A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,000
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
School of Public Health, Post Graduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, India
RECRUITINGSolicited and unsolicited local and systemic adverse events following vaccination
Time frame: 4 Months
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine
Time frame: 12 Months
Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots
Time frame: 4 months
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