Clinical trial NCT00674908: Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type B
Keywords: Vaccine
Prevention
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus influenzae type b
Vaccine interchangeability
Single vs mixed sequence
Healthy infants
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 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* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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

Primary outcomes:
measure: Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccines in a single and mixed sequence regimen.
timeFrame: 4 months
Secondary outcomes:
measure: Solicited and unsolicited local and systemic adverse events following vaccination
timeFrame: 4 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Smt NHL Municipal Medical College and LG Hospital
state: Gujrat
city: Bangalore
country: India
facility: Kempegowda Institute of Medical Sciences
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
state: Maharashtra
Study officials:
affiliation: Shantha Biotechnics Limited
name: Raman Rao, MD
role: STUDY_DIRECTOR
References: