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

Primary Purpose

Infections, Meningococcal

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Conjugated meningococcal ACWY-TT (vaccine)
DTPa/Hib containing vaccine
Meningitec
Mencevax ACWY
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Meningococcal focused on measuring Safety, Reactogenicity, Immunogenicity, Meningococcal vaccine, Dose selection, Conjugate vaccine

Eligibility Criteria

12 Months - 14 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of meningococcal rSBA responders, in all subjects

Secondary Outcome Measures

Meningococcal rSBA titres
Anti-meningococcal polysaccharide concentrations
Anti-tetanus toxoid seropositivity and antibody concentrations
Meningococcal hSBA titers
Occurrence of local and general solicited adverse events
Occurrence of unsolicited adverse events
Occurrence of any serious adverse events

Full Information

First Posted
August 4, 2005
Last Updated
October 6, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00126984
Brief Title
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
Official Title
A Phase II, Open (Partially Double-blind), Randomized, Controlled Dose-range Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Investigational Vaccination Regimens Versus MENINGITEC™ or MENCEVAX™ ACWY When Given as One Dose to Children Aged 12 to 14 Months and 3 to 5 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Safety, Reactogenicity, Immunogenicity, Meningococcal vaccine, Dose selection, Conjugate vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A
Arm Title
Group B
Arm Type
Experimental
Arm Description
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B
Arm Title
Group C
Arm Type
Experimental
Arm Description
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C
Arm Title
Group D
Arm Type
Experimental
Arm Description
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Subjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.
Intervention Type
Biological
Intervention Name(s)
Conjugated meningococcal ACWY-TT (vaccine)
Intervention Description
One intramuscular dose during the primary vaccination
Intervention Type
Biological
Intervention Name(s)
DTPa/Hib containing vaccine
Intervention Description
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Intervention Type
Biological
Intervention Name(s)
Meningitec
Intervention Description
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Intervention Type
Biological
Intervention Name(s)
Mencevax ACWY
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of meningococcal rSBA responders, in all subjects
Time Frame
One month after the first vaccine dose
Secondary Outcome Measure Information:
Title
Meningococcal rSBA titres
Time Frame
Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Title
Anti-meningococcal polysaccharide concentrations
Time Frame
Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Title
Anti-tetanus toxoid seropositivity and antibody concentrations
Time Frame
Prior to and one month after administration of the first vaccine dose, in all subjects
Title
Meningococcal hSBA titers
Time Frame
Prior to & 1 month after the 1st dose and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Title
Occurrence of local and general solicited adverse events
Time Frame
During the 8-day follow-up period following the administration of each vaccine dose.
Title
Occurrence of unsolicited adverse events
Time Frame
During the 31-day follow-up period following the administration of each vaccine dose.
Title
Occurrence of any serious adverse events
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Guessing
ZIP/Postal Code
A-7540
Country
Austria
Facility Name
GSK Investigational Site
City
Neufeld/Leitha
ZIP/Postal Code
A 2491
Country
Austria
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Villach
ZIP/Postal Code
A-9500
Country
Austria
Facility Name
GSK Investigational Site
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
GSK Investigational Site
City
Bietigheim/Bissingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74321
Country
Germany
Facility Name
GSK Investigational Site
City
Bretten
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75015
Country
Germany
Facility Name
GSK Investigational Site
City
Eppelheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69214
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigsburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71634
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68309
Country
Germany
Facility Name
GSK Investigational Site
City
Oberstenfeld
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71720
Country
Germany
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
Country
Germany
Facility Name
GSK Investigational Site
City
Bobingen
State/Province
Bayern
ZIP/Postal Code
86399
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80939
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81735
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90473
Country
Germany
Facility Name
GSK Investigational Site
City
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Tegernsee
State/Province
Bayern
ZIP/Postal Code
83684
Country
Germany
Facility Name
GSK Investigational Site
City
Tutzing
State/Province
Bayern
ZIP/Postal Code
82327
Country
Germany
Facility Name
GSK Investigational Site
City
Weilheim
State/Province
Bayern
ZIP/Postal Code
82362
Country
Germany
Facility Name
GSK Investigational Site
City
Bodenheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55294
Country
Germany
Facility Name
GSK Investigational Site
City
Gerolstein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54568
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54294
Country
Germany
Facility Name
GSK Investigational Site
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Doebeln
State/Province
Sachsen
ZIP/Postal Code
04720
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01169
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04178
Country
Germany
Facility Name
GSK Investigational Site
City
Stollberg
State/Province
Sachsen
ZIP/Postal Code
09366
Country
Germany
Facility Name
GSK Investigational Site
City
Lobenstein
State/Province
Thueringen
ZIP/Postal Code
07356
Country
Germany
Facility Name
GSK Investigational Site
City
Weimar
State/Province
Thueringen
ZIP/Postal Code
99425
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10999
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12679
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14197
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
19887137
Citation
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.
Results Reference
background
PubMed Identifier
22485049
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
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.
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104703 (Primary study)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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