Last updated: 11/04/2018 04:05:15
study to evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT and Hib-MenC-TT or Meningitec™ in healthy toddlers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate the persistence and immune memory induced by a primary vaccination course with GSK Biologicals’ MenC-TT (1 formulation) & GSK Biologicals’ Hib-MenC-TT (2 formulations) or Meningitec™ in healthy toddlers aged 12-15 months primed in study 711202/001
Trial description: The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals’ MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals’ Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: MenC-TT
Biological/vaccine: Hib-MenC-TT
Enrollment:
500
Observational study model:
Not applicable
Primary completion date:
2003-31-07
Time perspective:
Not applicable
Clinical publications:
Schmitt et al, Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine (2007) Clin Vaccine Immunol, 14 (4): 426–434.
Schmitt HJ et al. (2007) Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine. Clin Vaccine Immunol. 14(4):426–434.
Medical condition
Infections, Meningococcal
Product
Meningococcal Vaccine
Collaborators
Not applicable
Study date(s)
January 2003 to July 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12 - 15 months
Accepts healthy volunteers
Yes
- Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment
- Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment
Exclusion criteria:
- Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
- 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, of allergic disease/reactions likely to be exacerbated by any component of the vaccines
Trial location(s)
No location data available.
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
2003-31-07
Actual study completion date
2003-31-07
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website