DiphtheriaPhase 2/3NCT06708286
A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)
A Phase 2/3 study testing Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Tdcp in people with Diphtheria and Tetanus, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Tdcp
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 30 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Phase II : People ≥ 7 years old
- Phase II : Willing to provide identification documents
- Phase II : Volunteers must obtain informed consent from the volunteers themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
- Phase II : Volunteers aged 7~11 years have completed 4 doses of vaccine containing DPT
- Phase II : ≥12 years old volunteers need to have not received any component vaccine containing DPT within 5 years
- Phase III : People ≥6 years old
Show all 10Show fewer
- Phase III : Willing to provide identification documents
- Phase III : Volunteers must obtain informed consent from themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
- Phase III : Volunteers aged 6~11 years old have completed 4 doses of DPT-containing vaccine in the past
- Phase III : Volunteers aged ≥12 years should not have received any vaccine containing any component of DPT within 5 years
Who cannot join
- Those who have fever before vaccination, with axillary temperature >37.0℃;
- Females with a positive urine pregnancy test or breastfeeding volunteers, volunteers or their partners who have a pregnancy plan within 6 months;
- Suffering from hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication (applicable to people aged 18 years and above);
- Those who have already suffered from one of the diphtheria or tetanus diseases, those who have suffered from whooping cough in the last 3 years; or those who have had persistent cough for 14 days or more in the last 6 months;
- Those who have received vaccine containing pneumococcal polysaccharide/conjugate component within 5 years (applicable to those aged 7 years and above);
- Individuals who have had household contact with an individual with a confirmed diagnosis of pertussis, diphtheria, or tetanus disease in the past 30 days;
Show all 14Show fewer
- Individuals who are allergic to the components of the test vaccine (e.g., aluminum adjuvant, sodium dihydrogen phosphate, sodium chloride, etc.) or who have developed an allergy to the same type of vaccine previously; individuals with a previous history of severe allergy, e.g., recurrent generalized urticaria, anaphylactic shock, respiratory distress, angioneurotic edema, or a history of asthma;
- Those with encephalopathy, uncontrolled epilepsy and other progressive neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases)
- Persons with primary and secondary impaired immune function, receiving immunosuppressive therapy
- Doctor-diagnosed coagulation abnormalities (e.g. coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders
- Currently suffering from severe chronic diseases, acute exacerbation of chronic diseases, acute infectious diseases;
- Have received another investigational drug or vaccine within 1 month prior to receiving the experimental vaccine, or have plans to participate or are participating in a clinical study of any other drug;
- Have received an injectable live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or any other vaccine within 7 days prior to receiving the experimental vaccine;
- In the judgment of the investigator, the volunteer has any other factors that make him/her unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23), Tdcp, PPV23, Diphtheria-tetanus-acellular pertussis vaccine (DTaP)
- Keywords
- Vaccine, Five Components, Immunogenicity, Safety, Acellular
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))Biological
1 dose of Tdcp vaccine (0.5ml) on day 0
23-valent Pneumococcal Polysaccharide Vaccine (PPV23)Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
Diphtheria-tetanus-acellular pertussis vaccine (DTaP)Biological
1 dose of DTaP vaccine (0.5ml) on day 0
| Study group | Role | What they receive |
|---|---|---|
| Phase II, ≥18 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 Receives: Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)) |
| Phase II, ≥18 years old, Control vaccine | Active comparator | One dose of PPV23 on Day 0 Receives: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) |
| Phase II, 7-17 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 Receives: Biological: Tdcp |
| Phase II, 7-17 years old, Control vaccine | Active comparator | One dose of PPV23 on Day 0 Receives: Biological: PPV23 |
| Phase III, ≥18 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 Receives: Biological: Tdcp |
| Phase III, ≥18 years old, Control vaccine | Active comparator | One dose of PPV23 on Day 0 Receives: Biological: PPV23 |
| Phase III, 7-17 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 Receives: Biological: Tdcp |
| Phase III, 7-17 years old, Control vaccine | Active comparator | One dose of PPV23 on Day 0 Receives: Biological: PPV23 |
| Phase III, 6 years old, Experimental vaccine | Experimental | One dose of Tdcp on Day 0 Receives: Biological: Tdcp |
| Phase III, 6 years old, Control vaccine | Active comparator | One dose of DTaP on Day 0 Receives: Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Incidence of adverse reactions
Measured: Within 0-30 days after vaccination
Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Measured: Pre-vaccination and 30 days post-vaccination
Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
Measured: 30 days after vaccination
Phase III: Incidence of adverse reactions
Measured: Within 0-30 days after vaccination
Secondary outcomes (12)
Phase II: Incidence of adverse events/reactions
Measured: Within 30 minutes of vaccination
Phase II: Incidence of adverse events/reactions
Measured: 0-7 days after vaccination
Phase II: Incidence of adverse events
Measured: 0-30 days after vaccination
Phase II: Incidence of serious stadverse events
Measured: Within 6 months of vaccination
Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies
Measured: 30 days after vaccination
Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Measured: 30 days after vaccination
Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Measured: 30 days after vaccination
Phase III: Incidence of adverse events/reactions
Measured: Within 30 minutes of vaccination
Phase III: Incidence of adverse events/reactions
