Clinical trial NCT00674583: Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
Official title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Conjugate vaccine
Meningococcal disease
Immunogenicity
Meningococcal vaccine
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 414
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 the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Detailed description: The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

Eligibility criteria: Inclusion Criteria:

* Subjects whose parents/guardians, the investigator believes 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 the vaccination.
* Written informed consent obtained from the parent(s) 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 vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
* Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
* Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* 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 years (for subjects 6 years old and above).
* Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
* History of meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment
* Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period.

Exclusion criteria for specified regions in France

* Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
* Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.

Primary outcomes:
measure: Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody
timeFrame: One month after vaccination (Month 1)
Secondary outcomes:
measure: Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after vaccination (Month 1)
measure: Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Specific Adverse Events
timeFrame: Up to 6 months after vaccination (Month 6)
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: Up to six months after vaccination (Month 6)
Other outcomes:
Locations:
city: Draguignan
country: France
facility: GSK Investigational Site
city: Laon
country: France
facility: GSK Investigational Site
city: Le Havre
country: France
facility: GSK Investigational Site
city: Lingolsheim
country: France
facility: GSK Investigational Site
city: Miribel
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Saint Laurent du Var
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Vaulx en Velin
country: France
facility: GSK Investigational Site
city: Vence
country: France
facility: GSK Investigational Site
city: Tettnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Espelkamp
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hille
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Knuf M, Romain O, Kindler K, Walther U, Tran PM, Pankow-Culot H, Fischbach T, Kieninger-Baum D, Bianco V, Baine Y, Miller J. Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 2013 May;172(5):601-12. doi: 10.1007/s00431-012-1924-0. Epub 2013 Jan 11.