Last updated: 11/06/2018 23:56:29
Study of a booster dose of Hib-MenC conjugate vaccine vs Infanrix Hexa when given to 14 month old subjects
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate immunogenicity,safety & reactogenicity of a booster dose of Hib-MenC conjugate vaccine when given to healthy subjects aged 13-14 months who were primed with 3 doses of Hib-MenC vs a booster dose of Infanrix hexa given to subjects primed with 3 doses of Infanrix hexa and Meningitec
Trial description: The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
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: Haemophilus influenzae type b- and meningococcal (vaccine)
Enrollment:
468
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tejedor JC et al. (2008) Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age. Pediatr Infect Dis J. 27(7): 579–588.
Medical condition
Neisseria Meningitidis, Haemophilus influenzae type b
Product
SB811936
Collaborators
Not applicable
Study date(s)
November 2004 to March 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
- Having participated in the primary vaccination study 217744/097.
- Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male or female between, and including, 13 and 14 months of age
- Having participated in the primary vaccination study 217744/097.
Exclusion criteria:
- Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- 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
Trial location(s)
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
2005-17-03
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.
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