Phase 3
Completed N=1,000
Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00474266 ↗
Enrolled (actual)
1,000
Serious AEs
2.8%
Results posted
Dec 2017
Primary outcomePrimary: Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values — 360; 353; 23; 357 Participants
Summary
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values |
360; 353; 23; 357; 353; 118 | — |
| PRIMARY Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values |
361; 0; 118; 0 | — |
| PRIMARY Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values |
306; 0; 97; 0 | — |
| PRIMARY Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values. |
361; 1; 118; 1 | — |
| PRIMARY Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values |
326; 6; 105; 2 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values |
57; 77; 24; 18; 32; 50 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers |
14.6; 22.8; 24.4; 14.3; 2085.9; 2205 | — |
| SECONDARY Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values |
0.17; 0.15; 0.16; 0.16; 28.74; 15.71 | — |
| SECONDARY Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values |
6; 1; 1; 1; 90; 89 | — |
| SECONDARY Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values |
14; 8; 2; 22; 305; 273 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers |
2.1; 2.1; 2; 2.1; 33.7; 19 | — |
| SECONDARY Anti-measles Antibody Concentrations |
7113.8; 8699.8 | — |
| SECONDARY Anti-measles Antibody Concentrations |
7113.8; 8699.8 | — |
| SECONDARY Anti-mumps Antibody Concentrations |
3351.2; 3334.1 | — |
| SECONDARY Anti-mumps Antibody Concentrations |
3351.2; 3334.1 | — |
| SECONDARY Anti-rubella Antibody Concentrations |
87.2; 117 | — |
| SECONDARY Anti-rubella Antibody Concentrations |
87.2; 117 | — |
| SECONDARY Anti-varicella Antibody Titers |
4175.6; 3360.1 | — |
| SECONDARY Anti-varicella Antibody Titers |
4175.6; 3360.1 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination |
75; 22; 126; 48; 28; 7 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 |
91; 107; 31; 133; 136; 39 | — |
| SECONDARY Number of Subjects Reporting Solicited General Symptoms |
122; 103; 29; 40; 56; 34 | — |
| SECONDARY Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms |
295; 164; 99; 56; 1; 0 | — |
| SECONDARY Number of Subjects Reporting Specific Adverse Events (AEs) |
13; 10; 2; 6; 6; 3 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Symptoms |
252; 233; 90; 75 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Symptoms |
252; 233; 90; 75 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
13; 10; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the 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 parents' or legal 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 vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
- Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- History of meningococcal disease.
- Previous vaccination against measles, mumps, rubella, and/or varicella.
- History of measles, mumps, rubella and/or varicella.
- Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- 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 (NCT00474266). 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.