Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
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
2 other identifiers
interventional
508
2 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 4, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedOctober 7, 2016
October 1, 2016
2.6 years
August 4, 2005
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of meningococcal rSBA responders, in all subjects
One month after the first vaccine dose
Secondary Outcomes (7)
Meningococcal rSBA titres
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
Anti-meningococcal polysaccharide concentrations
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
Anti-tetanus toxoid seropositivity and antibody concentrations
Prior to and one month after administration of the first vaccine dose, in all subjects
Meningococcal hSBA titers
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
Occurrence of local and general solicited adverse events
During the 8-day follow-up period following the administration of each vaccine dose.
- +2 more secondary outcomes
Study Arms (5)
Group A
EXPERIMENTALSubjects of 12-14 months of age or 3-5 years of age who will receive formulation A
Group B
EXPERIMENTALSubjects of 12-14 months of age or 3-5 years of age who will receive formulation B
Group C
EXPERIMENTALSubjects of 12-14 months of age or 3-5 years of age who will receive formulation C
Group D
EXPERIMENTALSubjects of 12-14 months of age or 3-5 years of age who will receive formulation D
Group E
ACTIVE COMPARATORSubjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.
Interventions
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Güssing, A-7540, Austria
GSK Investigational Site
Neufeld/Leitha, A 2491, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
GSK Investigational Site
Villach, A-9500, Austria
GSK Investigational Site
Wels, A-4600, Austria
GSK Investigational Site
Bietigheim-Bissingen, Baden-Wurttemberg, 74321, Germany
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015, Germany
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, 69214, Germany
GSK Investigational Site
Ludwigsburg, Baden-Wurttemberg, 71634, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68309, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Bobingen, Bavaria, 86399, Germany
GSK Investigational Site
Munich, Bavaria, 80939, Germany
GSK Investigational Site
Munich, Bavaria, 81675, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90473, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Tegernsee, Bavaria, 83684, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Weilheim, Bavaria, 82362, Germany
GSK Investigational Site
Bodenheim, Rhineland-Palatinate, 55294, Germany
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Döbeln, Saxony, 04720, Germany
GSK Investigational Site
Dresden, Saxony, 01169, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Stollberg, Saxony, 09366, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 10967, Germany
GSK Investigational Site
Berlin, State of Berlin, 10999, Germany
GSK Investigational Site
Berlin, State of Berlin, 12627, Germany
GSK Investigational Site
Berlin, State of Berlin, 12679, Germany
GSK Investigational Site
Berlin, State of Berlin, 13055, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, Germany
GSK Investigational Site
Berlin, State of Berlin, 14197, Germany
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356, Germany
GSK Investigational Site
Weimar, Thuringia, 99425, Germany
Related Publications (5)
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.
PMID: 19887137BACKGROUNDKnuf 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.
PMID: 22485049BACKGROUNDKnuf 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.
BACKGROUNDPrieler 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.
BACKGROUNDPrieler 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2005
First Posted
August 5, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.