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
Study complete
Study complete
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:
Enrollment:
468
Primary completion date:
Not applicable
Observational study model:
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)
Showing 1 - 6 of 16 Results
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
Study complete
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.
Additional information about the trial
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