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Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Primary Purpose

Infections, Meningococcal

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
meningococcal ACWY (vaccine)
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 Immunogenicity, Healthy, Persistence, Meningococcal vaccine, Non-inferiority, Meningococcal A C W Y Diseases, meningococcal serogroups A, C, W & Y diseases

Eligibility Criteria

11 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. A male or female between, and including, 11 and 55 years of age at the time of vaccination. Written informed consent obtained from the subject/ from the parent or legally acceptable representative 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 knowledge and/or his/her parents/legally acceptable representative's knowledge. If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose. Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years. Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y. History of meningococcal disease due to serogroup A, C, W or Y. 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. History of Guillain-Barré syndrome. 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. Pregnant or lactating female. History of chronic alcohol consumption and/or drug abuse. Female planning to become pregnant or planning to discontinue contraceptive precautions. Specific criteria to be checked at each study visit for the long term follow-up: History of meningococcal serogroup A,C, W and Y disease. Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nimenrix Group

Mencevax Group

Arm Description

Subjects receiving GSK Biologicals' meningococcal vaccine 134612

Subjects receiving Mencevax™ ACWY

Outcomes

Primary Outcome Measures

Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Occurrence of Any Grade 3 Systemic Symptoms
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C.

Secondary Outcome Measures

Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (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 and (≥) 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Concentration of Anti-TT Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/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 = pain that prevented normal activity. 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, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Rash
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
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 SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Full Information

First Posted
July 25, 2006
Last Updated
June 5, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00356369
Brief Title
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Official Title
Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 23, 2006 (Actual)
Primary Completion Date
September 7, 2007 (Actual)
Study Completion Date
February 28, 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives & outcome measures of both the primary & extension phases.
Detailed Description
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Immunogenicity, Healthy, Persistence, Meningococcal vaccine, Non-inferiority, Meningococcal A C W Y Diseases, meningococcal serogroups A, C, W & Y diseases

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nimenrix Group
Arm Type
Experimental
Arm Description
Subjects receiving GSK Biologicals' meningococcal vaccine 134612
Arm Title
Mencevax Group
Arm Type
Active Comparator
Arm Description
Subjects receiving Mencevax™ ACWY
Intervention Type
Biological
Intervention Name(s)
meningococcal ACWY (vaccine)
Intervention Description
One intramuscular dose.
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACWY
Intervention Description
One subcutaneous dose.
Primary Outcome Measure Information:
Title
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Description
Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Time Frame
One month post vaccination
Title
Occurrence of Any Grade 3 Systemic Symptoms
Description
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Secondary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (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 and (≥) 1:128.
Time Frame
Prior to and 1 Month after vaccination
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
Prior to and 1 Month after vaccination
Title
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
Description
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time Frame
Prior to and 1 Month after vaccination
Title
Concentration of Anti-PS Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).
Time Frame
Prior to and 1 Month after vaccination
Title
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Description
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
Prior to and 1 Month after vaccination
Title
Concentration of Anti-TT Antibodies
Description
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time Frame
Prior to and 1 Month after vaccination
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At Year 1
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
At Year 1
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At Year 2
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
At Year 2
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At Year 3
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
At Year 3
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At Year 4
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
At Year 4
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At Year 5
Title
rSBA Antibody Titers
Description
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time Frame
At Year 5
Title
Number of Subjects With Anti-PS Antibodies
Description
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time Frame
At Year 1
Title
Concentration of Anti-PS Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time Frame
At Year 1
Title
Number of Subjects With Anti-PS Antibodies
Description
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time Frame
At Year 2
Title
Concentration of Anti-PS Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time Frame
At Year 2
Title
Number of Subjects With Anti-PS Antibodies
Description
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time Frame
At Year 3
Title
Concentration of Anti-PS Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time Frame
At Year 3
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 = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Description
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame
From Day 0 up to 6 Months after vaccination
Title
Number of Subjects With Rash
Time Frame
From Day 0 up to 6 Months after vaccination
Title
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Time Frame
From Day 0 up to 6 Months after vaccination
Title
Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame
Up to 31 Days after vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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
From Day 0 up to 6 Months after vaccination
Title
Number of Subjects With SAEs
Description
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
At Year 1, Year 2, Year 3, Year 4 and Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. A male or female between, and including, 11 and 55 years of age at the time of vaccination. Written informed consent obtained from the subject/ from the parent or legally acceptable representative 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 knowledge and/or his/her parents/legally acceptable representative's knowledge. If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose. Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years. Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y. History of meningococcal disease due to serogroup A, C, W or Y. 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. History of Guillain-Barré syndrome. 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. Pregnant or lactating female. History of chronic alcohol consumption and/or drug abuse. Female planning to become pregnant or planning to discontinue contraceptive precautions. Specific criteria to be checked at each study visit for the long term follow-up: History of meningococcal serogroup A,C, W and Y disease. Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
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
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
GSK Investigational Site
City
Riyadh
Country
Saudi Arabia

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
26437712
Citation
Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.
Results Reference
derived
PubMed Identifier
23510357
Citation
Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116.
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107386
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
107386
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
107386
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
107386
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
107386
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
107386
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 Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

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