The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with Infanrix™ hexa. The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
709
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kotka, Finland
GSK Investigational Site
Lahti, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Pori, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Turku, Finland
...and 6 more locations
SBA-MenC titre
Time frame: One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration
Time frame: One month after the second dose of the Primary Vaccination Phase
SBA-MenC titres
Time frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PRP concentrations
Time frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PSC concentrations
Time frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.
Anti-HBs concentrations
Time frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Occurrence of local solicited adverse events.
Time frame: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of solicited general adverse events
Time frame: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of unsolicited non-serious adverse events
Time frame: Within 30 days after each vaccination
Occurrence of any serious adverse events
Time frame: Throughout the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.