Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

NCT ID: NCT00674583

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-09
• Study Completion Date: 2009-01-08

Brief Summary

The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Detailed Description

The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Nimenrix Group

Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.

Group Type: EXPERIMENTAL

GSK Biologicals' meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

Intramuscular administration, 1 dose

Menjugate Group

Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.

Group Type: ACTIVE_COMPARATOR

Menjugate

Intervention Type: BIOLOGICAL

Intramuscular administration, 1 dose

Interventions

GSK Biologicals' meningococcal vaccine GSK134612

Intramuscular administration, 1 dose

Intervention Type: BIOLOGICAL

Menjugate

Intramuscular administration, 1 dose

Intervention Type: BIOLOGICAL

Other Intervention Names

MenC-CRM197vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
• Written informed consent obtained from the parent(s) 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

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
• Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
• Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
• Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
• History of meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
• 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 study vaccine dose or planned administration during the study period.

• Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
• Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.

• Minimum Eligible Age: 2 Years
• 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

Draguignan, , France

GSK Investigational Site

Laon, , France

GSK Investigational Site

Le Havre, , France

GSK Investigational Site

Lingolsheim, , France

GSK Investigational Site

Miribel, , France

GSK Investigational Site

Nice, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Saint-Laurent-du-Var, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Vaulx-en-Velin, , France

GSK Investigational Site

Vence, , France

GSK Investigational Site

Tettnang, Baden-Wurttemberg, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Espelkamp, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

GSK Investigational Site

Velbert, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

France; Germany

References

Knuf M, Romain O, Kindler K, Walther U, Tran PM, Pankow-Culot H, Fischbach T, Kieninger-Baum D, Bianco V, Baine Y, Miller J. Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 2013 May;172(5):601-12. doi: 10.1007/s00431-012-1924-0. Epub 2013 Jan 11.

Reference Type: BACKGROUND

PMID: 23307281 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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: 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: Statistical Analysis Plan

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

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

2007-007837-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

111414

Identifier Type: -

Identifier Source: org_study_id