InfluenzaPhase 1/2NCT06821061
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
A Phase 1/2 study testing Investigational Influenza Vaccine, Investigational COVID-19 Vaccine and Investigational Influenza and COVID-19 Combination Vaccine in people with Influenza and COVID-19 (Coronavirus Disease 2019), run by BioNTech SE at 31 sites in United States.
Trial summary
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, COVID-19 (Coronavirus Disease 2019)
- What is being tested?
- Investigational Influenza Vaccine, Investigational COVID-19 Vaccine and Investigational Influenza and COVID-19 Combination Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,650 participants
- Where
- 31 sitesUnited States
- Study dates
- 10 Feb 2025to 17 Dec 2025
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 18 years of age or older
- Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study
Who cannot join
- Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
- Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
- Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.
- Refer to the study contact for further eligibility details
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Clinical Research Professionals
Chesterfield, Missouri, 63005
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213
Alliance for Multispecialty Research, LLC
Doral, Florida, 33172
Upstate Global Health Institute
East Syracuse, New York, 13057
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
East-West Medical Research Institute
Honolulu, Hawaii, 96814
DM Clinical Research- Cyfair
Houston, Texas, 77065
AMR Clinical
Knoxville, Tennessee, 37909
AMR Clinical
Knoxville, Tennessee, 37920
Orange County Research Center
Lake Forest, California, 92630
SMS Clinical Research
Mesquite, Texas, 75149
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Clinical Research Consulting
Milford, Connecticut, 06460
Clinical Research Associates Inc
Nashville, Tennessee, 37203
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
Artemis Institute for Clinical Research
Riverside, California, 92503
University of Rochester Medical Center
Rochester, New York, 14642
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Artemis Institute for Clinical Research
San Diego, California, 92103
Kaiser Permanente Washington Health Research Institute (KPWHRI)
Seattle, Washington, 98101
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403
About this study
Official title: A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.
This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
- Conditions
- Influenza, COVID-19 (Coronavirus Disease 2019)
- Being tested
- Investigational Influenza Vaccine, Investigational COVID-19 Vaccine, Investigational Influenza and COVID-19 Combination Vaccine, Licensed Influenza Vaccine 1, Licensed Influenza Vaccine 2
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Influenza VaccineBiological
Investigational Influenza Vaccine
Investigational COVID-19 VaccineBiological
Investigational COVID-19 Vaccine
Investigational Influenza and COVID-19 Combination VaccineCombination product
Investigational Combined Influenza and COVID-19 Vaccine
Licensed Influenza Vaccine 1Biological
Licensed Influenza Vaccine 1
Licensed Influenza Vaccine 2Biological
Licensed Influenza Vaccine 2
Licensed Influenza Vaccine 3Biological
Licensed Influenza Vaccine 3
Licensed COVID-19 VaccineBiological
Pfizer-BioNTech COVID-19 Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Low Dose COVID-19 Vaccine (1a) Receives: Biological: Investigational COVID-19 Vaccine |
| Arm B | Experimental | Low Dose COVID-19 Vaccine ( 1b) Receives: Biological: Investigational COVID-19 Vaccine |
| Arm C | Experimental | Low Dose COVID-19 Vaccine ( 1c) Receives: Biological: Investigational COVID-19 Vaccine |
| Arm D | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm E | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm F | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm G | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm H | Active comparator | Licensed COVID-19 Vaccine Receives: Biological: Licensed COVID-19 Vaccine |
| Arm I | Active comparator | Licensed Influenza Vaccine (1) Receives: Biological: Licensed Influenza Vaccine 1 |
| Arm J | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm K | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm L | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm M | Active comparator | Licensed COVID-19 Vaccine Receives: Biological: Licensed COVID-19 Vaccine |
| Arm N | Active comparator | Licensed Influenza Vaccine (2) Receives: Biological: Licensed Influenza Vaccine 2 |
| Arm AA | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm BB | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm CC | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm DD | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm EE | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm FF | Active comparator | Licensed COVID-19 Vaccine Receives: Biological: Licensed COVID-19 Vaccine |
| Arm GG | Active comparator | Licensed Influenza Vaccine (3) Receives: Biological: Licensed Influenza Vaccine 3 |
| Arm HH | Active comparator | Licensed Influenza Vaccine (2) Receives: Biological: Licensed Influenza Vaccine 2 |
| Arm II | Experimental | Low Dose COVID-19 Vaccine ( 1b) Receives: Biological: Investigational COVID-19 Vaccine |
| Arm JJ | Experimental | Low Dose COVID-19 Vaccine ( 1c) Receives: Biological: Investigational COVID-19 Vaccine |
| Arm KK | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm LL | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm MM | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm NN | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm OO | Experimental | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) Receives: Combination Product: Investigational Influenza and COVID-19 Combination Vaccine |
| Arm PP | Experimental | Medium Dose Investigational Influenza Vaccine (1) Receives: Biological: Investigational Influenza Vaccine |
| Arm QQ | Experimental | High Dose Investigational Influenza Vaccine (2) Receives: Biological: Investigational Influenza Vaccine |
| Arm RR | Active comparator | Licensed COVID-19 Vaccine Receives: Biological: Licensed COVID-19 Vaccine |
| Arm SS | Active comparator | Licensed Influenza Vaccine (3) Receives: Biological: Licensed Influenza Vaccine 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Measured: Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Measured: Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Measured: 1 month
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
Measured: 6 months
Secondary outcomes (1)
GMTs before and through 1 month following investigational product administration
Measured: Before vaccination through to 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Feb 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821061
- Sponsor's protocol ID
- C6271001
- Other IDs
- C6271001-C1, C6271001-C1A
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
- ClinicalTrials.gov ID
- NCT06821061
- Acronym / sponsor ID
- C6271001
- Conditions
- Influenza, COVID-19 (Coronavirus Disease 2019)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,650 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 11 Feb 2025 (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.
