Infections, MeningococcalPhase 3NCT00955682
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
A Phase 3 study testing Meningococcal vaccine GSK134612 and Meningitec™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 14 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612 and Meningitec™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 14 sitesFinland
- Study dates
- 25 Aug 2009to 10 Sep 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Finland14 sites
GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kotka, 48600
GSK Investigational Site
Kuopio, 70210
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
GSK Investigational Site
Vantaa, 01600
About this study
Official title: Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers
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.
Read the detailed description
This study will assess the long-term protection offered by the new meningococcal vaccine GSK 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 GSK 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.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612, Meningitec™
- Keywords
- Meningococcal vaccine GSK134612
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612Biological
One intramuscular dose (Booster)
Meningitec™Biological
One intramuscular dose (Booster)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Biological: Meningococcal vaccine GSK134612 |
| Group B | Active comparator | 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. Receives: Biological: Meningitec™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
Measured: At Month 24 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Measured: At Month 36 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Measured: At Month 48 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 36 post-primary vaccination.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 48 post-primary vaccination
Secondary outcomes (46)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.
Measured: At Month 24 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
Measured: At Month 36 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
Measured: At Month 48 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory
Measured: At Months 24 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
Measured: At Month 36 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
Measured: At Month 48 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 36 post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 48 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 36 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 48 post-primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.
Measured: At Month 24 post primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.
Measured: At Month 36 post primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.
Measured: At Month 48 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
Measured: At Month 24 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
Measured: At Month 36 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.
Measured: At Month 48 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.
Measured: At Month 24 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.
Measured: At Month 36 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.
Measured: At Month 48 post primary vaccination
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.
Measured: At Month 24 post primary dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Measured: At Month 36 post primary vaccination
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Measured: At Month 48 post primary dose
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 36 post-primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 48 post-primary vaccination
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.
Measured: At Month 36 post-primary vaccination
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Measured: At Month 48 post-primary vaccination.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
Measured: At one month (Month 49) post booster dose
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
Measured: At 12 months (Month 60) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.
Measured: At one month (Month 49) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.
Measured: At 12 months (Month 60) post booster dose
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.
Measured: At one month (Month 49) post booster dose
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.
Measured: At 12 months (Month 60) post booster dose.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
Measured: At one month (Month 49) post booster dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
Measured: At 12 months (Month 60) post booster dose
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values
The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Measured: At one month (Month 49) post booster dose
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Measured: At 12 months (Month 60) post booster dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Measured: At one month (Month 49) post booster dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Measured: At 12 months (Month 60) post booster dose
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day period (Days 0-7) after booster vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination
Measured: During the 8-day period (Days 0-7) after the booster vaccination
Number of Subjects Reporting Any Adverse Events (AEs)
Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Measured: During the 31-day period (Days 0-30) after booster vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: At Month 24 post primary dose
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: At Month 36
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: At Month 48
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: From month 48 to month 49 (post booster follow up period)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: From month 49 to month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study start25 Aug 2009
- Primary completion16 Dec 2009
- Study completion10 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955682
- Sponsor's protocol ID
- 112036
- Other IDs
- 2008-003824-51, 2008
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2009
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. 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. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
PubMed 26780033
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers
- ClinicalTrials.gov ID
- NCT00955682
- Acronym / sponsor ID
- 112036
- Conditions
- Infections, Meningococcal
- Keywords
- Meningococcal vaccine GSK134612
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2009 (actual)
- Primary completion
- 16 Dec 2009 (actual)
- Study completion
- 10 Sep 2012 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will assess the long-term protection offered by the new meningococcal vaccine GSK 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 GSK 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Meningococcal vaccine GSK134612Subjects 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. |
| Group B | Active comparator | Biological: Meningitec™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. |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal vaccine GSK134612One intramuscular dose (Booster) | Biological | Group A |
| Meningitec™One intramuscular dose (Booster) | Biological | Group B |
Primary outcome
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
Time frame: At Month 24 post primary vaccination
The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 36 post primary vaccination
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 48 post primary vaccination
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 36 post-primary vaccination.
The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 48 post-primary vaccination
The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
46 secondary outcomes
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off
Time frame: At Month 24 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 36 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 48 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Months 24 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 36 post primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 48 post primary vaccination
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 36 post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At Month 48 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 36 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At Month 48 post-primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Time frame: At Month 24 post primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Time frame: At Month 36 post primary vaccination
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Time frame: At Month 48 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Time frame: At Month 24 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Time frame: At Month 36 post primary vaccination
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Time frame: At Month 48 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At Month 24 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At Month 36 post primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At Month 48 post primary vaccination
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At Month 24 post primary dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At Month 36 post primary vaccination
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At Month 48 post primary dose
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At Month 36 post-primary vaccination
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At Month 48 post-primary vaccination
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At Month 36 post-primary vaccination
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At Month 48 post-primary vaccination.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Time frame: At one month (Month 49) post booster dose
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values
Time frame: At 12 months (Month 60) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At one month (Month 49) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Time frame: At 12 months (Month 60) post booster dose
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
Time frame: At one month (Month 49) post booster dose
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
Time frame: At 12 months (Month 60) post booster dose.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Time frame: At one month (Month 49) post booster dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Time frame: At 12 months (Month 60) post booster dose
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values
Time frame: At one month (Month 49) post booster dose
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Time frame: At 12 months (Month 60) post booster dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At one month (Month 49) post booster dose
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At 12 months (Month 60) post booster dose
Number of Subjects Reporting Any Solicited Local Symptoms
Time frame: During the 8-day period (Days 0-7) after booster vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Time frame: During the 8-day period (Days 0-7) after the booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26780033Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. 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. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal vaccine GSK134612 and Meningitec™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 14 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off (time frame: At Month 24 post primary vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.