Back to resultsImmune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Tritanrix™-HepB
Rotarix™
Zilbrix™
Triple Antigen™
Engerix™-B
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Diphtheria, Pertussis, Prophylaxis, Hepatitis B diseases, Tetanus
Eligibility Criteria
Inclusion criteria: Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. Administration of one dose of hepatitis B vaccine at birth. A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination. Free of obvious health problems 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Tritanrix™-HepB+Rotarix™ Group
Tritanrix™-HepB+Placebo Group
Zilbrix™+Rotarix™ Group
Zilbrix™+Placebo Group
Triple Antigen™+Engerix™-B Group
Arm Description
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Outcomes
Primary Outcome Measures
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
Secondary Outcome Measures
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values
A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Number of Subjects With Vaccine Response to BPT Antigen
Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen
A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)
A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8
Concentrations of Anti-HBs Antibodies
Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.
Concentrations of Anti-DT Antibodies
Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.
Concentrations of Anti-T Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).
Concentrations of Anti-BPT Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.
Concentrations of Anti-RV Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.
Anti-Polio Type 1, 2, 3 Antibody Titers
Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.
Number of Subjects With Unsolicited Adverse Events (AEs)
Number of subjects with any 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
1. Study Identification
Unique Protocol Identification Number
NCT00158756
Brief Title
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Official Title
A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 12, 2005 (Actual)
Primary Completion Date
November 1, 2006 (Actual)
Study Completion Date
November 23, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens:
One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Diphtheria, Pertussis, Prophylaxis, Hepatitis B diseases, Tetanus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tritanrix™-HepB+Rotarix™ Group
Arm Type
Experimental
Arm Description
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
Arm Title
Tritanrix™-HepB+Placebo Group
Arm Type
Experimental
Arm Description
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
Arm Title
Zilbrix™+Rotarix™ Group
Arm Type
Active Comparator
Arm Description
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
Arm Title
Zilbrix™+Placebo Group
Arm Type
Active Comparator
Arm Description
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
Arm Title
Triple Antigen™+Engerix™-B Group
Arm Type
Active Comparator
Arm Description
Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Intervention Type
Biological
Intervention Name(s)
Tritanrix™-HepB
Other Intervention Name(s)
DTPw-HBV
Intervention Description
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
Intervention Type
Biological
Intervention Name(s)
Rotarix™
Other Intervention Name(s)
HRV vaccine
Intervention Description
GSK Biologicals' live attenuated human rotavirus vaccine
Intervention Type
Biological
Intervention Name(s)
Zilbrix™
Other Intervention Name(s)
DTPw-HBV Kft
Intervention Description
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Intervention Type
Biological
Intervention Name(s)
Triple Antigen™
Other Intervention Name(s)
DTPwcsl vaccine
Intervention Description
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
Intervention Type
Biological
Intervention Name(s)
Engerix™-B
Other Intervention Name(s)
HBV vaccine
Intervention Description
GSK Biologicals' hepatitis B vaccine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for the Rotarix™ vaccine
Primary Outcome Measure Information:
Title
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
Description
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
Time Frame
At one month post dose 3 [PIII(M4)]
Secondary Outcome Measure Information:
Title
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
Description
A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
Description
A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).
Time Frame
At one most post dose 3 [PIII(M4)]
Title
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values
Description
A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Number of Subjects With Vaccine Response to BPT Antigen
Description
Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
Description
A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).
Time Frame
At 2.5 months after dose 2 of Rotarix [PIII(M4)]
Title
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen
Description
A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)
Description
A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Concentrations of Anti-HBs Antibodies
Description
Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Concentrations of Anti-DT Antibodies
Description
Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Concentrations of Anti-T Antibodies
Description
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Concentrations of Anti-BPT Antibodies
Description
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Concentrations of Anti-RV Antibodies
Description
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.
Time Frame
At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Title
Anti-Polio Type 1, 2, 3 Antibody Titers
Description
Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame
At one month post dose 3 [PIII(M4)]
Title
Number of Subjects With Solicited Local Symptoms
Description
Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).
Time Frame
During the 8-Day (Days 0-7) follow-up period
Title
Number of Subjects With Any Solicited General Symptoms
Description
Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.
Time Frame
During the 8-day period (Days 0-7) post-vaccination
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
Number of subjects with any 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.
Time Frame
During the 31-day (Days 0-30) follow-up period
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 Month 0 to Month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
Administration of one dose of hepatitis B vaccine at birth.
A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
Free of obvious health problems 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620003
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ivanteevka Moscow Region
ZIP/Postal Code
141280
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Krasnoyarsk
ZIP/Postal Code
660027
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
129347
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443021
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tomsk
ZIP/Postal Code
634 050
Country
Russian Federation
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
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104021
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
104021
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
104021
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
104021
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
104021
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
104021
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 Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
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