Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine

NCT ID: NCT00877357

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-02-28

Brief Summary

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Shan 5 Lot No 1

Group Type: EXPERIMENTAL

Shan 5

Intervention Type: BIOLOGICAL

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Shan 5 Lot No 2

Group Type: EXPERIMENTAL

Shan 5

Intervention Type: BIOLOGICAL

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Shan 5 Lot No 3

Group Type: EXPERIMENTAL

Shan 5

Intervention Type: BIOLOGICAL

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Interventions

Shan 5

Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine

Intervention Type: BIOLOGICAL

Eligibility 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 (hepatitis B surface antigen) assured negative.
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.

Exclusion Criteria

• Administration of immunoglobulin or any blood products since birth.
• Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination 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 born to mothers known to be HIV positive.
• 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 40.40C, 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Shantha Biotechnics Limited

Principal Investigators

Raman Rao, MD

Role: STUDY_DIRECTOR

Shantha Biotechnics Limited

Locations

School of Public Health, Post Graduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, India

Site Status: RECRUITING

Countries

India

Central Contacts

Mandeep S Dhingra, MD

Role: CONTACT

drmandeep@shanthabiotech.co.in

+91-40-66301000 ext. 1801

Facility Contacts

Madhu Gupta, MD

Role: primary

madhugupta21@gmail.com

+91-172-2755223

Other Identifiers

SBL/DTPwHBHib/WHOCON/2008/0100

Identifier Type: -

Identifier Source: org_study_id