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OpenTrials
Completed

NCT Number: NCT00196950

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Gosselies, 6041, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meningococcal (vaccine)

Biological

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Sep 20, 2005
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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