Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

Phase 4

Completed

• Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B
• Interventions: Biological: Shan5

• Registration Number: NCT00617812
• Lead Sponsor: Shantha Biotechnics Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Study Start: 2008-03
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-24
• Last Update Posted: 2009-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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• Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shan5	Shan5	-

Primary Outcome Measures

Name	Time	Method
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.	4 months

Secondary Outcome Measures

Name	Time	Method
Solicited and unsolicited local and systemic adverse events following vaccination	4 months

Trial Locations

Locations (4)

Institute of Child Health; 🇮🇳 Kolkata, West Bengal, India

Deccan College of Medical Sciences; 🇮🇳 Hyderabaad, Andhra Pradesh, India

Ankur Institute of Child Health; 🇮🇳 Ahmedabad, Gujrat, India

JSS Medical College; 🇮🇳 Mysore, Karnataka, India