search
Back to results

Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib

Primary Purpose

Hepatitis B, Whole Cell Pertussis, Tetanus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DTPw-HBV/Hib Kft vaccine GSK323527A
Tritanrix™-HepB/Hiberix™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

18 Months - 24 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 should be enrolled in the study. A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study. 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. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster 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 booster vaccine dose. 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 the booster vaccine dose, with the exception of oral polio vaccine (OPV). Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study. History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products during the study period. Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine. Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines. Encephalopathy Axillary temperature of >= 40 °C/ rectal temperature >= 40.5 °C within 48 hours of vaccination. Collapse or shock-like state within 48 hours of vaccination. Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination. Seizures with or without fever occurring within 3 days of vaccination.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
Anti-hepatitis B surface antigen (HBs) antibody concentration
Anti-diphtheria antibody concentration
Anti-tetanus antibody concentration

Secondary Outcome Measures

Anti-Bordetella pertussis (BPT) antibody concentration
Anti-PRP antibody concentration
Anti-HBs antibody concentration
Anti-diphtheria antibody concentration
Anti-tetanus antibody concentration
Anti-BPT antibody concentration
Occurrence of solicited symptoms
Occurrence of unsolicited symptoms
Occurrence of serious adverse events

Full Information

First Posted
May 31, 2006
Last Updated
September 27, 2016
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00332566
Brief Title
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
Official Title
Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Whole Cell Pertussis, Tetanus, Haemophilus Influenzae Type b, Diphtheria

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
DTPw-HBV/Hib Kft vaccine GSK323527A
Intervention Description
Intramuscular injection, 1 dose
Intervention Type
Biological
Intervention Name(s)
Tritanrix™-HepB/Hiberix™
Intervention Description
Intramuscular injection, 1 dose
Primary Outcome Measure Information:
Title
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
Time Frame
One month after the booster dose
Title
Anti-hepatitis B surface antigen (HBs) antibody concentration
Time Frame
One month after the booster dose
Title
Anti-diphtheria antibody concentration
Time Frame
One month after the booster dose
Title
Anti-tetanus antibody concentration
Time Frame
One month after the booster dose
Secondary Outcome Measure Information:
Title
Anti-Bordetella pertussis (BPT) antibody concentration
Time Frame
One month after the booster dose
Title
Anti-PRP antibody concentration
Time Frame
Prior to the booster dose
Title
Anti-HBs antibody concentration
Time Frame
Prior to the booster dose
Title
Anti-diphtheria antibody concentration
Time Frame
Prior to the booster dose
Title
Anti-tetanus antibody concentration
Time Frame
Prior to the booster dose
Title
Anti-BPT antibody concentration
Time Frame
Prior to the booster dose
Title
Occurrence of solicited symptoms
Time Frame
During the 4-day follow-up period after the booster dose
Title
Occurrence of unsolicited symptoms
Time Frame
During the 31-day follow-up period after the booster dose
Title
Occurrence of serious adverse events
Time Frame
During the entire study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 should be enrolled in the study. A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study. 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. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster 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 booster vaccine dose. 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 the booster vaccine dose, with the exception of oral polio vaccine (OPV). Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study. History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products during the study period. Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine. Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines. Encephalopathy Axillary temperature of >= 40 °C/ rectal temperature >= 40.5 °C within 48 hours of vaccination. Collapse or shock-like state within 48 hours of vaccination. Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination. Seizures with or without fever occurring within 3 days of 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
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
GSK Investigational Site
City
Leon
Country
Nicaragua

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
20950456
Citation
Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.
Results Reference
derived
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106602
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
106602
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
106602
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
106602
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
106602
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
106602
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib

We'll reach out to this number within 24 hrs