NCT00674908CompletedPhase 4
A Single Blind, Multicentric, Comparative, Vaccine Interchangeability Trial of Shan 5 (Liquid) and Easy Five (Liquid) [Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib Pentavalent Combination Vaccines] in Indian Infants.
Shantha Biotechnics Limited3 sites in 1 country144 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Shantha Biotechnics Limited
- Enrollment
- 144
- Locations
- 3
- Primary Endpoint
- Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen.
Study Overview
Brief Summary
The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Weeks to 8 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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 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 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- •Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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
Arms & Interventions
Easy 5
Active Comparator
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
Intervention: Easy Five (Biological)
Shan 5
Experimental
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Intervention: Shan 5 (Biological)
Outcomes
Primary Outcomes
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen.
Time Frame: 4 months
Secondary Outcomes
- Solicited and unsolicited local and systemic adverse events following vaccination(4 months)
Investigators
Study Sites (3)
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