Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

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.

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Type B
• Intervention / Treatment: Biological: Shan 5; Biological: Easy Five

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Gujrat
    • Ahmedabad, Gujrat, India, 380006
      • Smt NHL Municipal Medical College and LG Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560070
      • Kempegowda Institute of Medical Sciences
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shan 5; Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine	Biological: Shan 5; Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
Active Comparator: Easy 5; Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine	Biological: Easy Five; Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Solicited and unsolicited local and systemic adverse events following vaccination	4 months

Collaborators and Investigators

• Sponsor: Shantha Biotechnics Limited
• Investigators: Study Director: Raman Rao, MD, Shantha Biotechnics Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 8, 2008

Study Record Updates

• Last Update Posted (Estimate): June 25, 2009
• Last Update Submitted That Met QC Criteria: June 24, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Vaccine; Prevention; Hepatitis B; Pertussis; Diphtheria; Tetanus; Haemophilus influenzae type b; Vaccine interchangeability; Single vs mixed sequence; Healthy infants
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Neurologic Manifestations; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Hepatitis B; Whooping Cough; Hepatitis; Hepatitis A; Tetanus; Diphtheria; Tetany
• Other Study ID Numbers: SBL/DTPwHB-Hib/INT/2007/0200