Phase 3
Completed N=611
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
| Outcome | Result | p-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.
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.