COVID-19Phase 2NCT05940194
NDV-HXP-S Vaccine Clinical Trial (COVIVAC)
A Phase 2 study testing COVIVAC vaccine in people with COVID-19, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.
Trial summary
This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts. After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVIVAC vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Aug 2021to 11 Mar 2022
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years old inclusive at the time of randomization.
- Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
- Has provided written informed consent prior to performance of any study-specific procedure.
- Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
- Resides in study site area and is able and willing to adhere to all protocol visits and procedures.
- If a woman is of childbearing potential age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP.
Who cannot join
- Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
- History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment.
- Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.
- Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
- History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
- History of egg or chicken allergy
Show all 22Show fewer
- History of angioedema
- History of anaphylaxis (≥ grade 2)
- Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C)
- Any abnormal vital sign deemed clinically relevant by the PI
- Abnormality in screening laboratory test deemed exclusionary by the PI in consultation with the Sponsor
- A positive serologic test for hepatitis B (HBsAg) or hepatitis C (HCV Ab) (phase 1 only)
- History of confirmed HIV
- History of laboratory-confirmed COVID-19
- History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
- Any confirmed or suspected immunosuppressive or immunodeficient state
- Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.
- Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted).
- History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies).
- Recent history (within the past year) or signs of alcohol or substance abuse.
- Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
- Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
District Health Center of Vu Thu District
Thái Bình, Thai Binh, 414900
About this study
Official title: A Phase 1/2 Randomized, Active- Controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults ≥ 18 and ≥ 60 Years Old in Vietnam
This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts.
After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2.
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.
Read the detailed description
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to placebo, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results. At least one-third of the subjects in Phase 2 will be aged ≥60 years to ensure that adequate safety and immune data will be available from older and elderly adults to inform the selection of the COVIVAC formulation to advance to Phase 3 studies. The Phase 2 cohort will follow the same visit schedule, and undergo the same procedures and assessments, as in Phase 1. In addition, as exploratory objectives, the anti-NDV HN IgG response will be assessed at V1, V3, V5, and V7 in all subjects, and 36 subjects (equally distributed between the two age strata) will be randomly selected in a 1:1:1 ratio to provide additional blood at V1, V5 and V7 to be used to isolate peripheral blood mononuclear cells (PBMCs) for assessment of T-cell-mediated immunity (CMI).
An interim analysis of Phase 2 data will be conducted after the last subject of the Phase 2 cohort completes V6 (D57) as the basis for selecting the optimal formulation of COVIVAC to advance to Phase 3 studies. As was the case for the Phase 1 interim analysis at the same timepoint, the data generated will include unblinded post-dose 1 and dose 2 safety results for review by the DSMB, and immunogenicity results aggregated by treatment group for review by the Sponsor. The DSMB will consider all accumulated safety data from both phases of the study prior to making any recommendation to the Sponsor that it not advance a formulation based on safety concerns. The Sponsor will ultimately select the formulation to advance to Phase 3 that, in addition to having been judged by the DSMB to have an adequate safety and tolerability profile, is optimal based on relative functional immunogenicity and other programmatic considerations such as those noted above.
- Conditions
- COVID-19
- Being tested
- COVIVAC vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIVAC vaccineBiological
For prevention Covid-19
| Study group | Role | What they receive |
|---|---|---|
| COVIVAC 3 mcg | Experimental | 3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: COVIVAC vaccine |
| COVIVAC 6 mcg | Experimental | 6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: COVIVAC vaccine |
| AZD1222 | Active comparator | AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Receives: Biological: COVIVAC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
- Local solicited AEs: Pain or tenderness, Swelling or induration, Erythema
- Systemic solicited AEs: Fever (defined as oral temperature ≥ 38°C), Headache, Fatigue or malaise, Myalgia, Arthralgia, Nausea or vomiting
- Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Measured: 7 days after each vaccination
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
- An unsolicited adverse event is any AE reported spontaneously by the subject, observed by the study staff during study visits or those identified during review of medical records or source documents. Solicited AEs with an onset after the seven-day solicitation period will be considered unsolicited AEs
- Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Measured: 28 days after each vaccination
Percentage of Participants With SAEs Severity and Relatedness Throughout the Entire Study Period
A SAE is a specific AE that:
- Results in death.
