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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00126945
Other study ID # 104702
Secondary ID
Status Completed
Phase Phase 2
First received August 4, 2005
Last updated September 20, 2016
Start date August 2005
Est. completion date October 2005

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 19 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal Vaccine


Locations

Country Name City State
Denmark GSK Investigational Site Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Denmark, 

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