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Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

Information source: Shantha Biotechnics Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Intervention: Shan 5 (Biological); Easy Five (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Shantha Biotechnics Limited

Official(s) and/or principal investigator(s):
Raman Rao, MD, Study Director, Affiliation: Shantha Biotechnics Limited

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen.

Secondary outcome: Solicited and unsolicited local and systemic adverse events following vaccination

Eligibility

Minimum age: 6 Weeks. Maximum age: 8 Weeks. Gender(s): Both.

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

Locations and Contacts

Smt NHL Municipal Medical College and LG Hospital, Ahmedabad, Gujrat 380006, India

Kempegowda Institute of Medical Sciences, Bangalore, Karnataka 560070, India

Deenanath Mangeshkar Hospital, Pune, Maharashtra 411004, India

Additional Information

Starting date: March 2008
Last updated: June 24, 2009

Page last updated: August 20, 2015

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