Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine
Information source: Shantha Biotechnics Limited
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B
Intervention: Shan 5 (Biological); Easy Five (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Shantha Biotechnics Limited Official(s) and/or principal investigator(s): Raman Rao, MD, Study Director, Affiliation: Shantha Biotechnics Limited
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen.
Secondary outcome: Solicited and unsolicited local and systemic adverse events following vaccination
Eligibility
Minimum age: 6 Weeks.
Maximum age: 8 Weeks.
Gender(s): Both.
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 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
Locations and Contacts
Smt NHL Municipal Medical College and LG Hospital, Ahmedabad, Gujrat 380006, India
Kempegowda Institute of Medical Sciences, Bangalore, Karnataka 560070, India
Deenanath Mangeshkar Hospital, Pune, Maharashtra 411004, India
Additional Information
Starting date: March 2008
Last updated: June 24, 2009
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