Clinical trial NCT00471081: Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
Official title: Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Neisseria meningitidis;
Humans;
Meningococcal vaccines;
Safety
Vaccines, conjugate;
Toddlers;
Immunogenicity;
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 385
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Detailed description: The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion \& Exclusion criteria.

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 of 9 months of age (has not attained 10 months of age) at the time of enrollment.
* Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
* Written informed consent obtained from parents/guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
* Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
* Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
* History of meningococcal diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
* 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.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrollment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: One month after the last dose (at Month 4)
Secondary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: One month after the first dose (at Month 1)
measure: Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
measure: hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
timeFrame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
measure: Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
measure: Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
timeFrame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
measure: Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
timeFrame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
measure: Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
timeFrame: At Month 1 (GSK 134612 s doses Group only) and Month 4
measure: Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
timeFrame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Up to 1 month post-vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Up to study end (Month 9)
measure: Number of Subjects With New Onset Chronic Ilnesses (NOCI)
timeFrame: Up to study end (Month 9)
measure: Number of Subjects Reporting Rash
timeFrame: Up to study end (Month 9)
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: Up to study end (Month 9)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Benton
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Antioch
country: United States
facility: GSK Investigational Site
state: California
city: Fremont
country: United States
facility: GSK Investigational Site
state: California
city: Hayward
country: United States
facility: GSK Investigational Site
state: California
city: Madera
country: United States
facility: GSK Investigational Site
state: California
city: Santa Rosa
country: United States
facility: GSK Investigational Site
state: California
city: Vacaville
country: United States
facility: GSK Investigational Site
state: California
city: Lakewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Littleton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Littleton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Westminster
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Georgia
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Klein NP, Baine Y, Bianco V, Lestrate PR, Naz A, Blatter M, Friedland LR, Miller JM. One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old children. Pediatr Infect Dis J. 2013 Jul;32(7):760-7. doi: 10.1097/INF.0b013e31828693c5.
citation: Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.