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Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00955682
First received: August 6, 2009
Last updated: August 8, 2016
Last verified: August 2016
  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
Infections, Meningococcal
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: December 2009 (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   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955682

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, 01300
GSK Investigational Site
Vantaa, Finland, 01600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Vesikari T et al. Antibody persistence 4 years after vaccination with a quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy toddlers. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May - 1 June 2013.
Vesikari T et al. Immunogenicity and safety after booster vaccination with a quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy children. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May-1 June 2013.
Vesikari T et al. Persistence of immune response to a candidate meningococcal tetravalent tetanus toxoid-conjugate vaccine (MenACWY-TT) in toddlers, 2 years after vaccination. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012. Poster: 682.

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112036
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00955682     History of Changes
Other Study ID Numbers: 112036 
Study First Received: August 6, 2009
Last Updated: August 8, 2016
Health Authority: Finland: Finnish Medicines Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Meningococcal vaccine GSK134612

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016