Diphtheria-Tetanus-acellular Pertussis VaccinesPhase 3NCT03311659
Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects
A Phase 3 study testing Boostrix in people with Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 8 sites in Russia.
Trial summary
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- What is being tested?
- Boostrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 8 sitesRussia
- Study dates
- 26 Jan 2018to 31 Aug 2018
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female four years of age and older.
- Written informed consent obtained from the subject/from the parent(s)/adoptive parent(s) of the subject prior to performing any study specific procedure.
- Written informed assent obtained from subjects aged 14 years to <18 years.
- Healthy subjects as established by medical history and physical examination before entering into the study.
- Children 4-7 years of age with documented previous diphtheria, tetanus and pertussis vaccination (primary series and first booster) as per local recommendation prior to study enrolment, but should have not received any further diphtheria-tetanus containing booster planned at 6-7 years of age as per local recommendations or any other diphtheria, tetanus and pertussis containing vaccine.
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- Subjects eight years of age and older who can report previous diphtheria, tetanus with or without pertussis vaccination - documented or to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge - and did not receive an additional diphtheria, tetanus with or without pertussis vaccination within five years prior to enrolment in the study will be enrolled.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception within 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccination.
Who cannot join
- Child in care
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age.
- History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent. Inhaled and topical steroids are allowed
- Administration of long-acting immune-modifying drugs at any time during the study period.
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- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccine with the exception of inactivated influenza vaccine which can be given at any time during the study conduct as per the Summary of Product Characteristics (SPC) and according to the local governmental recommendations.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilised.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature in this study will be the axilla.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- Acute or chronic, clinically significant uncontrolled pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions during the study conduct.
- Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
GSK Investigational Site
Barnaul, 656056
GSK Investigational Site
Gatchina, 188300
GSK Investigational Site
Moscow, 115478
GSK Investigational Site
Moscow, 129515
GSK Investigational Site
Murmansk, 183038
GSK Investigational Site
Saint Petersburg, 191025
GSK Investigational Site
Yaroslavl, 150051
GSK Investigational Site
Yekaterinburg, 620137
About this study
Official title: Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' dTpa Booster Vaccine (263855) (Boostrix) Administered as a Booster Dose in Healthy Russian Subjects
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy Russian subjects. An equal number of subjects are expected to be recruited in the following age categories: 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis diseases.
Read the detailed description
The study is a phase III, open-label, self-contained, multi-centre, uncontrolled, single-country study with a single group. Treatment will be allocated in a non-randomised process and stratified by age as 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). The study will consist of a single primary epoch (001) starting at Visit 1 (Day 1) with the administration of a single dose of Boostrix vaccine and ending at Visit 2 (Day 31). Blood samples will be collected at Visits 1 and 2.
Protocol Amendment 1 was developed to implement the following changes:
- Wording "parents/Legally Acceptable Representative(s) (LAR[s])" was replaced by the wording "parent(s)/adoptive parent(s)". As per Russian legislation, only parents or adoptive parents can give consent for the enrolment of their child in a clinical trial. No other person is allowed to give consent on behalf of a minor to participate in a clinical trial.
- The age groups at inclusion to study were amended according to the approved Boostrix EU label and physiological particularities i.e., from 3-9 to 4-9 years (children), 10-19 to 10-17 years (adolescents), 20-64 to 18-64 years (adults) and ≥65 years (elderly population).
- The inclusion criteria have been amended in order to clarify the following,
- Children from four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations will be enrolled
- Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within five years prior to enrolment in the study will be enrolled.
Protocol amendment 2 was developed after the comments from the Russian regulatory authorities [Ministry of Health (MoH)]. Adjustments to the text were made to clarify the inclusion and exclusion criteria for enrolment of subjects and the conduct of the study. In addition, adjustments for the reporting period and assessment of adverse events in the safety sections were made for consistency. The newly re-developed and re-validated GSK's DTPa ELISA cut-offs were updated as per the most recent CBER recommendation (2017).
Protocol amendment 3 is developed to accommodate older adults (approximately 58 years old and older) who were born before national recommendations in Russia for infant DTP vaccination. Adjustments to the text are made in the inclusion criteria to clarify the enrolment of subjects for age group eight years and above.
- Being tested
- Boostrix
- Keywords
- Diphtheria, Pertussis, Tetanus, Immunogenicity
- Medical subject headings
- Diphtheria, Whooping Cough, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostrixBiological
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.
| Study group | Role | What they receive |
|---|---|---|
| dTpa group | Experimental | Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1. Receives: Biological: Boostrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D).
A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations <0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.
Measured: At Day 31
Number of Seroprotected Subjects for Anti-tetanus (Anti-T).
A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.
Measured: At Day 31
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
Measured: At Day 31
Secondary outcomes (9)
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens
Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration:
- for subjects with values <0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations of at least ≥0.4 IU/ml, one month after vaccination; and
- for subjects with values ≥0.1 IU/ml (i.e. equal to or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination.
Measured: At Day 31
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens.
Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations:
- for subjects with pre-vaccination values below (<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and
- for subjects with pre-vaccination values between the assay cut-off and <4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration.
Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN respectively.
Measured: At Day 31
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination.
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively.
