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Phase 3 Completed N=611 Randomized Prevention

Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

Infections, Meningococcal
Source: ClinicalTrials.gov NCT00465816 ↗
Enrolled (actual)
611
Serious AEs
0.8%
Results posted
May 2012
Primary outcomePrimary: Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers — 5263.9; 5211.7; 4344.6; 4926.9 Titer

Summary

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Outcome Measures

OutcomeResultp-value
PRIMARY
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
5263.9; 5211.7; 4344.6; 4926.9; 8922.1; 8987.7
PRIMARY
Number of Subjects Seroconverted for Hepatitis A
321; 95
PRIMARY
Number of Subjects Seroprotected for Hepatitis B
327; 97
SECONDARY
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
246; 76; 333; 101; 346; 112
SECONDARY
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
105; 33; 352; 113; 187; 67
SECONDARY
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
0.25; 0.24; 27.23; 18.47; 0.22; 0.26
SECONDARY
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
45; 13; 179; 54; 32; 13
SECONDARY
Anti-Tetanus Toxoid (TT) Antibody Concentrations
0.800; 1.020; 16.794; 17.252
SECONDARY
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
293; 111; 354; 112
SECONDARY
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
2121.6; 2298.3; 952.4; 1053.9; 3283.4; 3497.7
SECONDARY
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
330; 107; 332; 110; 334; 112
SECONDARY
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
4.14; 3.88; 3.28; 4.15; 2.46; 3.08
SECONDARY
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
160; 52; 157; 52; 157; 51
SECONDARY
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
7.9; 7.6; 5876.7; 6739.0
SECONDARY
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
10; 2; 331; 97
SECONDARY
IgG Anti-HBs Antibody Concentrations
1.7; 1.7; 6088.2; 7654.7
SECONDARY
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
1; 0; 327; 97
SECONDARY
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
181; 58; 75; 19; 71; 18
SECONDARY
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
143; 52; 36; 9; 18; 4
SECONDARY
Number of Subjects Reporting Any Solicited General Symptoms
101; 30; 33; 9; 1; 0
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
62; 13; 18; 26; NA; 7
SECONDARY
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
5; 0; 2
SECONDARY
Number of Subjects Reporting Any Rash
5; 0; 1
SECONDARY
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
1; 0; 0
SECONDARY
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
4; 0; 1

Eligibility Criteria

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 first dose of vaccine.
  • Written informed 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 his/her/the parents'/guardians' knowledge.
  • If the subject is female and 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 completion of the vaccination series.

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.
  • Previous vaccination with hepatitis A and/or hepatitis B vaccine.
  • Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
  • History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
  • Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
  • 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 either vaccine.
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00465816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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