Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Brief summary
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.
Detailed description
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
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Months to 14 Months
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any grade 3 solicited symptoms (d 0 - 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed