Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.
Condition or disease
Haemophilus Influenzae Type bNeisseria Meningitidis
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain
Study to Evaluate the Safety, Reactogenicity & Immunogenicity of a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™, vs Hib-MenC or Priorix™ Only, in Toddlers (13-14 m) Primed With 3 Doses of Hib (as Part of a DTPa -Containing Vaccine) & MenC-CRM197 Conjugate Vaccines.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
13 Months to 14 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male or female between, and including, 13 and 14 months of age.
Previously completed 3-dose primary vaccination with a MenC-CRM197 vaccine, and Hib (given as part of a combined DTPa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period.
Previous vaccination against OR history of H. influenzae type b (Hib) and/or meningococcal serogroup C disease and/or measles, mumps or rubella OR known exposure to measles, mumps or rubella within 30 days prior to the start of the present study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of any neurologic disorders or seizures.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine