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

NCT ID: NCT00955682

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-25
• Study Completion Date: 2012-09-10

Brief 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.

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One intramuscular dose (Booster)

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.

Group Type: ACTIVE_COMPARATOR

Meningitec™

Intervention Type: BIOLOGICAL

One intramuscular dose (Booster)

Interventions

Meningococcal vaccine GSK134612

One intramuscular dose (Booster)

Intervention Type: BIOLOGICAL

Meningitec™

One intramuscular dose (Booster)

Intervention Type: BIOLOGICAL

Eligibility 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

• 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.

• 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.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of vaccination.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• 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

Kotka, , Finland

GSK Investigational Site

Kuopio, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Seinäjoki, , 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, 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.

Reference Type: BACKGROUND

PMID: 26780033 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

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: Informed Consent Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Dataset Specification

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2008-003824-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112036

Identifier Type: -

Identifier Source: org_study_id