Clinical Trial: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Brief Summary: This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
Detailed Summary: This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.
Sponsor: GlaxoSmithKline
Current Primary Outcome: Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with a titer equal to or above the cut-off value [ Time Frame: One month post-dose 3 (Month 5) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Immunogenicity with respect to components of the investigational vaccine in terms of number of subject with titers equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Immunogenicity with respect to components of the co-administered vaccines in terms of number of subjects with concentrations equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Number of subjects with solicited local and general symptoms [ Time Frame: Within 8 days (Day0 to Day7) after each vaccine dose ]
- Number of subjects with unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to 30) after each vaccine dose ]
- Number of subjects with serious adverse events [ Time Frame: Throughout the study period (Month 0 to Month 19) ]
- Number of subjects with new onset of chronic illnesses [ Time Frame: Throughout the study period (Month 0 to Month 19) ]
- Immunogenicity with respect to components of the investigational vaccine in terms of antibody titers [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with vaccine response [ Time Frame: At Month 14 ]
- Immunogenicity with respect to components of the co-administered vaccines in terms of antibody concentrations [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
Original Secondary Outcome:
- Immunogenicity with respect to components of the investigational vaccine in terms of number of subject with titers equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Immunogenicity with respect to components of the co-administered vaccines in terms of number of subjects with concentrations equal to or above cut-off values [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Number of subjects with solicited local and general symptoms [ Time Frame: Within 8 days (Day0 to Day7) after each vaccine dose ]
- Number of subjects with unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to 30) after each vaccine dose ]
- Number of subjects with serious adverse events [ Time Frame: Throughout the study period (Month 0 to Month 19) ]
- Number of subjects with new onset of chronic diseases [ Time Frame: Throughout the study period (Month 0 to Month 19) ]
- Immunogenicity with respect to components of the investigational vaccine in terms of antibody titers [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
- Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with vaccine response [ Time Frame: At Month 14 ]
- Immunogenicity with respect to components of the co-administered vaccines in terms of antibody concentrations [ Time Frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14) ]
Information By: GlaxoSmithKline
Dates:
Date Received: April 14, 2011
Date Started: January 2012
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017