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
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
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014