Measured: At Day 31
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as > 0 millimeters (mm) diameter for all subjects.
Measured: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects Aged Below 6 Years With Solicited General Symptoms.
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥ 38.0 degrees Celsius (°C). The location for measuring temperature was the axilla.
Measured: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms.
Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 °C.
Measured: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects With Large Swelling Reactions.
Large injection site reaction for subjects < 6 years of age defined as a swelling with a diameter of > 50 mm and for subjects ≥ 6 years of age swelling with a diameter of > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination.
Measured: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: During the 31-day (Day 1-31) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 1 to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start26 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diphtheria-Tetanus-acellular Pertussis VaccinesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 448 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
- NCT03311659
- Sponsor's protocol ID
- 201532
- Other IDs
- 2015-003405-42, 2015
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2017
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Asatryan A, Meyer N, Scherbakov M, Romanenko V, Osipova I, Galustyan A, Shamsheva O, Latysheva T, Myasnikova T, Baudson N, Dodet M, Xavier S, Harrington L, Kuznetsova A, Campora L, Van den Steen P. Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study. Hum Vaccin Immunother. 2021 Mar 4;17(3):723-730. doi: 10.1080/21645515.2020.1796423. Epub 2020 Aug 26.
PubMed 32845735
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' dTpa Booster Vaccine (263855) (Boostrix) Administered as a Booster Dose in Healthy Russian Subjects
- ClinicalTrials.gov ID
- NCT03311659
- Acronym / sponsor ID
- 201532
- Keywords
- Diphtheria, Pertussis, Tetanus, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy Russian subjects. An equal number of subjects are expected to be recruited in the following age categories: 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis diseases.
Detailed description
The study is a phase III, open-label, self-contained, multi-centre, uncontrolled, single-country study with a single group. Treatment will be allocated in a non-randomised process and stratified by age as 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). The study will consist of a single primary epoch (001) starting at Visit 1 (Day 1) with the administration of a single dose of Boostrix vaccine and ending at Visit 2 (Day 31). Blood samples will be collected at Visits 1 and 2.
Protocol Amendment 1 was developed to implement the following changes:
- Wording "parents/Legally Acceptable Representative(s) (LAR[s])" was replaced by the wording "parent(s)/adoptive parent(s)". As per Russian legislation, only parents or adoptive parents can give consent for the enrolment of their child in a clinical trial. No other person is allowed to give consent on behalf of a minor to participate in a clinical trial.
- The age groups at inclusion to study were amended according to the approved Boostrix EU label and physiological particularities i.e., from 3-9 to 4-9 years (children), 10-19 to 10-17 years (adolescents), 20-64 to 18-64 years (adults) and ≥65 years (elderly population).
- The inclusion criteria have been amended in order to clarify the following,
- Children from four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations will be enrolled
- Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within five years prior to enrolment in the study will be enrolled.
Protocol amendment 2 was developed after the comments from the Russian regulatory authorities [Ministry of Health (MoH)]. Adjustments to the text were made to clarify the inclusion and exclusion criteria for enrolment of subjects and the conduct of the study. In addition, adjustments for the reporting period and assessment of adverse events in the safety sections were made for consistency. The newly re-developed and re-validated GSK's DTPa ELISA cut-offs were updated as per the most recent CBER recommendation (2017).
Protocol amendment 3 is developed to accommodate older adults (approximately 58 years old and older) who were born before national recommendations in Russia for infant DTP vaccination. Adjustments to the text are made in the inclusion criteria to clarify the enrolment of subjects for age group eight years and above.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dTpa group | Experimental | Biological: BoostrixHealthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female four years of age and older.
- Written informed consent obtained from the subject/from the parent(s)/adoptive parent(s) of the subject prior to performing any study specific procedure.
- Written informed assent obtained from subjects aged 14 years to <18 years.
- Healthy subjects as established by medical history and physical examination before entering into the study.
Key exclusion criteria (22 listed)
- Child in care
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age.
- History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent. Inhaled and topical steroids are allowed
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 |
|---|---|---|
| BoostrixOne dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group. | Biological | dTpa group |
Primary outcome
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D).
Time frame: At Day 31
A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations <0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.
Number of Seroprotected Subjects for Anti-tetanus (Anti-T).
Time frame: At Day 31
A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
Time frame: At Day 31
A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
9 secondary outcomes
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens
Time frame: At Day 31
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens.
Time frame: At Day 31
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination.
Time frame: At Day 31
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects Aged Below 6 Years With Solicited General Symptoms.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects With Large Swelling Reactions.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 1-31) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32845735Asatryan A, Meyer N, Scherbakov M, Romanenko V, Osipova I, Galustyan A, Shamsheva O, Latysheva T, Myasnikova T, Baudson N, Dodet M, Xavier S, Harrington L, Kuznetsova A, Campora L, Van den Steen P. Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study. Hum Vaccin Immunother. 2021 Mar 4;17(3):723-730. doi: 10.1080/21645515.2020.1796423. Epub 2020 Aug 26.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request 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
8 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 Boostrix in people with Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 8 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 13 inclusion and 22 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 23 Oct 2019). 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?
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). (time frame: At Day 31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311659, which also lists 1 linked publication.
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 27 Oct 2020.