Phase 3
Completed N=1,025
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00464815 ↗
Enrolled (actual)
1,025
Serious AEs
0.5%
Results posted
Apr 2018
Primary outcomePrimary: Number of Subjects With Vaccine Response to Meningococcal Antigens — 472; 148; 625; 204 Participants
◆ Published Evidence
Established
64citations · ~4 / year
Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults.
Summary
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Linked Publications
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Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Vaccine Response to Meningococcal Antigens |
472; 148; 625; 204; 616; 189 | — |
| PRIMARY Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms |
12; 1 | 0.1456 |
| SECONDARY Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values |
463; 148; 427; 128; 674; 223 | — |
| SECONDARY Meningococcal rSBA Antibody Titers |
208.1; 155.9; 5928.5; 2947.2; 44.1; 40.9 | — |
| SECONDARY Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value |
439; 155; 662; 157 | — |
| SECONDARY Anti-TT Antibody Concentrations |
0.367; 0.41; 10.305; 0.459 | — |
| SECONDARY Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values |
235; 75; 341; 107; 50; 21 | — |
| SECONDARY Anti-meningococcal Polysaccharide Concentrations |
1.05; 1.04; 86.06; 44.06; 0.21; 0.25 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
200; 68; 6; 0; 94; 16 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
109; 36; 7; 1; 83; 26 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events |
72; 26 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs) |
3; 2 | — |
| SECONDARY Number of Subjects With Specific Adverse Events |
6; 1; 0; 0; 1; 0 | — |
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 vaccination.
- Written informed assent/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 the subject's/the subject's parent's/guardian's knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is 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 vaccination.
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.
- 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.
- 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 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 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 (NCT00464815) 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.