Clinical trial NCT00617812: Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
Official title: An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) 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
Healthy infants
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.


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.
* 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* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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 vaccine.
timeFrame: 4 months
Secondary outcomes:
measure: Solicited and unsolicited local and systemic adverse events following vaccination
timeFrame: 4 months
Other outcomes:
Locations:
city: Hyderabaad
country: India
facility: Deccan College of Medical Sciences
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Ankur Institute of Child Health
state: Gujrat
city: Mysore
country: India
facility: JSS Medical College
state: Karnataka
city: Kolkata
country: India
facility: Institute of Child Health
state: West Bengal
Study officials:
affiliation: Shantha Biotechnics Limited, Hyderabad, India
name: Raman Rao, MD
role: STUDY_DIRECTOR
References: