Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00464815
First received: April 23, 2007
Last updated: September 3, 2009
Last verified: September 2009

April 23, 2007
September 3, 2009
May 2007
April 2008   (final data collection date for primary outcome measure)
  • Vaccine response to meningococcal antigens [ Time Frame: One month post vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any grade 3 systemic symptom [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • 30 days post vaccination: vaccine immunogenicity
  • Up to 4 days post-vaccination: solicited grade 3 AEs
Complete list of historical versions of study NCT00464815 on ClinicalTrials.gov Archive Site
  • Meningococcal rSBA titres [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
  • Anti-tetanus toxoid antibody concentration [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and one month after vaccination, in a randomized subset of subjects ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]
  • Prior to and 30 days post vaccination: antibody concentrations/titres against vaccine antigens
  • Solicited AEs post vaccination (up to day 4)
  • Unsolicited AEs post vaccination (up to day 30)
  • SAEs throughout study
Not Provided
Not Provided
 
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-Inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Serogroups A, C, W-135 and/or Y Disease
  • Biological: Mencevax™ ACWY
    One subcutaneous dose
  • Biological: Meningococcal vaccine GSK134612
    One intramuscular dose
  • Experimental: Group A
    Subjects of 11-17 years of age who will receive GSK134612
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Active Comparator: Group B
    Subjects of 11-17 years of age who will receive MencevaxTM ACWY
    Intervention: Biological: Mencevax™ ACWY
Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. Epub 2011 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1024
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
  • Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with tetanus toxoid within the last month.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • 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.
Both
11 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India,   Philippines,   Taiwan
 
NCT00464815
109069
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2009

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