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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

Primary Purpose

Infections, Meningococcal

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Tritanrix™- HepB
Hiberix™
Mencevax™ ACW
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 serogroups A and C diseases, tetanus, hepatitis B, pertussis, Haemophilus influenzae type b, meningococcal vaccine, Prophylaxis diphtheria

Eligibility Criteria

15 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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 18 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 (CPMS N° 759346/007). 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. Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007). History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W 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 vaccines administered in the study. 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. Axillary temperature ≥ 37.5°C at the time of vaccination. Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period. Anaphylactic reaction following the administration of vaccine in the primary vaccination study. Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

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

AC primed Group

AC unprimed Group

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.

Secondary Outcome Measures

Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Anti-rSBA-MenA, C, W-135 Antibody Titers
Antibody titers were expressed as geometric mean titers (GMTs).
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Anti-PSA and Anti-PSC Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
Antibody concentrations were ≥ 0.3 µg/mL.
Anti-PSW Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Anti-HBs Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
Number of Subjects With Fever
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
Number of Subjects With Solicited Local Symtoms
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Full Information

First Posted
February 3, 2006
Last Updated
April 26, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00317109
Brief Title
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Official Title
Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 19, 2006 (undefined)
Primary Completion Date
May 1, 2007 (Actual)
Study Completion Date
May 17, 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject. Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
meningococcal serogroups A and C diseases, tetanus, hepatitis B, pertussis, Haemophilus influenzae type b, meningococcal vaccine, Prophylaxis diphtheria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC primed Group
Arm Type
Experimental
Arm Title
AC unprimed Group
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Tritanrix™- HepB
Intervention Description
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Intervention Type
Biological
Intervention Name(s)
Hiberix™
Intervention Description
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACW
Intervention Description
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Primary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
Description
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Time Frame
At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Secondary Outcome Measure Information:
Title
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
Description
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Anti-rSBA-MenA, C, W-135 Antibody Titers
Description
Antibody titers were expressed as geometric mean titers (GMTs).
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
Description
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Anti-PSA and Anti-PSC Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Title
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
Description
Antibody concentrations were ≥ 0.3 µg/mL.
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Anti-PSW Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Time Frame
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
Description
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Time Frame
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Time Frame
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Title
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
Description
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
Time Frame
At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Title
Number of Subjects With Fever
Description
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
Time Frame
During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Title
Number of Subjects With Solicited Local Symtoms
Description
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
Time Frame
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Title
Number of Subjects With Solicited General Symptoms
Description
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
Time Frame
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From Months 15-18 and up to Months 25-31 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
18 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 18 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 (CPMS N° 759346/007). 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. Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007). History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W 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 vaccines administered in the study. 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. Axillary temperature ≥ 37.5°C at the time of vaccination. Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period. Anaphylactic reaction following the administration of vaccine in the primary vaccination study. Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
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
Brits
ZIP/Postal Code
0250
Country
South Africa
Facility Name
GSK Investigational Site
City
Ga-Rankuwa
ZIP/Postal Code
0208
Country
South Africa
Facility Name
GSK Investigational Site
City
Rooihuiskraal
ZIP/Postal Code
0145
Country
South Africa

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
104756
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
104756
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
104756
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
104756
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
104756
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
104756
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

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