Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.

Condition or disease	Intervention/treatment	Phase
Infections, Meningococcal	Biological: Meningococcal (vaccine)	Phase 2

Detailed Description:

Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. The study consists of a vaccination phase during which subjects receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine) and 3 years of follow-up. There are in total 7 visits to the doctor: before and 2, 7 and 30 days after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination (follow-up phase). 7 blood samples are taken: one at each visit.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 25 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
GSK Investigational Site
Gosselies, Belgium, 6041

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. 

Study Data/Documents: Dataset Specification 

Identifier: 134612/003
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 134612/003
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 134612/003
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.

Informed Consent Form 

Identifier: 134612/003
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 134612/003
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 134612/003
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

Ostergaard L, Lebacq E, Poolman J, Maechler G, Boutriau D. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. Vaccine. 2009 Jan 1;27(1):161-8. doi: 10.1016/j.vaccine.2008.08.075. Epub 2008 Oct 1. Erratum in: Vaccine. 2009 Dec 9;27(52):7467.

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
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