Back to resultsPrimary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nimenrix (Meningococcal vaccine 134612)
Twinrix
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring non-inferiority, adolescents, 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 first dose of vaccine.
- Written informed 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 his/her/the parents'/guardians' knowledge.
- If the subject is female and 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 completion of the vaccination series.
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.
- Previous vaccination with hepatitis A and/or hepatitis B vaccine.
- Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
- History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
- Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
- 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 either vaccine.
- 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Nimenrix + Twinrix Group
Nimenrix Group
Twinrix Group
Arm Description
Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Outcomes
Primary Outcome Measures
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
The rSBA titers were expressed as geometric mean titers (GMTs).
Number of Subjects Seroconverted for Hepatitis A
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Number of Subjects Seroprotected for Hepatitis B
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Secondary Outcome Measures
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
The rSBA titers were expressed as geometric mean titers.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
IgG Anti-HBs Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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.
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Number of Subjects Reporting Any Rash
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465816
Brief Title
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Official Title
Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 11, 2007 (undefined)
Primary Completion Date
April 28, 2008 (Actual)
Study Completion Date
April 28, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
Detailed Description
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
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
non-inferiority, adolescents, meningococcal vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
611 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimenrix + Twinrix Group
Arm Type
Experimental
Arm Description
Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Arm Title
Nimenrix Group
Arm Type
Active Comparator
Arm Description
Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Arm Title
Twinrix Group
Arm Type
Active Comparator
Arm Description
Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Intervention Type
Biological
Intervention Name(s)
Nimenrix (Meningococcal vaccine 134612)
Intervention Description
Single dose intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Twinrix
Intervention Description
3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Primary Outcome Measure Information:
Title
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Description
The rSBA titers were expressed as geometric mean titers (GMTs).
Time Frame
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Title
Number of Subjects Seroconverted for Hepatitis A
Description
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Time Frame
At 1 month after the third dose of Twinrix vaccine (Month 7)
Title
Number of Subjects Seroprotected for Hepatitis B
Description
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Time Frame
At 1 month after the third dose of Twinrix vaccine (Month 7)
Secondary Outcome Measure Information:
Title
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
Description
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].
Time Frame
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
Description
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Title
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Description
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time Frame
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Title
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Description
The cut-off values assessed include 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 with Nimenrix vaccine (Months 0 and 1)
Title
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Description
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Time Frame
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Title
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
Description
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
Time Frame
Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
Description
The rSBA titers were expressed as geometric mean titers.
Time Frame
At 7 months after vaccination with Nimenrix (At Month 7)
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
Description
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame
At 7 months after vaccination with Nimenrix (At Month 7)
Title
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Description
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time Frame
At 7 months after vaccination with Nimenrix (At Month 7)
Title
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Description
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Time Frame
At 7 months after vaccination with Nimenrix (At Month 7)
Title
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Description
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time Frame
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Title
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
Description
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
Time Frame
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Title
IgG Anti-HBs Antibody Concentrations
Description
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time Frame
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Title
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
Description
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Time Frame
Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Title
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Description
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During a 4-day period (Days 0-3) after Nimenrix vaccination
Title
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Description
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Title
Number of Subjects Reporting Any Solicited General Symptoms
Description
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Time Frame
During a 4-day period (Days 0-3) after each vaccine dose and across doses
Title
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description
Unsolicited AE covers any AE 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.
Time Frame
Up to 1 month after each vaccine dose
Title
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
Description
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Time Frame
During the entire study (up to Month 7)
Title
Number of Subjects Reporting Any Rash
Description
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame
During the entire study (up to Month 7)
Title
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Time Frame
During the entire study (up to Month 7)
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
During the entire study (up to Month 7)
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 first dose of vaccine.
Written informed 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 his/her/the parents'/guardians' knowledge.
If the subject is female and 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 completion of the vaccination series.
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.
Previous vaccination with hepatitis A and/or hepatitis B vaccine.
Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
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 either vaccine.
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
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
GSK Investigational Site
City
Karlskrona
ZIP/Postal Code
SE-371 41
Country
Sweden
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
GSK Investigational Site
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Örebro
ZIP/Postal Code
SE-701 16
Country
Sweden
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
22107850
Citation
Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.
Results Reference
background
Citation
Ostergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109063
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
109063
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
109063
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
109063
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
109063
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
109063
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
109063
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
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