Measured: 0-7 days after vaccination
Phase III: Incidence of adverse events
Measured: 0-30 days after vaccination
Phase III: Incidence of SAEs in subjects aged 7 years and older
Measured: Within 6 months of vaccination
Phase III: Incidence of SAEs in subjects aged 6 years
Measured: Within 12 months of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start20 Dec 2024
- Primary completion1 Jul 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanqing He, Principal investigator, Ethical Review Committee for Clinical Trials of Zhejiang Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708286
- Sponsor's protocol ID
- CTP-Tdcp-002
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
- ClinicalTrials.gov ID
- NCT06708286
- Acronym / sponsor ID
- CTP-Tdcp-002
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- Vaccine, Five Components, Immunogenicity, Safety, Acellular
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase II, ≥18 years old, Experimental vaccine | Experimental | Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))One dose of Tdcp on Day 0 |
| Phase II, ≥18 years old, Control vaccine | Active comparator | Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)One dose of PPV23 on Day 0 |
| Phase II, 7-17 years old, Experimental vaccine | Experimental | Biological: TdcpOne dose of Tdcp on Day 0 |
| Phase II, 7-17 years old, Control vaccine | Active comparator | Biological: PPV23One dose of PPV23 on Day 0 |
| Phase III, ≥18 years old, Experimental vaccine | Experimental | Biological: TdcpOne dose of Tdcp on Day 0 |
| Phase III, ≥18 years old, Control vaccine | Active comparator | Biological: PPV23One dose of PPV23 on Day 0 |
| Phase III, 7-17 years old, Experimental vaccine | Experimental | Biological: TdcpOne dose of Tdcp on Day 0 |
| Phase III, 7-17 years old, Control vaccine | Active comparator | Biological: PPV23One dose of PPV23 on Day 0 |
| Phase III, 6 years old, Experimental vaccine | Experimental | Biological: TdcpOne dose of Tdcp on Day 0 |
| Phase III, 6 years old, Control vaccine | Active comparator | Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP)One dose of DTaP on Day 0 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Phase II : People ≥ 7 years old
- Phase II : Willing to provide identification documents
- Phase II : Volunteers must obtain informed consent from the volunteers themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
- Phase II : Volunteers aged 7~11 years have completed 4 doses of vaccine containing DPT
- Phase II : ≥12 years old volunteers need to have not received any component vaccine containing DPT within 5 years
Key exclusion criteria (14 listed)
- Those who have fever before vaccination, with axillary temperature >37.0℃;
- Females with a positive urine pregnancy test or breastfeeding volunteers, volunteers or their partners who have a pregnancy plan within 6 months;
- Suffering from hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication (applicable to people aged 18 years and above);
- Those who have already suffered from one of the diphtheria or tetanus diseases, those who have suffered from whooping cough in the last 3 years; or those who have had persistent cough for 14 days or more in the last 6 months;
- Those who have received vaccine containing pneumococcal polysaccharide/conjugate component within 5 years (applicable to those aged 7 years and above);
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 |
|---|---|---|
| Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))1 dose of Tdcp vaccine (0.5ml) on day 0 | Biological | Phase II, ≥18 years old, Experimental vaccine |
| 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)1 dose of PPV23 vaccine (0.5ml) on day 0 | Biological | Phase II, ≥18 years old, Control vaccine |
| Tdcp1 dose of Tdcp vaccine (0.5ml) on day 0 | Biological | Phase II, 7-17 years old, Experimental vaccine |
| PPV231 dose of PPV23 vaccine (0.5ml) on day 0 | Biological | Phase II, 7-17 years old, Control vaccine |
| Tdcp1 dose of Tdcp vaccine (0.5ml) on day 0 | Biological | Phase III, ≥18 years old, Experimental vaccine |
| PPV231 dose of PPV23 vaccine (0.5ml) on day 0 | Biological | Phase III, ≥18 years old, Control vaccine |
| Tdcp1 dose of Tdcp vaccine (0.5ml) on day 0 | Biological | Phase III, 7-17 years old, Experimental vaccine |
| PPV231 dose of PPV23 vaccine (0.5ml) on day 0 | Biological | Phase III, 7-17 years old, Control vaccine |
| Tdcp1 dose of Tdcp vaccine (0.5ml) on day 0 | Biological | Phase III, 6 years old, Experimental vaccine |
| Diphtheria-tetanus-acellular pertussis vaccine (DTaP)1 dose of DTaP vaccine (0.5ml) on day 0 | Biological | Phase III, 6 years old, Control vaccine |
Primary outcome
Phase II: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: Pre-vaccination and 30 days post-vaccination
Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
Time frame: 30 days after vaccination
Phase III: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
12 secondary outcomes
Phase II: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase II: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase II: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase II: Incidence of serious stadverse events
Time frame: Within 6 months of vaccination
Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies
Time frame: 30 days after vaccination
Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase III: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase III: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase III: Incidence of SAEs in subjects aged 7 years and older
Time frame: Within 6 months of vaccination
Phase III: Incidence of SAEs in subjects aged 6 years
Time frame: Within 12 months of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Diphtheria
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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.
Hanqing He principal investigator
Ethical Review Committee for Clinical Trials of Zhejiang Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Tdcp in people with Diphtheria and Tetanus, run by CanSino Biologics Inc. at 1 site in China.
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 10 inclusion and 14 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase II: Incidence of adverse reactions (time frame: Within 0-30 days after vaccination). The study lists 4 primary outcomes in all. 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 26 Aug 2026.