Back to resultsImmunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
Meningococcal vaccine GSK 134612
MencevaxACWY TM
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Neisseria meningitidis, Meningococcal Vaccines, serogroups A,C, W-135 or Y, meningococcal diseases, meningococcal conjugate vaccine, Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- A male or female 56 years of age or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrent 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 non-investigational product.
- Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
- Any contra-indication to intramuscular and /or subcutaneous injection.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
- Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
- Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
- Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
- History of meningococcal disease due to serogroups A, C, W-135 or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of neurological disorders and seizures
- History of Guillain-Barre syndrome.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
- Pregnant or lactating female.
- Current chronic alcohol consumption and/or drug abuse.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)
Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.
Secondary Outcome Measures
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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 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 New Onset Chronic Illnesses (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01235975
Brief Title
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
Official Title
Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2010 (Actual)
Primary Completion Date
July 29, 2011 (Actual)
Study Completion Date
August 3, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Neisseria meningitidis, Meningococcal Vaccines, serogroups A,C, W-135 or Y, meningococcal diseases, meningococcal conjugate vaccine, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Meningococcal vaccine GSK 134612
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
MencevaxACWY TM
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)
Description
Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.
Time Frame
One month after vaccination (Month 1)
Secondary Outcome Measure Information:
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
Time Frame
At Day 0 and Month 1
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
Time Frame
At Day 0 and Month 1
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
At Day 0 and Month 1
Title
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Time Frame
At Day 0 and Month 1
Title
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
Time Frame
At Day 0 and Month 1
Title
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
Time Frame
At Day 0 and Month 1
Title
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value
Description
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
At Day 0 and Month 1
Title
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame
At Day 0 and Month 1
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame
Within 4 days (Day 0 to 3) post-vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
Within 4 days (Day 0 to 3) post-vaccination
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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
Within 31 days (Day 0 to 30) after vaccination
Title
Number of Subjects With 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
Within 31 days (Day 0 to 30) after vaccination
Title
Number of Subjects With New Onset Chronic Illnesses (NOCI)
Description
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame
Within 31 days (Day 0 to 30) after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol
A male or female 56 years of age or older at the time of the vaccination.
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrent 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 non-investigational product.
Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
Any contra-indication to intramuscular and /or subcutaneous injection.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
History of meningococcal disease due to serogroups A, C, W-135 or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
History of neurological disorders and seizures
History of Guillain-Barre syndrome.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
Pregnant or lactating female.
Current chronic alcohol consumption and/or drug abuse.
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
Beirut
ZIP/Postal Code
1107-2020
Country
Lebanon
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
23494214
Citation
Dbaibo G, El-Ayoubi N, Ghanem S, Hajar F, Bianco V, Miller JM, Mesaros N. Immunogenicity and safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered to adults aged 56 Years and older: results of an open-label, randomized, controlled trial. Drugs Aging. 2013 May;30(5):309-19. doi: 10.1007/s40266-013-0065-0.
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
113807
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
113807
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
113807
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
113807
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
113807
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
113807
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
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