Clinical trial NCT00464815: Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: immunogenicity
safety
meningococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 1025
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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™.

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 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.

Primary outcomes:
measure: Number of Subjects With Vaccine Response to Meningococcal Antigens
timeFrame: One month post-vaccination (At Month 1)
measure: Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
timeFrame: During the 4-day (Days 0-3) period after vaccination
Secondary outcomes:
measure: Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Meningococcal rSBA Antibody Titers
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Anti-TT Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Anti-meningococcal Polysaccharide Concentrations
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) period after vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: Up to study end (Month 6)
measure: Number of Subjects With Specific Adverse Events
timeFrame: Up to study end (Month 6)
Other outcomes:
Locations:
city: Goa
country: India
facility: GSK Investigational Site
city: Indore
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tao Yuan County
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.