Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00514904
First received: August 9, 2007
Last updated: January 12, 2012
Last verified: January 2012
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Purpose
Detailed Description:
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
---|---|---|
Meningococcal Disease |
Biological: Meningococcal vaccine GSK134612 Biological: Mencevax™ |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Non-Inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age |
Resource links provided by NLM:
MedlinePlus related topics:
Meningococcal Infections
Drug Information available for:
Meningococcal Vaccines
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of any grade 3 systemic symptoms [ Time Frame: During the 4-day follow-up period after vaccination, in all subjects ] [ Designated as safety issue: Yes ]
- Vaccine response to meningococcal antigens [ Time Frame: One month after vaccination, in a subset of subjects ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Meningococcal rSBA titres [ Time Frame: Prior to and one month after vaccination, in a subset of subjects ] [ Designated as safety issue: No ]
- Anti-Tetanus toxoid antibody concentrations [ Time Frame: Prior to and one month after vaccination, in a subset of subjects ] [ Designated as safety issue: No ]
- Anti-meningococcal polysaccharide concentrations. [ Time Frame: Prior to and one month after vaccination, in a randomized subset of subjects ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination, in all subjects ] [ Designated as safety issue: Yes ]
- Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination, in all subjects ] [ Designated as safety issue: Yes ]
- Occurrence of serious adverse events [ Time Frame: Up to six months after vaccination, in all subjects ] [ Designated as safety issue: Yes ]
- Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Up to six months after vaccination, in all subjects ] [ Designated as safety issue: Yes ]
Enrollment: | 1505 |
Study Start Date: | September 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Group A |
Biological: Meningococcal vaccine GSK134612
Single dose, intramuscular injection
|
Active Comparator: Group B |
Biological: Mencevax™
Single dose, subcutaneous injection
|
Detailed Description:
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Eligibility
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose 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 first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514904
Locations
India | |
GSK Investigational Site | |
Goa, India, 403202 | |
GSK Investigational Site | |
Indore, India, 452001 | |
GSK Investigational Site | |
New Delhi, India, 110002 | |
GSK Investigational Site | |
Vellore, India, 632004 | |
Lebanon | |
GSK Investigational Site | |
Beirut, Lebanon, 1107-2020 | |
Philippines | |
GSK Investigational Site | |
Sampaloc, Manila, Philippines, 1008 | |
Saudi Arabia | |
GSK Investigational Site | |
Riyadh, Saudi Arabia |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
ClinicalTrials.gov Identifier: | NCT00514904 History of Changes |
Other Study ID Numbers: | 109495 |
Study First Received: | August 9, 2007 |
Last Updated: | January 12, 2012 |
Health Authority: | India: The Drugs Controller General (India) Directorate General of Health Services, Nirmal Bhavan, New Delhi |
Keywords provided by GlaxoSmithKline:
safety meningococcal vaccine immunogenicity |
Additional relevant MeSH terms:
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on October 17, 2012