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

NCT00674583 | Completed Phase 3 Results

• 2 other identifiers: 1114142007-007837-38
• Study Type: interventional
• Target: 414
• Locations: 2 countries
• Sites: 31

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.

Conditions

Infections, Meningococcal

Keywords

Conjugate vaccine; Meningococcal disease; Immunogenicity; Meningococcal vaccine; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody

  Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

  One month after vaccination (Month 1)

Secondary Outcomes (9)

• Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup

  Prior to (Month 0) and one month after vaccination (Month 1)

• Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations

  Prior to (Month 0) and one month after vaccination (Month 1)

• Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

  During the 4-day (Days 0-3) post-vaccination period

Study Arms (2)

Nimenrix Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' meningococcal vaccine GSK134612

Menjugate Group

ACTIVE COMPARATOR

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.

Biological: Menjugate

Interventions

GSK Biologicals' meningococcal vaccine GSK134612 BIOLOGICAL

Intramuscular administration, 1 dose

Nimenrix Group

Menjugate BIOLOGICAL

Intramuscular administration, 1 dose

Also known as: MenC-CRM197vaccine

Menjugate Group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (31)

GSK Investigational Site

Draguignan, 83300, France

Location

GSK Investigational Site

Laon, 02000, France

Location

GSK Investigational Site

Le Havre, 76600, France

Location

GSK Investigational Site

Lingolsheim, 67380, France

Location

GSK Investigational Site

Miribel, 01700, France

Location

GSK Investigational Site

Nice, 06300, France

Location

GSK Investigational Site

Paris, 75015, France

Location

GSK Investigational Site

Saint-Laurent-du-Var, 06700, France

Location

GSK Investigational Site

Tours, 37000, France

Location

GSK Investigational Site

Vaulx-en-Velin, 69120, France

Location

GSK Investigational Site

Vence, 06140, France

Location

GSK Investigational Site

Tettnang, Baden-Wurttemberg, 88069, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81241, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Espelkamp, North Rhine-Westphalia, 32339, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

Location

GSK Investigational Site

Hille, North Rhine-Westphalia, 32479, Germany

Location

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

Location

GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, 10627, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

Related Publications (1)

• 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.

  PMID: 23307281 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 8, 2008
• Study Start: May 9, 2008
• Primary Completion: September 2, 2008
• Study Completion: January 8, 2009
• Last Updated: November 18, 2019
• Results First Posted: October 19, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (20); FR (11)