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:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00227422
First received: September 26, 2005
Last updated: May 21, 2009
Last verified: May 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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:
MedlinePlus related topics:
Diphtheria
Haemophilus Infections
Hepatitis
Hepatitis A
Hepatitis B
Meningococcal Infections
Tetanus
Whooping Cough
U.S. FDA Resources
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 |
Intervention Details:
Detailed Description:
-
Biological: Mencevax ACWY
Other Name: Mencevax ACWY
"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
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00227422 History of Changes |
| Other Study ID Numbers: | 102394 |
| Study First Received: | September 26, 2005 |
| Last Updated: | May 21, 2009 |
| Health Authority: | Lebanon: Lebanese Ministry of Health |
Keywords provided by GlaxoSmithKline:
|
Hib diseases Neisseria meningitidis serogroups A & C diseases |
Additional relevant MeSH terms:
|
Diphtheria Haemophilus Infections Hepatitis Hepatitis A Hepatitis B Meningococcal Infections Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Neisseriaceae Infections Bordetella Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on June 18, 2013