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The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults

Primary Purpose

Infections, Meningococcal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nimenrix
Blood sampling
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 Meningococcal vaccine, Booster vaccination, Immunogenicity, Meningococcal disease, Safety

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Persistence phase:

  • A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909.
  • Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
  • Healthy subjects as established by medical history.
  • Having completed the active phase of the vaccination study with NCT number = 00454909.

Booster phase:

  • Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.

Additional inclusion criterion for the naïve control group:

• A male or female between, and including, 15 and 30 years of age at the time of the vaccination.

Exclusion Criteria:

Persistence phase:

  • Use of any investigational or non-registered product within 30 days of each persistence time point.
  • Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
  • History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
  • Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point.
  • Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
  • Chronic alcohol or drug abuse.
  • Subjects withdrew consent to be contacted for follow-up studies.

Booster phase (to be checked at Year 5 for all subject, including naïve control group):

  • Child in care
  • Not enrolled in the Kaiser Healthcare system.
  • Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior administration of the booster dose.
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
  • History of any meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
  • Concurrently participating 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 a non-investigational product.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
  • History of chronic alcohol consumption and/or drug abuse.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine.
  • Previous vaccination with tetanus and diphtheria toxoids within the last month.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Previous history of Guillain-Barré syndrome
  • Acute disease at the time of vaccination.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
  • For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up studies.

Note: if the subject is female, prior to vaccination 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 on the day of vaccination and continue adequate contraception for 2 months after vaccination.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • 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 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Nimenrix 1 Group

Menactra Group

Nimenrix 2 Group

Nimenrix Naive Group

Nimenrix Pooled Group

Menactra Booster Group

Arm Description

Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination

Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination

Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination

Subjects 15 to <31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study

Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study.

Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study.

Outcomes

Primary Outcome Measures

Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

Secondary Outcome Measures

Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
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.
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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.
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
hSBA Antibody Titers
Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Number of Subjects With 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 New Onset Chronic Illness(es) (NOCIs)
Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Number of Subjects With 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

First Posted
July 11, 2008
Last Updated
November 20, 2014
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00715910
Brief Title
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
Official Title
Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine Versus Menactra® in Healthy Adolescents/Adults Aged 10-25 Years and Booster Response to MenACWY-TT Vaccine Administered at 5 Years Post-primary Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.
Detailed Description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of age. The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination will be evaluated. Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study. This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol Amendment 2, May 2011.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Meningococcal vaccine, Booster vaccination, Immunogenicity, Meningococcal disease, Safety

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nimenrix 1 Group
Arm Type
Experimental
Arm Description
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
Arm Title
Menactra Group
Arm Type
Active Comparator
Arm Description
Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
Arm Title
Nimenrix 2 Group
Arm Type
Experimental
Arm Description
Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
Arm Title
Nimenrix Naive Group
Arm Type
Experimental
Arm Description
Subjects 15 to <31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study
Arm Title
Nimenrix Pooled Group
Arm Type
Experimental
Arm Description
Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study.
Arm Title
Menactra Booster Group
Arm Type
Active Comparator
Arm Description
Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study.
Intervention Type
Biological
Intervention Name(s)
Nimenrix
Other Intervention Name(s)
Meningococcal vaccine GSK134612 (MenACWY-TT)
Intervention Description
One dose, as intramuscular injection
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
Primary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time Frame
At year 1 persistence
Title
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time Frame
At year 3 persistence
Title
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time Frame
At year 5 persistence
Secondary Outcome Measure Information:
Title
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time Frame
At year 1 persistence
Title
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time Frame
At year 3 persistence
Title
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Description
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time Frame
At year 5 persistence
Title
hSBA Antibody Titers
Description
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time Frame
At year 1 persistence
Title
hSBA Antibody Titers
Description
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time Frame
At year 3 persistence
Title
hSBA Antibody Titers
Description
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time Frame
At year 5 persistence
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Description
The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.
Time Frame
At year 1 persistence
Title
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Description
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
Time Frame
At year 1 persistence
Title
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
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
From 6 months up to 1 year following primary vaccination
Title
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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
From 6 months up to 3 years following primary vaccination
Title
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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
From 6 months up to 5 years following primary vaccination
Title
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
Description
The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
Time Frame
1 month post primary (naïve control group) and booster vaccination
Title
hSBA Antibody Titers
Description
Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time Frame
1 month post primary (naïve control group) and booster vaccination
Title
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Description
Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
Time Frame
1 month post primary (naïve control group) and booster vaccination
Title
Number of Subjects With Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Time Frame
During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Title
Number of Subjects With Solicited General Symptoms
Description
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time Frame
During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Title
Number of Subjects With 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
During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination
Title
Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
Description
Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Time Frame
During the 6-month period following the primary (naïve control group) and booster 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
During the 6-month period following the primary (naïve control group) and booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Persistence phase: A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909. Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. Healthy subjects as established by medical history. Having completed the active phase of the vaccination study with NCT number = 00454909. Booster phase: Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. Healthy subjects as established by medical history and history-directed physical examination before entering into the study. If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination. Additional inclusion criterion for the naïve control group: • A male or female between, and including, 15 and 30 years of age at the time of the vaccination. Exclusion Criteria: Persistence phase: Use of any investigational or non-registered product within 30 days of each persistence time point. Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909. History of any meningococcal disease due to serogroup A, B, C, W-135, or Y. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point. Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product. Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. Chronic alcohol or drug abuse. Subjects withdrew consent to be contacted for follow-up studies. Booster phase (to be checked at Year 5 for all subject, including naïve control group): Child in care Not enrolled in the Kaiser Healthcare system. Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior administration of the booster dose. Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909. History of any meningococcal disease. Any confirmed or suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection based on medical history and physical examination. Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination. Concurrently participating 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 a non-investigational product. Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. History of chronic alcohol consumption and/or drug abuse. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine. Previous vaccination with tetanus and diphtheria toxoids within the last month. A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. Major congenital defects or serious chronic illness. History of any neurological disorders or seizures. Previous history of Guillain-Barré syndrome Acute disease at the time of vaccination. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination. For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up studies. Note: if the subject is female, prior to vaccination 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 on the day of vaccination and continue adequate contraception for 2 months after vaccination.
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
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
GSK Investigational Site
City
Fairfield
State/Province
California
ZIP/Postal Code
94533
Country
United States
Facility Name
GSK Investigational Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
GSK Investigational Site
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
GSK Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
GSK Investigational Site
City
Waianae
State/Province
Hawaii
ZIP/Postal Code
96792
Country
United States
Facility Name
GSK Investigational Site
City
Waipio
State/Province
Hawaii
ZIP/Postal Code
96797
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
Results Reference
background
Citation
Baxter R et al. Antibody persistence and safety 3 years after a single dose of MenACWY-TT vaccine in healthy individuals aged 10-25 years. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May-1 June 2013.
Results Reference
background
PubMed Identifier
26237742
Citation
Baxter R, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year Antibody Persistence and Booster Response to a Single Dose of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Young Adults: An Open, Randomized Trial. Pediatr Infect Dis J. 2015 Nov;34(11):1236-43. doi: 10.1097/INF.0000000000000866.
Results Reference
derived

Learn more about this trial

The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults

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