Brief Title
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
Official Title
Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants
Brief Summary
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Solicited and unsolicited local and systemic adverse events following vaccination
Secondary Outcome
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine
Condition
Diphtheria
Intervention
Shan 5
Study Arms / Comparison Groups
Shan 5 Lot No 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3000
Start Date
January 2009
Completion Date
February 2013
Primary Completion Date
December 2012
Eligibility Criteria
Inclusion Criteria: - Healthy children in the age group six to eight weeks - Born after a normal gestational period (36 - 42 weeks) - Mother's HBsAg (hepatitis B surface antigen) assured negative. - Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. Exclusion Criteria: - Administration of immunoglobulin or any blood products since birth. - Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination 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 or Hib. - 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 born to mothers known to be HIV positive. - 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 40.40C, 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
Gender
All
Ages
6 Weeks - 8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Raman Rao, MD, +91-40-66301000, [email protected]
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT00877357
Organization ID
SBL/DTPwHBHib/WHOCON/2008/0100
Study Sponsor
Shantha Biotechnics Limited
Study Sponsor
Raman Rao, MD, Study Director, Shantha Biotechnics Limited
Verification Date
April 2009