ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
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.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00227422
  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
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Infections
Meningococcal Infections
Biological: Mencevax ACWY
Phase IV

MedlinePlus related topics:   Diphtheria    Hepatitis    Hepatitis B    Tetanus    Whooping Cough   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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
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

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

Locations
Lebanon
      Beirut, Lebanon

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     Clinical Trials     GlaxoSmithKline    
  More Information

Study ID Numbers:   102394
First Received:   September 26, 2005
Last Updated:   November 24, 2006
ClinicalTrials.gov Identifier:   NCT00227422
Health Authority:   Lebanon: Lebanese Ministry of Health

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

Study placed in the following topic categories:
Haemophilus Infections
Bacterial Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Cough
Neisseria meningitidis
Diphtheria
Tetanus
Whooping cough
Meningococcal infection
Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Meningococcal Infections
Hepatitis B
DNA Virus Infections
Neisseriaceae Infections

Additional relevant MeSH terms:
Bordetella Infections
Pasteurellaceae Infections
Communicable Diseases
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 04, 2008




Links to all studies - primarily for crawlers