Hepatitis BPhase 3NCT00158756
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
A Phase 3 study testing Tritanrix™-HepB, Rotarix™ and Zilbrix™ in people with Hepatitis B, run by GlaxoSmithKline at 9 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tritanrix™-HepB, Rotarix™ and Zilbrix™
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 9 sitesRussia
- Study dates
- 12 Sep 2005to 23 Nov 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
GSK Investigational Site
Barnaul, 656049
GSK Investigational Site
Ivanteevka Moscow Region, 141280
GSK Investigational Site
Krasnoyarsk, 660027
GSK Investigational Site
Moscow, 119991
GSK Investigational Site
Moscow, 129347
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Samara, 443021
GSK Investigational Site
Tomsk, 634 050
GSK Investigational Site
Yekaterinburg, 620003
About this study
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.
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.
Read the 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
- Conditions
- Hepatitis B
- Being tested
- Tritanrix™-HepB, Rotarix™, Zilbrix™, Triple Antigen™, Engerix™-B
- Keywords
- Diphtheria, Pertussis, Prophylaxis, Hepatitis B diseases, Tetanus
- Medical subject headings
- Hepatitis B, Diphtheria, Whooping Cough, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanrix™-HepBBiological
Also called DTPw-HBV
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
Rotarix™Biological
Also called HRV vaccine
GSK Biologicals' live attenuated human rotavirus vaccine
Zilbrix™Biological
Also called DTPw-HBV Kft
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Triple Antigen™Biological
Also called DTPwcsl vaccine
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
Engerix™-BBiological
Also called HBV vaccine
GSK Biologicals' hepatitis B vaccine
PlaceboDrug
Placebo for the Rotarix™ vaccine
| Study group | Role | What they receive |
|---|---|---|
| Tritanrix™-HepB+Rotarix™ Group | Experimental | 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. Receives: Biological: Tritanrix™-HepB; Biological: Rotarix™ |
| Tritanrix™-HepB+Placebo Group | Experimental | 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. Receives: Biological: Tritanrix™-HepB; Drug: Placebo |
| Zilbrix™+Rotarix™ Group | Active comparator | 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. Receives: Biological: Rotarix™; Biological: Zilbrix™ |
| Zilbrix™+Placebo Group | Active comparator | 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. Receives: Biological: Zilbrix™; Drug: Placebo |
| Triple Antigen™+Engerix™-B Group | Active comparator | 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. Receives: Biological: Triple Antigen™; Biological: Engerix™-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one month post dose 3 [PIII(M4)]
Secondary outcomes (17)
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.
Measured: At one month post dose 3 [PIII(M4)]
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).
Measured: 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
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).
Measured: At one month post dose 3 [PIII(M4)]
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.
Measured: At one month post dose 3 [PIII(M4)]
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).
Measured: At 2.5 months after dose 2 of Rotarix [PIII(M4)]
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).
Measured: At one month post dose 3 [PIII(M4)]
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
Measured: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-HBs Antibodies
Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.
Measured: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-DT Antibodies
Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.
Measured: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-T Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).
Measured: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-BPT Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.
Measured: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-RV Antibodies
Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.
Measured: At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Anti-Polio Type 1, 2, 3 Antibody Titers
Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At one month post dose 3 [PIII(M4)]
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).
Measured: During the 8-Day (Days 0-7) follow-up period
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.
Measured: During the 8-day period (Days 0-7) post-vaccination
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.
Measured: During the 31-day (Days 0-30) follow-up period
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.
Measured: From Month 0 to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start12 Sep 2005
- Primary completion1 Nov 2006
- Study completion23 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158756
- Sponsor's protocol ID
- 104021
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2005
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00158756
- Acronym / sponsor ID
- 104021
- Conditions
- Hepatitis B
- Keywords
- Diphtheria, Pertussis, Prophylaxis, Hepatitis B diseases, Tetanus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2005 (actual)
- Primary completion
- 1 Nov 2006 (actual)
- Study completion
- 23 Nov 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tritanrix™-HepB+Rotarix™ Group | Experimental | Biological: Tritanrix™-HepB, Biological: Rotarix™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. |
| Tritanrix™-HepB+Placebo Group | Experimental | Biological: Tritanrix™-HepB, Drug: PlaceboSubjects 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 comparator | Biological: Rotarix™, Biological: Zilbrix™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. |
| Zilbrix™+Placebo Group | Active comparator | Biological: Zilbrix™, Drug: PlaceboSubjects 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 comparator | Biological: Triple Antigen™, Biological: Engerix™-BSubjects 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. |
Who may qualify
- Ages
- 3 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tritanrix™-HepBAlso: DTPw-HBVGSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine. | Biological | Tritanrix™-HepB+Placebo Group, Tritanrix™-HepB+Rotarix™ Group |
| Rotarix™Also: HRV vaccineGSK Biologicals' live attenuated human rotavirus vaccine | Biological | Tritanrix™-HepB+Rotarix™ Group, Zilbrix™+Rotarix™ Group |
| Zilbrix™Also: DTPw-HBV KftGSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine | Biological | Zilbrix™+Placebo Group, Zilbrix™+Rotarix™ Group |
| Triple Antigen™Also: DTPwcsl vaccineCommonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine. | Biological | Triple Antigen™+Engerix™-B Group |
| Engerix™-BAlso: HBV vaccineGSK Biologicals' hepatitis B vaccine | Biological | Triple Antigen™+Engerix™-B Group |
| PlaceboPlacebo for the Rotarix™ vaccine | Drug | Tritanrix™-HepB+Placebo Group, Zilbrix™+Placebo Group |
Primary outcome
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
Time frame: At one month post dose 3 [PIII(M4)]
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.
17 secondary outcomes
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA
Time frame: At one month post dose 3 [PIII(M4)]
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies
Time frame: 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
Time frame: At one month post dose 3 [PIII(M4)]
Number of Subjects With Vaccine Response to BPT Antigen
Time frame: At one month post dose 3 [PIII(M4)]
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values
Time frame: At 2.5 months after dose 2 of Rotarix [PIII(M4)]
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen
Time frame: At one month post dose 3 [PIII(M4)]
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)
Time frame: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-HBs Antibodies
Time frame: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-DT Antibodies
Time frame: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-T Antibodies
Time frame: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-BPT Antibodies
Time frame: At one month post dose 3 [PIII(M4)]
Concentrations of Anti-RV Antibodies
Time frame: At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Anti-Polio Type 1, 2, 3 Antibody Titers
Time frame: At one month post dose 3 [PIII(M4)]
Number of Subjects With Solicited Local Symptoms
Time frame: During the 8-Day (Days 0-7) follow-up period
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 8-day period (Days 0-7) post-vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) follow-up period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tritanrix™-HepB, Rotarix™ and Zilbrix™ in people with Hepatitis B, run by GlaxoSmithKline at 9 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies (time frame: At one month post dose 3 [PIII(M4)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.