Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00674908
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B Biological: Shan 5 Biological: Easy Five Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009


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




Primary Outcome Measures :
  1. Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Solicited and unsolicited local and systemic adverse events following vaccination [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674908


Locations
Layout table for location information
India
Smt NHL Municipal Medical College and LG Hospital
Ahmedabad, Gujrat, India, 380006
Kempegowda Institute of Medical Sciences
Bangalore, Karnataka, India, 560070
Deenanath Mangeshkar Hospital
Pune, Maharashtra, India, 411004
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
Layout table for investigator information
Study Director: Raman Rao, MD Shantha Biotechnics Limited

Layout table for additonal information
Responsible Party: Head Clinical Research and Medical Affairs, Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00674908     History of Changes
Other Study ID Numbers: SBL/DTPwHB-Hib/INT/2007/0200
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009
Keywords provided by Shantha Biotechnics Limited:
Vaccine
Prevention
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus influenzae type b
Vaccine interchangeability
Single vs mixed sequence
Healthy infants
Additional relevant MeSH terms:
Layout table for MeSH terms
Whooping Cough
Tetanus
Diphtheria
Hepatitis A
Hepatitis B
Hepatitis
Tetany
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases