Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs

Infections, Meningococcal Clinical Trial

Official title:

A Phase IV, Partially Double-blind Study to Demonstrate Non-inferiority of GSK Biologicals' Mencevax™ ACWY (New Process) Versus Mencevax™ ACWY (Current Process) When Administered as a Single Dose to Subjects Aged 2-30 Yrs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227422
• Other study ID #: 102394
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2005
• Last updated: September 20, 2016
• Start date: June 2005
• Est. completion date: November 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Lebanese Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

Description:

"Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 30 Years

Eligibility

Inclusion criteria:

• Healthy male or female between 2 and 30 years of age at the time of vaccination.

• If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.

• Vaccination with a meningococcal vaccine within the last five years.

• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.

• History of or known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Mencevax ACWY

Locations

Country	Name	City	State
Lebanon	GSK Investigational Site	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 month after vaccination, measurement of serum bactericidal titers against meningococcal serogroups A, C, W135 and Y (SBA-MenA; SBA-MenC; SBA-MenW135 and SBA-MenY)
Secondary	Immuno : the same immuno evaluation performed 1 month after vaccination will also be performed before vaccination; also vaccine response at Post-dose 1.
Secondary	Safety : Solicited symptoms during day 0-3, unsol. symptoms during day 0-30 & SAEs during entire study.

External Links

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