CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 310 enrolled
Drug / intervention
DTaP-IPV-HB-PRP~T vaccine +2 morebiological
Likely dose
0.5 mL intramuscular injection per vaccineAI-extracted
Key inclusion· 4
  • ✓Two-month-old infants of either gender
  • ✓Born at full term (≥37 weeks) with birth weight ≥2.5 kg
  • ✓Informed consent signed by parent(s) or legal representative(s)
  • ✓Able to attend all scheduled visits and comply with trial procedures
Key exclusion· 12
  • ✕Congenital or acquired immunodeficiency or immunosuppressive therapy (including long-term systemic corticosteroids)
  • ✕Systemic hypersensitivity to vaccine components or history of life-threatening reaction to similar vaccine
  • ✕Chronic illness that could interfere with trial conduct or completion
  • ✕Blood or blood-derived products received since birth

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00315055
NCT00315055Phase 3Completed
CompareCT.gov

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

Sanofi Pasteur, a Sanofi Company·interventional·Posted Apr 17, 2006·Updated Sep 12, 2014

In Brief

A Phase 3 clinical trial evaluating DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, and 1 other intervention for Hepatitis B and 3 related conditions. Completed, enrolled 310 participants across 1 site.

Detailed Summary

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity * To assess pre- and post-primary series * To assess pre- and post-booster series.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Polio, Diphtheria, Pertussis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.2 years ago

Interventions

DTaP-IPV-HB-PRP~T vaccinebiological

0.5 mL, Intramuscular (IM)

DTaP-IPV//PRP~T combinedbiological

0.5 mL, IM

Hepatitis B vaccinebiological

0.5 mL, IM