- Is life-threatening.*
- Requires inpatient hospitalization or prolongation of an existing hospitalization.**
- Results in a persistent or significant disability or incapacity.***
- Results in a congenital anomaly or birth defect.
Measured: From the first vaccination until Day 197
Percentage of Participants With AE of Special Interest by Severity and Relatedness Throughout the Entire Study Period
AEs of Special interest which are AEs relevant to COVID-19 and potential immune-mediated medical conditions (PIMMC) occurred throughout the entire study period
Measured: From first vaccination to Day 197
NT50 GMT at 14 Days and 6 Months After Second Vaccination
NT50 GMT against SARS-CoV-2 pseudovirus in subjects who are anti-S IgG seronegative at baseline
Measured: 14 days and 6 months after second vaccination
GMFR in NT50 at 14 Days and 6 Months After Second Vaccination
GMFR in NT50 against SARS-CoV-2 pseudovirus measured at 14 days and 6 months after second vaccination to the baseline
Measured: 14 days and 6 months after second vaccination
Percentage of Subjects With Seroresponse in NT50 at 14 Days and 6 Months After Second Vaccination
Seroresponses against SARS-CoV-2 pseudovirus as defined by a ≥ 4-fold increase from baseline
Measured: 14 days and 6 months after second vaccination
Secondary outcomes (3)
IgG GMC at 14 Days and 6 Months After Second Vaccination
Anti-S IgG GMC in subjects who are anti-S IgG seronegative at baseline
Measured: 14 days and 6 months after the second vaccination
GMFR in Anti-S IgG GMC at 14 Days and 6 Months After Second Vaccination
GMFR in anti-S IgG GMC measured at 14 days and 6 months after second vaccination to the baseline
Measured: 14 days and 6 months after the second vaccination
Percentage of Subjects With Seroresponses in Anti-S IgG Concentration at 14 Days and 6 Months After Second Vaccination
Seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline
Measured: 14 days and 6 months after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start11 Aug 2021
- Primary completion18 Oct 2021
- Study completion11 Mar 2022
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 COVID-19Studies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, Center for Disease Control of Thai Binh Province, Vietnam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940194
- Sponsor's protocol ID
- COVIVAC-0102 (Phase 2)
- Status last verified
- Jun 2024
- First submitted
- 8 Jul 2023
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thiem VD, Anh DD, Ha VH, Van Thom N, Thang TC, Mateus J, Carreno JM, Raghunandan R, Huong NM, Mercer LD, Flores J, Escarrega EA, Raskin A, Thai DH, Van Be L, Sette A, Innis BL, Krammer F, Weiskopf D. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. Vaccine. 2025 Jan 12;44:126542. doi: 10.1016/j.vaccine.2024.126542. Epub 2024 Nov 29.
PubMed 39615342
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized, Active- Controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults ≥ 18 and ≥ 60 Years Old in Vietnam
- ClinicalTrials.gov ID
- NCT05940194
- Acronym / sponsor ID
- COVIVAC-0102 (Phase 2)
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, VietnamIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, Center for Disease Control of Thai Binh Province, Vietnam
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts.
After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2.
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.
Detailed description
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to placebo, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results. At least one-third of the subjects in Phase 2 will be aged ≥60 years to ensure that adequate safety and immune data will be available from older and elderly adults to inform the selection of the COVIVAC formulation to advance to Phase 3 studies. The Phase 2 cohort will follow the same visit schedule, and undergo the same procedures and assessments, as in Phase 1. In addition, as exploratory objectives, the anti-NDV HN IgG response will be assessed at V1, V3, V5, and V7 in all subjects, and 36 subjects (equally distributed between the two age strata) will be randomly selected in a 1:1:1 ratio to provide additional blood at V1, V5 and V7 to be used to isolate peripheral blood mononuclear cells (PBMCs) for assessment of T-cell-mediated immunity (CMI).
