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
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: 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 July 22, 2014