Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs

A Primary Vaccination Study to Assess the Immunogenicity, Safety & Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals' Meningococcal Conjugate Vaccine (MenACWY) vs 1 Dose of MENCEVAX™ ACWY in Healthy Subjects Aged 15-19 Years

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126945

Enrollment

125

Registered

2005-08-05

Start date

2005-08-31

Completion date

2005-10-31

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Meningococcal

Keywords

Meningococcal serogroups A, C, W-135, Y disease

Brief summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

Detailed description

The study is open. However, the 4 different formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner. Mencevax™ ACWY vaccine will serve as active control. Subjects will receive one vaccine dose only (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.

Interventions

BIOLOGICALMeningococcal Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 19 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination. * Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge. * Female subjects should be of non-childbearing potential.

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.

Design outcomes

Primary

Measure	Time frame
Percentage of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in serum bactericidal antibody [SBA] titre from pre to post vaccination) at 1 month after the first vaccine dose	—

Secondary

Measure	Time frame
Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster	—
Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026