Phase 3
N=689
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Infections, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT00974363 ↗Enrolled (actual)
689
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups — 404; 132; 404; 131 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood Sampling (Procedure)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups |
230; 80; 209; 74; 203; 30 | — |
| PRIMARY Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups |
230; 80; 209; 74; 203; 30 | — |
| PRIMARY Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups |
230; 80; 209; 74; 203; 30 | — |
| PRIMARY Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups |
230; 80; 209; 74; 203; 30 | — |
| SECONDARY Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups |
403; 128; 398; 118; 335; 99 | — |
| SECONDARY Antibody Titers Against the Vaccine Meningococcal Serogroups |
1493.4; 780.3; 448.3; 206; 386.9; 174.4 | — |
| SECONDARY Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides |
196; 65; 179; 64; 176; 66 | — |
| SECONDARY Antibody Concentrations Against the Vaccine Polysaccharides |
10.16; 18.17; 1.95; 10.88; 3.29; 5.22 | — |
Summary
Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
Data sourced from ClinicalTrials.gov (NCT00974363). 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.