Clinical trial NCT00454909: Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Official title: Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Meningococcal Serogroups A, C, W-135 and/or Y Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 873
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
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 GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.

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

The protocol posting has been updated following a protocol amendment.

Detailed description: Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (\< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old).

This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to \< 11 years of age.

Eligibility criteria: Inclusion Criteria:

* Subjects whom the investigator believes can and will comply with the requirements of the protocol.
* A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
* Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 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 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 vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
* Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
* Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
* History of meningococcal disease due to serogroup A, C, W-135, or Y.
* 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Hypersensitivity to latex.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Previous history of Guillain-Barré Syndrome.
* Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
* 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 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 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: At Day 0 (PRE)
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: At Month 1
Secondary outcomes:
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
timeFrame: At Day 0 (PRE) and Month 1
measure: hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
timeFrame: At Day 0 (PRE) and Month 1
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period after vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Month 6
measure: Number of Subjects With New Onset Chronic Illness(es) (NOCI)
timeFrame: From Day 0 to Month 6
measure: Number of Subjects Reporting Rash
timeFrame: From Day 0 to Month 6
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: From Day 0 to Month 6
Other outcomes:
Locations:
city: Daly City
country: United States
facility: GSK Investigational Site
state: California
city: Fairfield
country: United States
facility: GSK Investigational Site
state: California
city: Redwood City
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Vallejo
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Waianae
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Waipio
country: United States
facility: GSK Investigational Site
state: Hawaii
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011 Mar;30(3):e41-8. doi: 10.1097/INF.0b013e3182054ab9.
citation: Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.