Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study

Human Vaccines & Immunotherapeutics
Dang Duc AnhH H Han

Abstract

The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years.

References

Dec 26, 2001·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·C T Le
Apr 23, 2003·Vaccine·Tom JeffersonCarlo DiPietrantonj
Sep 28, 2006·Tropical Medicine & International Health : TM & IH·Voranush ChongsrisawatYong Poovorawan
Mar 29, 2014·BioMed Research International·Giovanni GabuttiGiorgio Zoppi

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NCT01577732

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Statistical Analysis Systems ( SAS )

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