Publication date 2009-05-05
Year available 2008
Sub-type Article (original research)
DOI 10.1016/j.vaccine.2008.10.026
Open Access Status
Volume 27
Issue 20
Start page 2723
End page 2729
Total pages 7
Editor Dr. R E Spier
Place of publication United Kingdom
Publisher Elsevier Ltd
Language eng
Subject C1
070706 Veterinary Medicine
070705 Veterinary Immunology
Abstract In a phase three randomized, double-blind, saline-placebo controlled study conducted in Bohol, Philippines, we assessed the reactogenicity of an 11-valent PCV (11PCV) when given simultaneously with EPI vaccines at 6, 10 and 14 weeks of age in a subset of 252 and 126 children who were followed-up by passive and active surveillance, respectively. In passive surveillance (parents’ observation), redness was observed in 14.4% vs. 11.8%, swelling in 8% vs. 3.9%, induration in 13.6% vs. 8.6%, and pain in 54.4% vs. 47.2% of 11PCV and placebo infants, respectively, after the first dose of the vaccine. Redness at injection site was significantly more common with 11PCV than placebo infants after the third dose (13.6% vs. 3.2%, p = 0.005). Crying (53.6% vs. 48%), irritability (48% vs. 46.4%), and fever (22.4% vs. 19.6%) were commonly observed in 11PCV and placebo infants, respectively, after the first dose. Loss of appetite was significantly more common among 11PCV (12%) than placebo (4.7%) infants but only after the first dose of the vaccine (P = 0.04). The number of reactions decreased in both groups with subsequent doses. The non-adjuvanted 11PCV vaccine was found to be well-tolerated among Filipino infants.
Keyword Reactogenicity
Pneumococcal conjugate vaccine
Adverse events
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Available online 31 October 2008.

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2009 Higher Education Research Data Collection
School of Public Health Publications
 
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Created: Mon, 15 Jun 2009, 21:39:43 EST by Cameron Harris on behalf of Office of Sponsored Research