Last updated: 11/03/2018 20:32:02
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results
A phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of three different formulations of GlaxoSmithKline (GSK) Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MenC-CRM197 conjugate vaccine or MencevaxACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of three different formulations of GlaxoSmithKline (GSK) Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MenC-CRM197 conjugate vaccine or MencevaxACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old.
Trial description: A phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of three different formulations of GlaxoSmithKline (GSK) Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MenC-CRM197 conjugate vaccine or MencevaxACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Meningococcal Vaccines
Product
GSK134612A
Collaborators
Not applicable
Study date(s)
January 2004 to June 2004
Type
Not applicable
Phase
1/2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2004-07-06
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
Not applicable
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