Status:
COMPLETED
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Acellular Pertussis
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: * one group of subjects will receive diphtheria, tetanus, acellular...
Detailed Description
DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The durat...
Eligibility Criteria
Inclusion
- A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
- Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.
Exclusion
- Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
- Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00316147
Start Date
December 1 2005
End Date
August 1 2006
Last Update
September 28 2016
Active Locations (4)
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1
GSK Investigational Site
Bangalore, India, 560034
2
GSK Investigational Site
Baroda, India, 390 001
3
GSK Investigational Site
Goa, India, 403202
4
GSK Investigational Site
New Delhi, India, 110002