Title |
Reactogenicity and tolerability of a non-adjuvanted 11-valent diphtheria-tetanus toxoid pneumococcal conjugate vaccine in Filipino children
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Published in |
Vaccine, October 2008
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DOI | 10.1016/j.vaccine.2008.10.026 |
Pubmed ID | |
Authors |
Juanita Ugpo, Marilla Lucero, Gail Williams, Marites Lechago, Leilani Nillos, Veronica Tallo, Hanna Nohynek, Arivac Consortium |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 31 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 10 | 32% |
Student > Master | 8 | 26% |
Student > Bachelor | 3 | 10% |
Student > Ph. D. Student | 3 | 10% |
Student > Doctoral Student | 1 | 3% |
Other | 0 | 0% |
Unknown | 6 | 19% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 11 | 35% |
Nursing and Health Professions | 4 | 13% |
Agricultural and Biological Sciences | 3 | 10% |
Biochemistry, Genetics and Molecular Biology | 2 | 6% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 3% |
Other | 2 | 6% |
Unknown | 8 | 26% |