Back to resultsNon-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal vaccine GSK134612
Mencevax™ ACWY
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring immunogenicity, safety, meningococcal vaccine
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
- Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.
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 dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Sites / Locations
- 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 Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Subjects of 11-17 years of age who will receive GSK134612
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
Outcomes
Primary Outcome Measures
Number of Subjects With Vaccine Response to Meningococcal Antigens
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
Secondary Outcome Measures
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Meningococcal rSBA Antibody Titers
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Anti-TT Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Anti-meningococcal Polysaccharide Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any Unsolicited Adverse Events
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Specific Adverse Events
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00464815
Brief Title
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Official Title
Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2007 (Actual)
Primary Completion Date
April 16, 2008 (Actual)
Study Completion Date
September 10, 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 demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Detailed Description
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
immunogenicity, safety, meningococcal vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1025 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects of 11-17 years of age who will receive GSK134612
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
Intervention Type
Biological
Intervention Name(s)
Meningococcal vaccine GSK134612
Intervention Description
One intramuscular dose
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACWY
Intervention Description
One subcutaneous dose
Primary Outcome Measure Information:
Title
Number of Subjects With Vaccine Response to Meningococcal Antigens
Description
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
Time Frame
One month post-vaccination (At Month 1)
Title
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
Description
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
Time Frame
During the 4-day (Days 0-3) period after vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Description
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Meningococcal rSBA Antibody Titers
Description
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
Description
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Anti-TT Antibody Concentrations
Description
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
Description
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Anti-meningococcal Polysaccharide Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (Month 0) and one month after vaccination (Month 1)
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
Time Frame
During the 4-day (Days 0-3) period after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
During the 4-day (Days 0-3) period after vaccination
Title
Number of Subjects With Any Unsolicited Adverse Events
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
During the 31-day (Days 0-30) post-vaccination period
Title
Number of Subjects With Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
Up to study end (Month 6)
Title
Number of Subjects With Specific Adverse Events
Description
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Time Frame
Up to study end (Month 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.
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 dose of vaccine.
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
Previous vaccination with tetanus toxoid within the last month.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
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
Goa
ZIP/Postal Code
403202
Country
India
Facility Name
GSK Investigational Site
City
Indore
ZIP/Postal Code
452001
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411 011
Country
India
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Tao Yuan County
ZIP/Postal Code
333
Country
Taiwan
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
21343698
Citation
Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.
Results Reference
derived
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109069
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109069
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109069
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
109069
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109069
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
109069
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
109069
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
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