Status:
COMPLETED
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
Lead Sponsor:
Shantha Biotechnics Limited
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-8 years
Phase:
PHASE4
Brief Summary
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 heal...
Eligibility Criteria
Inclusion
- Healthy children in the age group six to eight weeks
- Born after a normal gestational period (36 - 42 weeks)
- Mother's HBsAg assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents willing to fill the Diary Card
Exclusion
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
- Previous vaccination or evidence of infection with DTP.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
- Major congenital or hereditary immunodeficiency.
- Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
- Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
- Parent/s or guardian of subject unable to maintain diary card
- Simultaneous participation in any other clinical study
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00617812
Start Date
March 1 2008
End Date
May 1 2009
Last Update
June 25 2009
Active Locations (4)
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1
Deccan College of Medical Sciences
Hyderabaad, Andhra Pradesh, India, 500058
2
Ankur Institute of Child Health
Ahmedabad, Gujarat, India, 380009
3
JSS Medical College
Mysore, Karnataka, India, 570015
4
Institute of Child Health
Kolkata, West Bengal, India, 700017