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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196950
• Other study ID #: 134612/003
• Secondary ID: 1022521022531022
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 6, 2016
• Start date: September 2003
• Est. completion date: October 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal (vaccine)

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gosselies

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

References & 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. Erratum in: Vaccine. 2009 Dec 9;27(52):7467. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.			No
Secondary	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			No

External Links

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