The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
160
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Deccan College of Medical Sciences
Hyderabaad, Andhra Pradesh, India
Ankur Institute of Child Health
Ahmedabad, Gujarat, India
JSS Medical College
Mysore, Karnataka, India
Institute of Child Health
Kolkata, West Bengal, India
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.
Time frame: 4 months
Solicited and unsolicited local and systemic adverse events following vaccination
Time frame: 4 months
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