Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 15, 2010
Last updated: August 29, 2016
Last verified: August 2016

July 15, 2010
August 29, 2016
August 2010
February 2011   (Final data collection date for primary outcome measure)
Immunogenicity in all subjects with respect to components of the vaccines [ Time Frame: One month after vaccination (Month 1) ]
Same as current
Complete list of historical versions of study NCT01165242 on Archive Site
  • Immunogenicity in all subjects with respect to components of the vaccines [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to 3) following vaccination ]
  • Occurrence of unsolicited non-serious adverse events [ Time Frame: Within 31 days (Day 0 to 30) following vaccination ]
  • Occurrence of new onset of chronic illness(es) (NOCI) and serious adverse events (SAEs) [ Time Frame: From Month 0 through Month 6 ]
Same as current
Not Provided
Not Provided
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infections, Meningococcal
  • Biological: Meningococcal vaccine GSK 134612
    One intramuscular injection
  • Biological: Menactra®
    One intramuscular injection
  • Experimental: Group A
    Subjects were vaccinated with vaccine GSK134612 Lot A
    Intervention: Biological: Meningococcal vaccine GSK 134612
  • Experimental: Group B
    Subjects were vaccinated with vaccine GSK134612 Lot B
    Intervention: Biological: Meningococcal vaccine GSK 134612
  • Active Comparator: Group C
    Subjects were vaccinated with Menactra®
    Intervention: Biological: Menactra®
Halperin SA, Baine Y, Domachowske JB, Aggarwal N, Simon M, Langley JM, McNeil SA, Friedland LR, Bianco V, Baccarini CI, Miller JM. Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age. J Pediatric Infect Dis Soc. 2014 Mar;3(1):33-42. doi: 10.1093/jpids/pit058. Epub 2013 Oct 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years to 25 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
Not Provided
Not Provided
Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP