Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
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Purpose
Subjects were previously vaccinated at 12 to 23 months of age. This extension study 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Serogroups A, C, W-135 and/or Y Disease |
Biological: Meningococcal vaccine GSK134612 Biological: Meningitec™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers |
- Persistence of immunogenicity with respect to components of the investigational vaccine [ Time Frame: 24, 36, 48 months post primary dose ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the investigational vaccine [ Time Frame: 24, 36 and 48 months post primary dose ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the investigational vaccine [ Time Frame: Prior to, 1 month and 12 months post booster vaccination ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms. [ Time Frame: During the 8-day period (Days 0-7) after booster vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms. [ Time Frame: During the 31-day period (Days 0-30) after booster vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events (SAEs). [ Time Frame: During the 31-day period (Days 0-30) following vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 342 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Subjects who received GSK vaccine 134612 in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
|
Biological: Meningococcal vaccine GSK134612
One intramuscular dose (Booster)
|
|
Active Comparator: Group B
Subjects who received Meningitec™ vaccine in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
|
Biological: Meningitec™
One intramuscular dose (Booster)
|
Detailed Description:
This study will assess the long-term protection offered by the new meningococcal vaccine 134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension study. No new subjects will be enrolled. The subjects will have a blood sample taken at 24, 36 and 48 months after primary vaccination.
At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood samples will be taken 1 and 12 months after the booster vaccination.
Eligibility| Ages Eligible for Study: | 12 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
Exclusion Criteria:
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject's first visit.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study 109670.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study 109670.
- Hypersensitivity to latex.
- Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- Previous vaccination with any component of the vaccines within the last month.
- History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of vaccination.
Contacts and Locations| Finland | |
| GSK Investigational Site | |
| Espoo, Finland, 02100 | |
| GSK Investigational Site | |
| Helsinki, Finland, 00100 | |
| GSK Investigational Site | |
| Helsinki, Finland, 00930 | |
| GSK Investigational Site | |
| Jarvenpaa, Finland, 04400 | |
| GSK Investigational Site | |
| Kotka, Finland, 48600 | |
| GSK Investigational Site | |
| Kuopio, Finland, 70210 | |
| GSK Investigational Site | |
| Lahti, Finland, 15140 | |
| GSK Investigational Site | |
| Oulu, Finland, 90220 | |
| GSK Investigational Site | |
| Pori, Finland, 28100 | |
| GSK Investigational Site | |
| Seinajoki, Finland, 60100 | |
| GSK Investigational Site | |
| Tampere, Finland, 33100 | |
| GSK Investigational Site | |
| Turku, Finland, 20520 | |
| GSK Investigational Site | |
| Vantaa, Finland, 01600 | |
| GSK Investigational Site | |
| Vantaa, Finland, 01300 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00955682 History of Changes |
| Other Study ID Numbers: | 112036 |
| Study First Received: | August 6, 2009 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by GlaxoSmithKline:
|
Meningococcal vaccine GSK134612 |
Additional relevant MeSH terms:
|
Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013