Pneumonia, PneumococcalPhase 3NCT05526716
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
A Phase 3 study testing V116 and QIV in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 56 sites in United States.
Trial summary
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- V116 and QIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,080 participants
- Where
- 56 sitesUnited States
- Study dates
- 23 Sep 2022to 21 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
- Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
Who cannot join
- History of IPD or other culture-positive pneumococcal disease
- Known or suspected impairment of immunological function
- Receipt of systemic corticosteroids or immunosuppressive therapy
- Received any pneumococcal vaccine <12 months prior to enrollment
- Prior administration of PCV15 or PCV20
- Received any influenza vaccine <6 months prior to enrollment
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
Velocity Clinical Research, Anderson ( Site 0077)
Anderson, South Carolina, 29621
Optimal Research ( Site 0015)
Austin, Texas, 78705
Holston Medical Group-Clinical Research ( Site 0028)
Bristol, Tennessee, 37620
Headlands Research - Brownsville ( Site 0069)
Brownsville, Texas, 78526
Hope Clinical Research, Inc. ( Site 0070)
Canoga Park, California, 91303
East Coast Institute for Research - Canton ( Site 0004)
Canton, Georgia, 30114
Synexus Clinical Research US, Inc. ( Site 0072)
Chicago, Illinois, 60602
CTI Clinical Research Center ( Site 0071)
Cincinnati, Ohio, 45212
Velocity Clinical Research, Columbia ( Site 0058)
Columbia, South Carolina, 29204
Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
Cortland, New York, 13045
Velocity Clinical Research, Providence ( Site 0021)
East Greenwich, Rhode Island, 02818
Centennial Medical Group ( Site 0035)
Elkridge, Maryland, 21075
Carolina Institute for Clinical Research ( Site 0047)
Fayetteville, North Carolina, 28303
Healthcare Research Network - Chicago ( Site 0014)
Flossmoor, Illinois, 60422
Benchmark Research ( Site 0025)
Fort Worth, Texas, 76135
Velocity Clinical Research, Hallandale Beach ( Site 0064)
Hallandale, Florida, 33009
Hatboro Medical Associates / CCT Research ( Site 0065)
Hatboro, Pennsylvania, 19040
Indago Research & Health Center, Inc ( Site 0029)
Hialeah, Florida, 33012
New Horizon Medical Group ( Site 0078)
Houston, Texas, 77042
Innovative Medical Research of Texas ( Site 0079)
Houston, Texas, 77065
East Coast Institute for Research, LLC ( Site 0013)
Jacksonville, Florida, 32216
Health Awareness ( Site 0034)
Jupiter, Florida, 33458
Holston Medical Group-Clinical Research ( Site 0009)
Kingsport, Tennessee, 37660
Paradigm Clinical Research Centers, Inc ( Site 0024)
La Mesa, California, 91942
WR-CRCN, LLC ( Site 0018)
Las Vegas, Nevada, 89106
Alivation Research-Primary Care ( Site 0066)
Lincoln, Nebraska, 68526
Velocity Clinical Research, Medford ( Site 0060)
Medford, Oregon, 97504
Optimal Research ( Site 0008)
Melbourne, Florida, 32934
Suncoast Research Group-Clinical Department ( Site 0062)
Miami, Florida, 33135
Suncoast Research Associates ( Site 0041)
Miami, Florida, 33173
Alpha Science Research ( Site 0042)
Miami, Florida, 33186
Lakes Research ( Site 0063)
Miami Lakes, Florida, 33014
Catalina Research Institute, LLC ( Site 0067)
Montclair, California, 91763
Synexus Clinical Research US, Inc. ( Site 0001)
Murray, Utah, 84123
Clinical Research Associates Inc ( Site 0026)
Nashville, Tennessee, 37203
Synexus Clinical Research US, Inc - New York ( Site 0053)
New York, New York, 10017
WR- PRI, LLC ( Site 0044)
Newport Beach, California, 92620
Carbon Health - North Hollywood - NoHo West ( Site 0016)
North Hollywood, California, 91606
Valley Clinical Trials, Inc. ( Site 0002)
Northridge, California, 91325
LinQ Research ( Site 0074)
Pearland, Texas, 77584
Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)
Phoenix, Arizona, 85020
M3 Wake Research Associates ( Site 0040)
Raleigh, North Carolina, 27612
Rochester Clinical Research, Inc. ( Site 0055)
Rochester, New York, 14609
Artemis Institute for Clinical Research ( Site 0023)
San Diego, California, 92103
WR-MCCR, LLC ( Site 0033)
San Diego, California, 92120
California Research Foundation ( Site 0005)
San Diego, California, 92123
Axces Research ( Site 0037)
Santa Fe, New Mexico, 87505
