Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00514904

Purpose

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 III

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Non-Inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age

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
Group B: Active Comparator	Biological: Mencevax™ Single dose, subcutaneous injection
Group A: Experimental	Biological: Meningococcal vaccine GSK134612 Single dose, intramuscular 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
New Delhi, India, 110002
GSK Investigational Site
Indore, India, 452001
GSK Investigational Site
Vellore, India, 632004
GSK Investigational Site
Goa, India, 403202
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Philippines
GSK Investigational Site
Manila, Philippines
Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109495
Study First Received:	August 9, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00514904
Health Authority:	India: The Drugs Controller General (India) Directorate General of Health Services, Nirmal Bhavan, New Delhi

Keywords provided by GlaxoSmithKline:

meningococcal vaccine
immunogenicity
safety

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009