An interim analysis of Phase 2 data will be conducted after the last subject of the Phase 2 cohort completes V6 (D57) as the basis for selecting the optimal formulation of COVIVAC to advance to Phase 3 studies. As was the case for the Phase 1 interim analysis at the same timepoint, the data generated will include unblinded post-dose 1 and dose 2 safety results for review by the DSMB, and immunogenicity results aggregated by treatment group for review by the Sponsor. The DSMB will consider all accumulated safety data from both phases of the study prior to making any recommendation to the Sponsor that it not advance a formulation based on safety concerns. The Sponsor will ultimately select the formulation to advance to Phase 3 that, in addition to having been judged by the DSMB to have an adequate safety and tolerability profile, is optimal based on relative functional immunogenicity and other programmatic considerations such as those noted above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVIVAC 3 mcg | Experimental | Biological: COVIVAC vaccine3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
| COVIVAC 6 mcg | Experimental | Biological: COVIVAC vaccine6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
| AZD1222 | Active comparator | Biological: COVIVAC vaccineAZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult ≥ 18 years old inclusive at the time of randomization.
- Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
- Has provided written informed consent prior to performance of any study-specific procedure.
- Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
- Resides in study site area and is able and willing to adhere to all protocol visits and procedures.
Key exclusion criteria (22 listed)
- Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
- History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment.
- Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.
- Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
- History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
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 |
|---|---|---|
| COVIVAC vaccineFor prevention Covid-19 | Biological | AZD1222, COVIVAC 3 mcg, COVIVAC 6 mcg |
Primary outcome
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
Time frame: 7 days after each vaccination
* Local solicited AEs: Pain or tenderness, Swelling or induration, Erythema * Systemic solicited AEs: Fever (defined as oral temperature ≥ 38°C), Headache, Fatigue or malaise, Myalgia, Arthralgia, Nausea or vomiting * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Time frame: 28 days after each vaccination
* An unsolicited adverse event is any AE reported spontaneously by the subject, observed by the study staff during study visits or those identified during review of medical records or source documents. Solicited AEs with an onset after the seven-day solicitation period will be considered unsolicited AEs * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Percentage of Participants With SAEs Severity and Relatedness Throughout the Entire Study Period
Time frame: From the first vaccination until Day 197
A SAE is a specific AE that: * Results in death. * Is life-threatening.* * Requires inpatient hospitalization or prolongation of an existing hospitalization.** * Results in a persistent or significant disability or incapacity.*** * Results in a congenital anomaly or birth defect.
Percentage of Participants With AE of Special Interest by Severity and Relatedness Throughout the Entire Study Period
Time frame: From first vaccination to Day 197
AEs of Special interest which are AEs relevant to COVID-19 and potential immune-mediated medical conditions (PIMMC) occurred throughout the entire study period
NT50 GMT at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after second vaccination
NT50 GMT against SARS-CoV-2 pseudovirus in subjects who are anti-S IgG seronegative at baseline
GMFR in NT50 at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after second vaccination
GMFR in NT50 against SARS-CoV-2 pseudovirus measured at 14 days and 6 months after second vaccination to the baseline
Percentage of Subjects With Seroresponse in NT50 at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after second vaccination
Seroresponses against SARS-CoV-2 pseudovirus as defined by a ≥ 4-fold increase from baseline
3 secondary outcomes
IgG GMC at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after the second vaccination
GMFR in Anti-S IgG GMC at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after the second vaccination
Percentage of Subjects With Seroresponses in Anti-S IgG Concentration at 14 Days and 6 Months After Second Vaccination
Time frame: 14 days and 6 months after the second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39615342Thiem VD, Anh DD, Ha VH, Van Thom N, Thang TC, Mateus J, Carreno JM, Raghunandan R, Huong NM, Mercer LD, Flores J, Escarrega EA, Raskin A, Thai DH, Van Be L, Sette A, Innis BL, Krammer F, Weiskopf D. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial. Vaccine. 2025 Jan 12;44:126542. doi: 10.1016/j.vaccine.2024.126542. Epub 2024 Nov 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVIVAC vaccine in people with COVID-19, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.
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 6 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 15 Jan 2025. 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 Vietnam. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Jan 2025). 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?
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination. (time frame: 7 days after each vaccination). The study lists 7 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 NCT05940194, 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 15 Jan 2025.