Clinical trial NCT00514904: Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Official title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Meningococcal Vaccines
Keywords: safety
meningococcal vaccine
immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 1504
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
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 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.

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 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.

Primary outcomes:
measure: Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
timeFrame: One month after vaccination (Post-vaccination, study Month 1)
measure: Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
timeFrame: During the 4-day (Days 0-3) post-vaccination period
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
timeFrame: Pre vaccination (Month 0) and post vaccination (Month 1)
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
timeFrame: Pre vaccination (Month 0) and post vaccination (Month 1)
measure: Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
timeFrame: Pre vaccination (Month 0) and post vaccination (Month 1)
measure: Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
timeFrame: Pre vaccination (Month 0) and post vaccination (Month 1)
measure: Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
timeFrame: Pre vaccination (Month 0) and post vaccination, (Month 1)
measure: Anti-polysaccharide (Anti-PS) Antibody Concentrations
timeFrame: Pre vaccination (Month 0) and post vaccination (Month 1)
measure: Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after vaccination
measure: Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after vaccination
measure: Number of Subjects < 6 Years of Age With Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after vaccination
measure: Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Specific Adverse Events (AEs)
timeFrame: From Day 0 up to 6 months after vaccination
measure: Number of Subjects Reporting Any Unsolicited Symptoms
timeFrame: Up to one month (Day 0-Day 30) after vaccination
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to 6 months after vaccination
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: Vellore
country: India
facility: GSK Investigational Site
city: Beirut
country: Lebanon
facility: GSK Investigational Site
city: Sampaloc, Manila
country: Philippines
facility: GSK Investigational Site
city: Riyadh
country: Saudi Arabia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.