Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
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ClinicalTrials.gov Identifier: NCT00196950 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 7, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infections, Meningococcal | Biological: Meningococcal (vaccine) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Assess the Safety, Reactogenicity, Immunogenicity & Long-term Persistence of One Intramuscular Dose of GSK Biologicals' MenACWY Conjugate Vaccine vs One Subcutaneous Dose of Mencevax™ ACWY in Healthy Adults Aged 18-25 Yrs |
Study Start Date : | September 2003 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | October 2003 |
- The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.
- Sol (d 0-7, local&general), unsol (d 0-30) symptoms. SAEs. Routine blood & urine examination before, 2&7 d post vacc. % SBA-MenA C W Y responders 1m post vacc. Antibodies to MenA C W Y before, 1, 12, 24&36m post vacc & tetanus before, 1m post vacc

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Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- Healthy male or female between, and including, 18 and 25 years of age at the time of vaccination.
- Written informed consent obtained.
- Subject with previously completed routine childhood vaccinations to the best of his/her knowledge.
- Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception.
Exclusion criteria:
- Previous vaccination against OR history of OR exposure within previous 12 months to, meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a tetanus vaccine within 6 months before study vaccination.
- 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.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- History of chronic alcohol consumption and/or drug abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196950
Belgium | |
GSK Investigational Site | |
Gosselies, Belgium, 6041 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 134612/003 are summarised with studies 102252, 102253, and 102254 on the GSK Clinical Study Register.

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00196950 History of Changes |
Other Study ID Numbers: |
134612/003 102252 ( Other Identifier: GSK ) 102253 ( Other Identifier: GSK ) 102254 ( Other Identifier: GSK ) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 7, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Additional relevant MeSH terms:
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Vaccines Immunologic Factors Physiological Effects of Drugs |