A Phase 3 interventional study of Boostrix in Diphtheria-Tetanus-acellular Pertussis Vaccines, sponsored by GlaxoSmithKline. Completed at 8 sites in Russian Federation. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
Among 21 studies testing boostrix in Diphtheria — 3 open to participants now, 3 under way, none of them phase 3. Boostrix · Diphtheria.
Among the 21 studies testing boostrix in Diphtheria, this one is the 12th largest by enrollment, is the only one that started in 2018, is one of 10 in phase 3, and was the 18th registered.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 448 is close to the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →3 of the 21 studies testing boostrix in Diphtheria are open now, in 2 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 10 Diphtheria studies recruiting now, 2 (20%) set no upper age limit and 8 (80%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 4 Years and older · all sexes · healthy volunteers too.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
Median enrollment 460 across the 21 interventional studies. Of the 18 that completed or were terminated, 12 (67%) have results posted.
20 of 21 have an industry lead sponsor. The 4 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
101 studies in Diphtheria by GlaxoSmithKline: none open now, 1 under way, 1 of them phase 3. Of 99 finished, 59 (60%) have results posted.
Among the 101 studies in Diphtheria by GlaxoSmithKline, this one is the 48th largest by enrollment of the 92 interventional ones, is one of 2 that started in 2018, is one of 55 in phase 3, and was the 98th registered.
GlaxoSmithKline’s Diphtheria studies by the year they started, since 1997.
1 of the studies testing boostrix in Diphtheria that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07097012Canadian Immunization Research NetworkConcurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy | 2027-01 |
Among the 21 studies testing boostrix in Diphtheria, from their registry updates:
Among GlaxoSmithKline’s 101 in Diphtheria:
Nothing recorded among them since 2026-09-25.
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.
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:
The inclusion criteria have been amended in order to clarify the following,
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of non- may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Acute disease and/or fever at the time of enrolment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.
Biological: Boostrix
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.
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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 31
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: 1. 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 2. 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.
Time frame: 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: 1. for subjects with pre-vaccination values below (\<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and 2. 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.
Time frame: 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.
Time frame: 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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 31
| Milestone | dTpa Group |
|---|---|
| Started | 447 |
| Completed | 446 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
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.
| Participants | dTpa Group |
|---|---|
| Anti-D antibody ≥ 0.1 IU/ml | 437 |
| Neutralizing anti-D antibody ≥ 0.01 IU/ml | 1 |
A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.
| Participants | dTpa Group |
|---|---|
| Number of Seroprotected Subjects for Anti-tetanus (Anti-T). | 439 |
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.
| Participants | dTpa Group |
|---|---|
| Anti-PT antibody | 430 |
| Anti-FHA antibody | 442 |
| Anti-PRN antibody | 431 |
Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration: 1. 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 2. 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.
| Participants | dTpa Group |
|---|---|
| Anti-D antibody, S- | 26 |
| Anti-D antibody, S+ | 282 |
| Anti-D antibody, Overall | 308 |
| Anti-T antibody, S- | 38 |
| Anti-T antibody, S+ | 338 |
| Anti-T antibody, Overall | 376 |
Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations: 1. for subjects with pre-vaccination values below (\<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and 2. 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.
| Participants | dTpa Group |
|---|---|
| Anti-PT antibody, S- | 138 |
| Anti-PT antibody, S+ (< 4*assay cut-off) | 140 |
| Anti-PT antibody, S+ (≥ 4*assay cut-off) | 97 |
| Anti-PT antibody, Overall | 375 |
| Anti-FHA antibody, S- | 8 |
| Anti-FHA antibody, S+ (< 4*assay cut-off) | 57 |
| Anti-FHA antibody, S+ (≥ 4*assay cut-off) | 345 |
| Anti-FHA antibody, Overall | 410 |
| Anti-PRN antibody, S- | 57 |
| Anti-PRN antibody, S+ (< 4*assay cut-off) | 114 |
| Anti-PRN antibody, S+ (≥ 4*assay cut-off) | 225 |
| Anti-PRN, Overall | 396 |
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.
| IU/mL | dTpa Group |
|---|---|
| Anti-D antibody | 6.287 (5.643 to 7.004) |
| Anti-T antibody | 13.507 (12.138 to 15.031) |
| Anti-PT antibody | 59.279 (52.907 to 66.418) |
| Anti-FHA antibody | 396.938 (362.876 to 434.197) |
| Anti-PRN antibody | 249.638 (213.233 to 292.258) |
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.
| Participants | dTpa Group |
|---|---|
| Pain | 284 |
| Redness | 207 |
| Swelling | 174 |
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.
| Participants | dTpa Group |
|---|---|
| Drowsiness | 1 |
| Irritability/Fussiness | 5 |
| Loss of appetite | 3 |
| Fever ( ≥ 38°C) | 0 |
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.
| Participants | dTpa Group |
|---|---|
| Fatigue | 126 |
| Gastrointestinal symptoms | 34 |
| Headache | 107 |
| Fever ( ≥ 38°C), Overall | 10 |
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.
| Participants | dTpa Group |
|---|---|
| Number of Subjects With Large Swelling Reactions. | 1 |
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.
| Participants | dTpa Group |
|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 52 |
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.
| Participants | dTpa Group |
|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 1 |
Collected over Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| dTpa Group | 0/447 (0%) | 1/447 (0.2%) | 52/447 (11.6%) |
| Event | dTpa Group |
|---|---|
| Pneumonia bacterialInfections and infestations | 1/447 |
| Event | dTpa Group |
|---|---|
| HeadacheNervous system disorders | 12/447 |
| RhinitisInfections and infestations | 7/447 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/447 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 6/447 |
| NauseaGastrointestinal disorders | 3/447 |
| PyrexiaGeneral disorders | 3/447 |
| NasopharyngitisInfections and infestations | 3/447 |
| TracheitisInfections and infestations | 3/447 |
| Injection site pruritusGeneral disorders | 2/447 |
| PharyngitisInfections and infestations | 2/447 |
| Age, Continuous(Years) | dTpa Group |
|---|---|
| Mean | 32.7 ± 27.29 |
| Sex: Female, Male(Participants) | dTpa Group |
|---|---|
| Female | 241 |
| Male | 206 |
| Race/Ethnicity, Customized(Participants) | dTpa Group |
|---|---|
| White - Caucasian / European Heritage | 447 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Jan 2018 to primary completion in Aug 2018, 7 months.
Results were first posted in Oct 2019, 1 year 1 month after primary completion.
Of 46 industry-sponsored phase 3 interventional studies under Diphtheria, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 21. This study's 7 months is below that.
Counting every sponsor, half of 46 studies reached it within 13 months; a quarter within 7 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Boostrix