Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01165242
First received: July 15, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.


Condition Intervention Phase
Meningococcal Infections
Biological: Meningococcal vaccine GSK 134612
Biological: Menactra®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Menactra® in Healthy Subjects Aged 10-25 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 vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity in all subjects with respect to components of the vaccines [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to 3) following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited non-serious adverse events [ Time Frame: Within 31 days (Day 0 to 30) following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of new onset of chronic illness(es) (NOCI) and serious adverse events (SAEs) [ Time Frame: From Month 0 through Month 6 ] [ Designated as safety issue: No ]

Enrollment: 1013
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects were vaccinated with vaccine GSK134612 Lot A
Biological: Meningococcal vaccine GSK 134612
One intramuscular injection
Experimental: Group B
Subjects were vaccinated with vaccine GSK134612 Lot B
Biological: Meningococcal vaccine GSK 134612
One intramuscular injection
Active Comparator: Group C
Subjects were vaccinated with Menactra®
Biological: Menactra®
One intramuscular injection

  Eligibility

Ages Eligible for Study:   10 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 that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
  • Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.
  • 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 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 (defined as more than 14 days) 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.
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
  • Previous vaccination with vaccine components within the last month.
  • History of meningococcal disease.
  • 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 is demonstrated.
  • History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
  • History of any neurologic disorders, including Guillain-Barré Syndrome.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrollment.
  • 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.
  • Child in care.
  • 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: NCT01165242

  Show 31 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01165242     History of Changes
Other Study ID Numbers: 114249
Study First Received: July 15, 2010
Last Updated: June 23, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis
Adult
Adolescent
Safety
Vaccines, conjugate
Meningococcal vaccines
Immunogenicity

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

ClinicalTrials.gov processed this record on April 17, 2014