Back to resultsStudy to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Primary Purpose
Tetanus, Diphtheria, Acellular Pertussis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Infanrix™/Hib
Infanrix
Hiberix
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus
Eligibility Criteria
Inclusion Criteria:
- A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
- written informed consent obtained from the parent or guardian of the subject
Exclusion Criteria:
- Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
- Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
The vaccine response was defined as it follows:
for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;
for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.
Secondary Outcome Measures
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Concentrations for Anti-D and Anti-T Antibodies
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Concentrations for Anti-PRP Antibodies
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the 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)
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
NCT00412854
Brief Title
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Official Title
Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 3, 2007 (undefined)
Primary Completion Date
June 1, 2007 (Actual)
Study Completion Date
June 25, 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 compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Acellular Pertussis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Infanrix™/Hib
Intervention Type
Biological
Intervention Name(s)
Infanrix
Intervention Type
Biological
Intervention Name(s)
Hiberix
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
Description
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
At Month 3
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
Description
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
Time Frame
At Month 3
Title
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
Description
The vaccine response was defined as it follows:
for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;
for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.
Time Frame
At Month 3
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
Description
The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Time Frame
At Month 3
Title
Concentrations for Anti-D and Anti-T Antibodies
Description
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Time Frame
At Month 0 and Month 3
Title
Concentrations for Anti-PRP Antibodies
Description
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Time Frame
At Month 0 and Month 3
Title
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Description
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
At Month 3
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time Frame
During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
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 (Day 0-30) follow-up period after each vaccination
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 receipt of first dose of study vaccine (Day 0) to study end (Month 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
90 Days
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
written informed consent obtained from the parent or guardian of the subject
Exclusion Criteria:
Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
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
Mengshan
Country
China
Facility Name
GSK Investigational Site
City
Wuzhou
Country
China
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
20575258
Citation
Li YP, Zhang SM, Ye Q. [Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants]. Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104. Chinese.
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104567
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
104567
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
104567
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
104567
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
104567
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
104567
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104567
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
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