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
◆ Published Evidence
Established
80citations · ~5 / year
Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial.
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.
Linked Publications (2)
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Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial.
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Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines.
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-mumps Antibody Concentrations |
3351.2; 3334.1 | — |
| SECONDARY Anti-rubella Antibody Concentrations |
87.2; 117 | — |
| 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 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) 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.