Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

NCT ID: NCT00126984

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-02-29

Brief Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Detailed Description

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Group A

Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A

Group Type: EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination

DTPa/Hib containing vaccine

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Group B

Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B

Group Type: EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination

DTPa/Hib containing vaccine

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Group C

Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C

Group Type: EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination

DTPa/Hib containing vaccine

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Mencevax ACWY

Intervention Type: BIOLOGICAL

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Group D

Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D

Group Type: EXPERIMENTAL

Conjugated meningococcal ACWY-TT (vaccine)

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination

DTPa/Hib containing vaccine

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Group E

Subjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.

Group Type: ACTIVE_COMPARATOR

DTPa/Hib containing vaccine

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Meningitec

Intervention Type: BIOLOGICAL

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Mencevax ACWY

Intervention Type: BIOLOGICAL

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Interventions

Conjugated meningococcal ACWY-TT (vaccine)

One intramuscular dose during the primary vaccination

Intervention Type: BIOLOGICAL

DTPa/Hib containing vaccine

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Intervention Type: BIOLOGICAL

Meningitec

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

Intervention Type: BIOLOGICAL

Mencevax ACWY

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• A male or female between, and including, 12 and 14 months or 3 and 5 years of age at the time of the first 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. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine.
• Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
• Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
• For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life: these booster vaccines will be given at Visit 2.
• History of meningococcal serogroup A, C, W-135 or Y disease.
• Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
• 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 14 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

Güssing, , Austria

GSK Investigational Site

Neufeld/Leitha, , Austria

GSK Investigational Site

Salzburg, , Austria

GSK Investigational Site

Villach, , Austria

GSK Investigational Site

Wels, , Austria

GSK Investigational Site

Bietigheim-Bissingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

GSK Investigational Site

Eppelheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Ludwigsburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, Germany

GSK Investigational Site

Bindlach, Bavaria, Germany

GSK Investigational Site

Bobingen, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Tegernsee, Bavaria, Germany

GSK Investigational Site

Tutzing, Bavaria, Germany

GSK Investigational Site

Weilheim, Bavaria, Germany

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, Germany

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, Germany

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

GSK Investigational Site

Döbeln, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Stollberg, Saxony, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

Countries

Austria; Germany

References

Knuf M, Kieninger-Baum D, Habermehl P, Muttonen P, Maurer H, Vink P, Poolman J, Boutriau D. A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children. Vaccine. 2010 Jan 8;28(3):744-53. doi: 10.1016/j.vaccine.2009.10.064. Epub 2009 Nov 1.

Reference Type: BACKGROUND

PMID: 19887137 (View on PubMed)

Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.

Reference Type: BACKGROUND

PMID: 22485049 (View on PubMed)

Knuf M et al. Antibody persistence and immune memory 15 months after meningococcal tetravalent tetanus toxoid conjugate (ACWY-TT) vaccine in toddlers and 3-5 year-olds. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Reference Type: BACKGROUND

Prieler et al. Immunogenicity of 1 dose of a candidate meningococcal tetravalent tetanus toxoid conjugate (MenACWY-TT) vaccine in 12-14 month and 3-5 year olds. Abstract presented at the 47th Annual Meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, IL, 17-20 September 2007.

Reference Type: BACKGROUND

Prieler et al. Immunogenicity of 1-dose of a new meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine in children 12-14 months and 3-5 years old. Abstract presented at the 9th Meeting of The European Monitoring Group on Meningococci (EMGM). Rome, Italy, 30 May-1 June 2007.

Reference Type: BACKGROUND

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: 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: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 104703 are summarised with study 104704 on 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

104704

Identifier Type: OTHER

Identifier Source: secondary_id

104703 (Primary study)

Identifier Type: -

Identifier Source: org_study_id