Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
807
0.5 mL, IM
0.5 mL, IM
Unnamed facility
Espoo, Finland
Unnamed facility
Helsinki, Finland
Unnamed facility
Helsinki, Finland
Unnamed facility
Jarvenpaa, Finland
Unnamed facility
Jyväskylä, Finland
Unnamed facility
Kotka, Finland
Unnamed facility
Lahti, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Pori, Finland
Unnamed facility
Tampere, Finland
...and 4 more locations
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
Time frame: 1 Month post-dose 3
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Time frame: Entire study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.