Status:
COMPLETED
Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
Lead Sponsor:
Statens Serum Institut
Conditions:
Active Immunization
Eligibility:
All Genders
28-49 years
Phase:
PHASE3
Brief Summary
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The investigational va...
Eligibility Criteria
Inclusion
- The parents were informed about the trial and have signed the consent form
- The subject is healthy
- The subject has an age of 28 to 49 days at hepatitis B vaccination
- The subject had a birth weight of ≥2500 g
- The subject has received a hepatitis B vaccination at birth
- The parents grant access to the subject's medical records
- The parents are likely to comply with instructions
Exclusion
- The subject suffers from a severe chronic disease
- The subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or Hib vaccines
- The subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including Act-HIB® and hepatitis B vaccines
- The subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections
- The subject has a known congenital or acquired immunodeficiency
- The subject is in treatment with or has been in treatment with a product which is likely to modify the immune response (i.e. immunoglobulin, systemic corticosteroids, blood products, other vaccines)
- The subject is participating in another clinical trial
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
817 Patients enrolled
Trial Details
Trial ID
NCT00655148
Start Date
September 1 2003
End Date
October 1 2006
Last Update
January 21 2013
Active Locations (5)
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1
Centre Bydgoszcz
Bydgoszcz, Poland
2
Centre Krakow
Krakow, Poland
3
Centre Lodz
Lodz, Poland
4
Centre Poznan
Poznan, Poland