|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 Infection Meningococcal Infection |
Biological: Mencevax ACWY |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, 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 |
| Estimated Enrollment: | 324 |
| Study Start Date: | June 2005 |
"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 |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 102394 |
| Study First Received: | September 26, 2005 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00227422 History of Changes |
| Health Authority: | Lebanon: Lebanese Ministry of Health |
|
Hib diseases Neisseria meningitidis serogroups A & C diseases |
|
Bacterial Infections Haemophilus Infections Communicable Diseases Liver Diseases Whooping Cough Hepatitis, Viral, Human Tetanus Infection Hepadnaviridae Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases |
Corynebacterium Infections Meningococcal Infections Hepatitis B Neisseriaceae Infections Pasteurellaceae Infections Diphtheria Actinomycetales Infections Bordetella Infections Hepatitis Virus Diseases Digestive System Diseases DNA Virus Infections Clostridium Infections |