Back to resultsImmune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Tritanrix™- HepB
Hiberix™
Mencevax™ ACWY
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring hepatitis B, meningococcal vaccine, pertussis, Prophylaxis diphtheria, meningococcal serogroups A and C diseases, tetanus, Haemophilus influenzae type b
Eligibility Criteria
Inclusion criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. A male or female between, and including, 15 and 24 months of age at the time of vaccination. Written informed consent obtained from the parent or guardian of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, 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 vaccination. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV). Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478). History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 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 including febrile seizures in infancy. Acute disease at the time of enrolment. Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP
TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP
Arm Description
Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Outcomes
Primary Outcome Measures
Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies
Antibody cut-offs were higher than or equal to (≥) 1:128
Secondary Outcome Measures
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128
Anti-rSBA-MenA, C Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs)
Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values
Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).
Anti-PSA, Anti-PSC Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs
The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).
Anti-HBs Concentrations
Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Vaccine Response for rSBA-Men A, C
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.
Number of Subjects With 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00291343
Brief Title
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Official Title
Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2006 (undefined)
Primary Completion Date
March 15, 2007 (Actual)
Study Completion Date
March 15, 2007 (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 be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.
Blood samples will be drawn from subjects as follows:
prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
hepatitis B, meningococcal vaccine, pertussis, Prophylaxis diphtheria, meningococcal serogroups A and C diseases, tetanus, Haemophilus influenzae type b
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP
Arm Type
Experimental
Arm Description
Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Arm Title
TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP
Arm Type
Active Comparator
Arm Description
Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Intervention Type
Biological
Intervention Name(s)
Tritanrix™- HepB
Intervention Description
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Intervention Type
Biological
Intervention Name(s)
Hiberix™
Intervention Description
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACWY
Intervention Description
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Primary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies
Description
Antibody cut-offs were higher than or equal to (≥) 1:128
Time Frame
1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values
Description
Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128
Time Frame
Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Title
Anti-rSBA-MenA, C Antibody Titers
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs)
Time Frame
Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Title
Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values
Description
Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).
Time Frame
Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Title
Anti-PSA, Anti-PSC Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Time Frame
Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.
Title
Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs
Description
The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).
Time Frame
Prior to the Mencevax ACWY vaccination at 24-30 Months of age
Title
Anti-HBs Concentrations
Description
Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).
Time Frame
Prior to the Mencevax ACWY vaccination at 24-30 Months of age
Title
Number of Subjects With Vaccine Response for rSBA-Men A, C
Description
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.
Time Frame
1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).
Title
Number of Subjects With Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.
Time Frame
During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age
Title
Number of Subjects With Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.
Time Frame
During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age
Title
Number of Subjects With 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Time Frame
From Day 0 at months 15-24 of age to study end at Months 25-31 of age
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 15-24 Months of age up to Months 25-31 of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 15 and 24 months of age at the time of vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.
Exclusion criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, 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 vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV).
Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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 including febrile seizures in infancy.
Acute disease at the time of enrolment.
Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY 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
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Sampaloc, Manila
ZIP/Postal Code
1008
Country
Philippines
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.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105239 (mth24-30)
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
105239 (mth24-30)
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
105239 (mth24-30)
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
105239 (mth24-30)
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
105239 (mth24-30)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 105239 are summarised with study 105245 on the GSK Clinical Study Register.
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105239 (mth24-30)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
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