Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00464815

Purpose

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Condition	Intervention	Phase
Meningococcal Serogroups A, C, W-135 and/or Y Disease	Biological: Mencevax™ ACWY Biological: Meningococcal vaccine GSK134612	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:	Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-Inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Vaccine response to meningococcal antigens [ Time Frame: One month post vaccination ] [ Designated as safety issue: No ]
Occurrence of any grade 3 systemic symptom [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Meningococcal rSBA titres [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
Anti-tetanus toxoid antibody concentration [ Time Frame: Prior to and one month after vaccination, in all 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 ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Up to six months after vaccination ] [ 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 ] [ Designated as safety issue: Yes ]

Enrollment:	1024
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects of 11-17 years of age who will receive GSK134612	Biological: Meningococcal vaccine GSK134612 One intramuscular dose
Group B: Active Comparator Subjects of 11-17 years of age who will receive MencevaxTM ACWY	Biological: Mencevax™ ACWY One subcutaneous dose

Detailed Description:

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.

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 within the last five years.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup 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.
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
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 dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464815

Locations

India
GSK Investigational Site
Pune, India, 411 011
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Indore, India, 452001
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Tao Yuan County, Taiwan, 333

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109069
Study First Received:	April 23, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00464815
Health Authority:	Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:

meningococcal vaccine
immunogenicity
safety

ClinicalTrials.gov processed this record on January 16, 2009