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

Phase 4

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

• Registration Number: NCT00877357
• Lead Sponsor: Shantha Biotechnics Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-04
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Last Update Submitted: 2009-05-05
• Last Update Posted: 2009-05-06
• Primary Completion: 2012-12
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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• Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shan 5 Lot No 1	Shan 5	-
Shan 5 Lot No 2	Shan 5	-
Shan 5 Lot No 3	Shan 5	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine	12 Months
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

Trial Locations

Locations (1)

School of Public Health, Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, UT, India