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 enrollmentMarch 2008

ConditionsDiphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diphtheria
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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shantha Biotechnics Limited

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 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

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