Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

Hepatitis B Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674908
• Other study ID #: SBL/DTPwHB-Hib/INT/2007/0200
• Status: Completed
• Phase: Phase 4
• First received: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 2009
• Est. primary completion date: March 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
• Easy Five
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine

Locations

Country	Name	City	State
India	Smt NHL Municipal Medical College and LG Hospital	Ahmedabad	Gujrat
India	Kempegowda Institute of Medical Sciences	Bangalore	Karnataka
India	Deenanath Mangeshkar Hospital	Pune	Maharashtra

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 vaccines in a single and mixed sequence regimen.		4 months	No
Secondary	Solicited and unsolicited local and systemic adverse events following vaccination		4 months	Yes