Back to resultsA Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
Primary Purpose
Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis
Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
DTPw-HBV/Hib-MenAC conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Haemophilus Influenzae Type b
Eligibility Criteria
Inclusion criteria: • Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents. Exclusion criteria: Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV). Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period. Chronic administration (> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001. History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.
Secondary Outcome Measures
Pre & 1M post-DTP booster (subset of subjects), antibody levels for all vaccine antigens. Retrospective serious adverse events (SAEs). Solicited (day 0-7), unsolicited events (day 0-30). SAEs (entire study)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00317174
Brief Title
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
Official Title
Assess Immune Persistence & Memory by Giving Plain PRP,PSA & PSC (10 Mths Age), & Immunogenicity & Safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 Booster (15-18 Mths Age) in Previously Primed Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (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 the study is as follows:
To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects.
To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.
Detailed Description
This study will be conducted in two stages:
At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age.
At 15 to 18 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis, Hepatitis B, Diphtheria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
DTPw-HBV/Hib-MenAC conjugate vaccine
Primary Outcome Measure Information:
Title
Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.
Secondary Outcome Measure Information:
Title
Pre & 1M post-DTP booster (subset of subjects), antibody levels for all vaccine antigens. Retrospective serious adverse events (SAEs). Solicited (day 0-7), unsolicited events (day 0-30). SAEs (entire study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
• Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents.
Exclusion criteria:
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period.
Chronic administration (> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001.
History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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
Muntinlupa
ZIP/Postal Code
1781
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.
Citations:
PubMed Identifier
17981067
Citation
Gatchalian S, Palestroque E, De Vleeschauwer I, Han HH, Poolman J, Schuerman L, Dobbelaere K, Boutriau D. The development of a new heptavalent diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C vaccine: a randomized dose-ranging trial of the conjugate vaccine components. Int J Infect Dis. 2008 May;12(3):278-88. doi: 10.1016/j.ijid.2007.08.007. Epub 2007 Nov 5.
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
759346/002
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
759346/002
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
759346/002
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
759346/002
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
759346/002
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
759346/002
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
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