Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

Phase 4

Completed

• Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B
• Interventions: Biological: Shan 5; Biological: Easy Five

• Registration Number: NCT00674908
• Lead Sponsor: Shantha Biotechnics Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Primary Completion: 2009-03
• 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: 144

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• Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shan 5	Shan 5	Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Easy 5	Easy Five	Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Smt NHL Municipal Medical College and LG Hospital; 🇮🇳 Ahmedabad, Gujrat, India

Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, Karnataka, India

Deenanath Mangeshkar Hospital; 🇮🇳 Pune, Maharashtra, India