Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

NCT ID: NCT00427908

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 613 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-07
• Study Completion Date: 2007-12-03

Brief Summary

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.

Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Detailed Description

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

All subjects received GSK Biolgicals' meningococcal vaccine 134612.

Group Type: EXPERIMENTAL

GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)

Intervention Type: BIOLOGICAL

One intramuscular dose.

Group B

Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.

Group Type: ACTIVE_COMPARATOR

Mencevax™ ACWY

Intervention Type: BIOLOGICAL

One subcutaneous dose.

Meningitec™

Intervention Type: BIOLOGICAL

One intramuscular dose.

Interventions

GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)

One intramuscular dose.

Intervention Type: BIOLOGICAL

Mencevax™ ACWY

One subcutaneous dose.

Intervention Type: BIOLOGICAL

Meningitec™

One intramuscular dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
• A male or female between, and including, 1 through 10 years of age at the time of vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.

Exclusion Criteria

For the primary phase:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
• Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
• Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
• History of meningococcal disease due to serogroup A, C, W, or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

For the long term persistence phase:

• History of meningococcal serogroup A, C, W, and/or Y disease.
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Vantaa, , Finland

Countries

Finland

References

Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012 Dec 1;8(12):1882-91. doi: 10.4161/hv.22165. Epub 2012 Oct 2.

Reference Type: BACKGROUND

PMID: 23032168 (View on PubMed)

Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012 Dec 1;8(12):1892-903. doi: 10.4161/hv.22166. Epub 2012 Oct 2.

Reference Type: BACKGROUND

PMID: 23032159 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study is summarised with long term immunogenicity studies 108660 (year 1), 108661 (year 2), 108663 (year 3) and 108665 (year 4) on the GSK Cli

View Document

Related Links

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Other Identifiers

108660 (Y1)

Identifier Type: OTHER

Identifier Source: secondary_id

108661 (Y2)

Identifier Type: OTHER

Identifier Source: secondary_id

108663 (Y3)

Identifier Type: OTHER

Identifier Source: secondary_id

108665 (Y4)

Identifier Type: OTHER

Identifier Source: secondary_id

108668 (Y5)

Identifier Type: OTHER

Identifier Source: secondary_id

108658

Identifier Type: -

Identifier Source: org_study_id