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.
This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 33
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Investigational COVID-19 VaccineLow Dose COVID-19 Vaccine (1a) |
| Arm B | Experimental | Biological: Investigational COVID-19 VaccineLow Dose COVID-19 Vaccine ( 1b) |
| Arm C | Experimental | Biological: Investigational COVID-19 VaccineLow Dose COVID-19 Vaccine ( 1c) |
| Arm D | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1) |
| Arm E | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm F | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm G | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm H | Active comparator | Biological: Licensed COVID-19 VaccineLicensed COVID-19 Vaccine |
| Arm I | Active comparator | Biological: Licensed Influenza Vaccine 1Licensed Influenza Vaccine (1) |
| Arm J | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) |
| Arm K | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) |
| Arm L | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm M | Active comparator | Biological: Licensed COVID-19 VaccineLicensed COVID-19 Vaccine |
| Arm N | Active comparator | Biological: Licensed Influenza Vaccine 2Licensed Influenza Vaccine (2) |
| Arm AA | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) |
| Arm BB | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm CC | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm DD | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm EE | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm FF | Active comparator | Biological: Licensed COVID-19 VaccineLicensed COVID-19 Vaccine |
| Arm GG | Active comparator | Biological: Licensed Influenza Vaccine 3Licensed Influenza Vaccine (3) |
| Arm HH | Active comparator | Biological: Licensed Influenza Vaccine 2Licensed Influenza Vaccine (2) |
| Arm II | Experimental | Biological: Investigational COVID-19 VaccineLow Dose COVID-19 Vaccine ( 1b) |
| Arm JJ | Experimental | Biological: Investigational COVID-19 VaccineLow Dose COVID-19 Vaccine ( 1c) |
| Arm KK | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm LL | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm MM | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm NN | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm OO | Experimental | Combination Product: Investigational Influenza and COVID-19 Combination VaccineInvestigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) |
| Arm PP | Experimental | Biological: Investigational Influenza VaccineMedium Dose Investigational Influenza Vaccine (1) |
| Arm QQ | Experimental | Biological: Investigational Influenza VaccineHigh Dose Investigational Influenza Vaccine (2) |
| Arm RR | Active comparator | Biological: Licensed COVID-19 VaccineLicensed COVID-19 Vaccine |
| Arm SS | Active comparator | Biological: Licensed Influenza Vaccine 3Licensed Influenza Vaccine (3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants 18 years of age or older
- Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study
Key exclusion criteria (4 listed)
- Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
- Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
- Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1.
- Refer to the study contact for further eligibility details
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 |
|---|---|---|
| Investigational Influenza VaccineInvestigational Influenza Vaccine | Biological | Arm PP, Arm QQ |
| Investigational COVID-19 VaccineInvestigational COVID-19 Vaccine | Biological | Arm A, Arm B, Arm C, Arm II, Arm JJ |
| Investigational Influenza and COVID-19 Combination VaccineInvestigational Combined Influenza and COVID-19 Vaccine | Combination product | Arm AA, Arm BB, Arm CC, Arm D, Arm DD, Arm E, Arm EE, Arm F, Arm G, Arm J, Arm K, Arm KK, Arm L, Arm LL, Arm MM, Arm NN, Arm OO |
| Licensed Influenza Vaccine 1Licensed Influenza Vaccine 1 | Biological | Arm I |
| Licensed Influenza Vaccine 2Licensed Influenza Vaccine 2 | Biological | Arm HH, Arm N |
| Licensed Influenza Vaccine 3Licensed Influenza Vaccine 3 | Biological | Arm GG, Arm SS |
| Licensed COVID-19 VaccinePfizer-BioNTech COVID-19 Vaccine | Biological | Arm FF, Arm H, Arm M, Arm RR |
Primary outcome
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Time frame: Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Time frame: Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Time frame: 1 month
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
Time frame: 6 months
1 secondary outcome
GMTs before and through 1 month following investigational product administration
Time frame: Before vaccination through to 1 month after 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 Jan 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pfizer CT.gov Call Center study director
Pfizer
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Investigational Influenza Vaccine, Investigational COVID-19 Vaccine and Investigational Influenza and COVID-19 Combination Vaccine in people with Influenza and COVID-19 (Coronavirus Disease 2019), run by BioNTech SE at 31 sites in United States.
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 2 inclusion and 4 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration (time frame: Day 7). 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 Jan 2026.