The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age
Pasteur Institute
Ho Chi Minh City, Vietnam
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time frame: at 5 months (equivalent to 1 month after the third vaccination)
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time frame: at 14 months (equivalent to 12 months after the first vaccination
Safety: Adverse and Serious Adverse Events
Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection
Time frame: From Day 1 up to 30 days after the third vaccination
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