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

Hepatitis B Clinical Trial

Official title:

Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00877357
• Other study ID #: SBL/DTPwHBHib/WHOCON/2008/0100
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: May 5, 2009
• Start date: January 2009
• Est. completion date: February 2013

Study information

• Verified date: April 2009
• Source: Shantha Biotechnics Limited
• Contact: Mandeep S Dhingra, MD
• Phone: +91-40-66301000
• Email: drmandeep[@]shanthabiotech.co.in
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• 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 (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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
India	School of Public Health, Post Graduate Institute of Medical Education and Research	Chandigarh	UT

Sponsors (1)

Lead Sponsor	Collaborator
Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited and unsolicited local and systemic adverse events following vaccination		4 Months	Yes
Secondary	Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine		12 Months	No
Secondary	Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots		4 months	Yes