Last updated: 11/03/2018 00:24:11
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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Any grade 3 solicited symptoms (d 0 – 3)
Timeframe: Not applicable
Secondary outcomes:
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
Timeframe: Not applicable
Interventions:
Biological/vaccine: Haemophilus influenzae type b- and meningococcal (vaccine)
Enrollment:
297
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Carmona A et al. (2010) Reactogenicity and immunogenicity of combined Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine booster dose coadministered with measles, mumps, and rubella vaccine. Pediatr Infect Dis J. 29(3):269-271.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB811936
Collaborators
Not applicable
Study date(s)
March 2005 to September 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
13 - 14 months
Accepts healthy volunteers
Yes
- 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.
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Sant Adriá de Beyós, Barcelona, Spain, 08930
Status
Study Complete
Location
GSK Investigational Site
Mollet del Valles/Barcelona, Spain, 08100
Status
Study Complete
Location
GSK Investigational Site
Sant Eugenia de Berga, Barcelona, Spain, 08519
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-23-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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