Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

NCT ID: NCT00617812

Last Updated: 2009-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-05-31

Brief 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.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Shan5

Group Type: EXPERIMENTAL

Shan5

Intervention Type: BIOLOGICAL

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

Interventions

Shan5

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

Intervention Type: BIOLOGICAL

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.
• 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Shantha Biotechnics Limited

Principal Investigators

Raman Rao, MD

Role: STUDY_DIRECTOR

Shantha Biotechnics Limited, Hyderabad, India

Locations

Deccan College of Medical Sciences

Hyderabaad, Andhra Pradesh, India

Ankur Institute of Child Health

Ahmedabad, Gujarat, India

JSS Medical College

Mysore, Karnataka, India

Institute of Child Health

Kolkata, West Bengal, India

Countries

India

Other Identifiers

SBL/DTPwHB-Hib/PMS/2007/0100

Identifier Type: -

Identifier Source: org_study_id