Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

Hepatitis B Clinical Trial

Official title:

An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617812
• Other study ID #: SBL/DTPwHB-Hib/PMS/2007/0100
• 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

Related Conditions & MeSH terms

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

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