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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00227422
First received: September 26, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Infections, Meningococcal
Biological: Mencevax ACWY
Phase 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Immuno : the same immuno evaluation performed 1 month after vaccination will also be performed before vaccination; also vaccine response at Post-dose 1.
  • Safety : Solicited symptoms during day 0-3, unsol. symptoms during day 0-30 & SAEs during entire study.

Estimated Enrollment: 324
Study Start Date: June 2005
Study Completion Date: November 2005
Detailed 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
  Eligibility

Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227422

Locations
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 102394
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00227422     History of Changes
Other Study ID Numbers: 102394 
Study First Received: September 26, 2005
Last Updated: September 20, 2016
Health Authority: Lebanon: Lebanese Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis serogroups A & C diseases
Hib diseases

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 26, 2016