Status:
COMPLETED
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
Lead Sponsor:
GlaxoSmithKline
Conditions:
Poliomyelitis
Tetanus
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE3
Brief Summary
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.
Eligibility Criteria
Inclusion
- Healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 \& 42 weeks).
- Written informed consent obtained from the parent/guardian of the subject.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
- Administration of immunosuppressants or other immune-modifying drugs from birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.
Key Trial Info
Start Date :
September 30 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2004
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00352963
Start Date
September 30 2003
End Date
July 16 2004
Last Update
January 6 2020
Active Locations (22)
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1
GSK Investigational Site
Alcorcón, Spain, 28922
2
GSK Investigational Site
Almeira, Spain, 4009
3
GSK Investigational Site
Badalona, Spain, 08916
4
GSK Investigational Site
Barcelona, Spain, 08025