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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00617812
Other study ID # SBL/DTPwHB-Hib/PMS/2007/0100
Secondary ID
Status Completed
Phase Phase 4
First received February 6, 2008
Last updated June 24, 2009
Start date March 2008
Est. completion date May 2009

Study information

Verified date June 2009
Source Shantha Biotechnics Limited
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Interventional

Clinical Trial 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 healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 8 Weeks
Eligibility 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.

- 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- Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Shan5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Locations

Country Name City State
India Ankur Institute of Child Health Ahmedabad Gujrat
India Deccan College of Medical Sciences Hyderabaad Andhra Pradesh
India Institute of Child Health Kolkata West Bengal
India JSS Medical College Mysore Karnataka

Sponsors (1)

Lead Sponsor Collaborator
Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. 4 months No
Secondary Solicited and unsolicited local and systemic adverse events following vaccination 4 months Yes
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