Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
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.
1 other identifier
interventional
308
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Start
First participant enrolled
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2006
CompletedResults Posted
Study results publicly available
July 12, 2017
CompletedJune 6, 2018
April 1, 2017
1.1 years
September 8, 2005
December 20, 2016
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At one month post dose 3 [PIII(M4)]
Secondary Outcomes (17)
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
At one month post dose 3 [PIII(M4)]
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
At one most post dose 3 [PIII(M4)]
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values
At one month post dose 3 [PIII(M4)]
Number of Subjects With Vaccine Response to BPT Antigen
At one month post dose 3 [PIII(M4)]
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
At 2.5 months after dose 2 of Rotarix [PIII(M4)]
- +12 more secondary outcomes
Study Arms (5)
Tritanrix™-HepB+Rotarix™ Group
EXPERIMENTALSubjects 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.
Tritanrix™-HepB+Placebo Group
EXPERIMENTALSubjects 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.
Zilbrix™+Rotarix™ Group
ACTIVE COMPARATORSubjects 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.
Zilbrix™+Placebo Group
ACTIVE COMPARATORSubjects 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.
Triple Antigen™+Engerix™-B Group
ACTIVE COMPARATORSubjects 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.
Interventions
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
GSK Biologicals' live attenuated human rotavirus vaccine
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
GSK Biologicals' hepatitis B vaccine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
Barnaul, 656049, Russia
GSK Investigational Site
Ivanteevka Moscow Region, 141280, Russia
GSK Investigational Site
Krasnoyarsk, 660027, Russia
GSK Investigational Site
Moscow, 119991, Russia
GSK Investigational Site
Moscow, 129347, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Samara, 443021, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Yekaterinburg, 620003, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 12, 2005
Primary Completion
November 1, 2006
Study Completion
November 23, 2006
Last Updated
June 6, 2018
Results First Posted
July 12, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.