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

NCT00196950 | Completed Phase 2

• 4 other identifiers: 134612/003102252102253102254
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Meningococcal

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Meningococcal (vaccine) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Gosselies, 6041, Belgium

Location

Related Publications (1)

• 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.

  PMID: 18834910 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2003
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)