Phase 3
Completed N=1,501
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Infections, Meningococcal · Meningococcal Vaccines
Source: ClinicalTrials.gov NCT00514904 ↗
Enrolled (actual)
1,501
Serious AEs
1.5%
Results posted
Oct 2017
Primary outcomePrimary: Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 — 529; 124; 664; 210 Participants
◆ Published Evidence
Established
54citations · ~4 / year
Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile.
Summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Linked Publications
-
Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 |
529; 124; 664; 210; 673; 195 | — |
| PRIMARY Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) |
10; 1 | 0.2202 |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values |
491; 162; 739; 246; 476; 155 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers |
219.1; 227.7; 6343.3; 2283.2; 14.5; 14.2 | — |
| SECONDARY Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values |
635; 220; 733; 218; 296; 107 | — |
| SECONDARY Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations |
0.65; 0.744; 21.731; 0.709 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values |
154; 41; 369; 126; 59; 12 | — |
| SECONDARY Anti-polysaccharide (Anti-PS) Antibody Concentrations |
0.4; 0.29; 81.1; 25.43; 0.18; 0.17 | — |
| SECONDARY Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms |
104; 39; 82; 31; 31; 15 | — |
| SECONDARY Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms |
105; 50; 107; 36; 54; 16 | — |
| SECONDARY Number of Subjects < 6 Years of Age With Solicited General Symptoms |
34; 5; 50; 12; 31; 6 | — |
| SECONDARY Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms |
33; 19; 48; 19; 25; 15 | — |
| SECONDARY Number of Subjects Reporting Specific Adverse Events (AEs) |
45; 16; 3; 1; 15; 4 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Symptoms |
198; 75 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
15; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
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 (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups 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..
- 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 first dose of study vaccine or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00514904) and the linked publication. 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.