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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01154088
First received: June 29, 2010
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.


Condition Intervention Phase
Meningococcal Disease.
Biological: Mencevax ACWY
Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity in all subjects with respect to components of the investigational vaccine and the control vaccine [ Time Frame: One month (31 Days) after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity in all subjects with respect to components of the investigational vaccines and the control vaccine (on secondary readouts) [ Time Frame: Prior to and one month (31 Days) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: 4 Days (Days 0-3) following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited non-serious and serious events, and new onset chronic illness. [ Time Frame: 31 Days (Days 0-30) following vaccination ] [ Designated as safety issue: No ]

Enrollment: 1173
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
One dose, Intramuscular injection
Experimental: Group B
Not Applicable
Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
One dose, Intramuscular injection
Active Comparator: Group C
Not applicable
Biological: Mencevax ACWY
One dose, Subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy all of the following criteria at study entry:

  • Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
  • A male or female between, and including, 18 and 25 years of age the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
  • Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
  • Previous vaccination with meningococcal conjugate vaccine.
  • Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
  • History of meningococcal disease.
  • Seropositive for HIV or HBsAg (for subjects in the Philippines only).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 has been demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
  • History of any neurologic disorders, including Guillain-Barré Syndrome.
  • 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.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
  • Concurrently participating 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154088

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01154088     History of Changes
Other Study ID Numbers: 114248
Study First Received: June 29, 2010
Last Updated: November 15, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
Adolescent
Vaccine, conjugate
Adult
Neisseria meningitidis
Immunogenicity
Meningococcal vaccine
Safety

Additional relevant MeSH terms:
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 25, 2014