Last updated: 07/17/2024 15:23:10
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Study to evaluate persistence of antibodies after vaccination with meningococcal vaccine GSK134612

GSK study ID
112036
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Persistence of antibodies after GSK Biologicals’ meningococcal vaccine GSK134612 in toddlers
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: At Month 24 post Nimenrix vaccine

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 36 post Nimenrix vaccine

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 48 post Nimenrix vaccine

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 36 post-primary vaccination.

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 48 post-primary vaccination

Secondary outcomes:

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY titres ≥ the cut-off

Timeframe: At Month 24 post primary dose

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 36 post primary dose

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 48 post primary dose

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Months 24 post primary dose.

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 36 post primary dose

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 48 post primary dose

Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 36 post-primary vaccination

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 48 post-primary vaccination

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 36 post-primary vaccination

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: 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

Timeframe: At Month 24 post primary dose

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

Timeframe: At Month 36 post primary dose.

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

Timeframe: At Month 48 post primary dose

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

Timeframe: At Month 24 post primary dose

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

Timeframe: At Month 36 post primary dose

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

Timeframe: 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

Timeframe: At Month 24 post primary dose

Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

Timeframe: At Month 36 post primary dose

Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values

Timeframe: At Month 48 post primary dose

Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At Month 24 post primary dose

Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At Month 36 post primary dose

Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: 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

Timeframe: 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

Timeframe: At Month 48 post-primary vaccination

Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At Month 36 post-primary vaccination

Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At Month 48 post-primary vaccination.

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: At Month 60 pre-primary vaccination and post-primary vaccination

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At Month 60 pre-primary vaccination and post-primary vaccination

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off

Timeframe: 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

Timeframe: At 12 months (Month 60) post booster dose

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: At one month (Month 49) post booster dose

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres

Timeframe: 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

Timeframe: 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

Timeframe: At 12 months (Month 60) post booster dose.

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

Timeframe: At one month (Month 49) post booster dose

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres

Timeframe: 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

Timeframe: 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

Timeframe: At 12 months (Month 60) post booster dose

Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At one month (Month 49) post booster dose

Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations

Timeframe: At 12 months (Month 60) post booster dose

Number of subjects reporting any solicited local symptoms

Timeframe: During the 8-day period (Days 0-7) after booster vaccination

Number of subjects reporting any solicited general symptoms

Timeframe: During the 8-day period (Days 0-7) after the booster vaccination

Number of subjects reporting any adverse events (AEs)

Timeframe: During the 31-day period (Days 0-30) after booster vaccination

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: At Month 24 post primary dose

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: At Month 36

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: At Month 48

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: At one month (Month 49) post booster dose.

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: At 12 months (Month 60) post booster dose

Interventions:
Biological/vaccine: Meningococcal vaccine GSK134612
Biological/vaccine: Meningitec™
Enrollment:
342
Observational study model:
Not applicable
Primary completion date:
2009-16-12
Time perspective:
Not applicable
Clinical publications:
Vesikari T et al. (2015) Immunogenicity, safety and antibody persistence of a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine compared to monovalent meningococcal serogroup C vaccine administered 4 years after primary vaccination using the same vaccines. Pediatr Infect Dis J. 34(12):e298-307.
Medical condition
Infections, Meningococcal
Product
GSK134612A
Collaborators
Not applicable
Study date(s)
August 2009 to September 2012
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12 - 23 months
Accepts healthy volunteers
Yes
  • 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.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Espoo, Finland, 02100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00930
Status
Study Complete
Location
GSK Investigational Site
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Kotka, Finland, 48600
Status
Study Complete
Location
GSK Investigational Site
Kuopio, Finland, 70210
Status
Study Complete
Location
GSK Investigational Site
Lahti, Finland, 15140
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90220
Status
Study Complete
Location
GSK Investigational Site
Pori, Finland, 28100
Status
Study Complete
Location
GSK Investigational Site
Seinajoki, Finland, 60100
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33100
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Study Complete
Location
GSK Investigational Site
Vantaa, Finland, 01300
Status
Study Complete
Location
GSK Investigational Site
Vantaa, Finland, 01600
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
No longer a GSK study
Actual primary completion date
2009-16-12
Actual study completion date
2012-10-09

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website