DTaP-IPV vero vaccine
BiologicalDTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Completed
NCT Number: NCT00655148
Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
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 vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
28 day–49 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Centre Bydgoszcz, Bydgoszcz, Poland
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
DTaP-IPV mkc vaccine
BiologicalDTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Primary outcomes
-
Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types
Time frame: One month after the third vaccination
Sponsors and collaborators
Lead sponsor
Statens Serum Institut
Other
Registry information
Official study title
Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age
Important dates
- Study start
- 2003
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Apr 9, 2008
- Registry last updated
- Jan 21, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.