Alliance for Multispecialty Research, LLC ( Site 0051)
South Jordan, Utah, 84095
Arthritis Northwest, PLLC ( Site 0059)
Spokane, Washington, 99204
Velocity Clinical Research, Spokane ( Site 0050)
Spokane, Washington, 99204
Healthcare Research Network - St. Louis ( Site 0011)
St Louis, Missouri, 63042
Radiant Research ( Site 0073)
St Louis, Missouri, 63141
Clinical Research Atlanta ( Site 0068)
Stockbridge, Georgia, 30281
Meridian Clinical Research, LLC ( Site 0032)
Vestal, New York, 13850
Diablo Clinical Research, Inc. ( Site 0020)
Walnut Creek, California, 94598
Triple O Research Institute, P.A ( Site 0054)
West Palm Beach, Florida, 33407
About this study
Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- V116, QIV, Matching Placebo for V116
- Medical subject headings
- Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V116Biological
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
QIVBiological
Single 0.5 mL IM injection
Matching Placebo for V116Biological
Single 0.5 mL of sterile saline IM injection
| Study group | Role | What they receive |
|---|---|---|
| Concomitant group (V116 + QIV followed by placebo) | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30 Receives: Biological: V116; Biological: QIV; Biological: Matching Placebo for V116 |
| Sequential group (placebo + QIV followed by V116) | Experimental | Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30 Receives: Biological: V116; Biological: QIV; Biological: Matching Placebo for V116 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling.
Measured: Up to 5 days post-vaccination
Number of Participants With Solicited Systemic AEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.
Measured: Up to 5 days post-vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.
Measured: Up to ~6 months postvaccination with V116
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.
Measured: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.
Measured: Day 30
Secondary outcomes (5)
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay.
Measured: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA
OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Measured: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
GMFR Ratio of Serotype-specific IgG
GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL.
Measured: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
GMFR in Influenza Strain-specific HAI
Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.
Measured: Day 1 (Baseline) and Day 30 (Postvaccination)
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40
The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start23 Sep 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
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 Pneumonia, PneumococcalStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526716
- Sponsor's protocol ID
- V116-005
- Status last verified
- Oct 2025
- First submitted
- 31 Aug 2022
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Omole T, Weinberg AS, Azizad M, Greenberg D, Grijalva CG, Orenstein WA, Euler D, Fernsler D, Park J, Li J, Platt HL; STRIDE-5 study group. A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Vaccine. 2025 Aug 30;62:127514. doi: 10.1016/j.vaccine.2025.127514. Epub 2025 Jul 25.
PubMed 40714528
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
- ClinicalTrials.gov ID
- NCT05526716
- Acronym / sponsor ID
- V116-005
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant group (V116 + QIV followed by placebo) | Experimental | Biological: V116, Biological: QIV, Biological: Matching Placebo for V116Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30 |
| Sequential group (placebo + QIV followed by V116) | Experimental | Biological: V116, Biological: QIV, Biological: Matching Placebo for V116Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
- Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
Key exclusion criteria (6 listed)
- History of IPD or other culture-positive pneumococcal disease
- Known or suspected impairment of immunological function
- Receipt of systemic corticosteroids or immunosuppressive therapy
- Received any pneumococcal vaccine <12 months prior to enrollment
- Prior administration of PCV15 or PCV20
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 |
|---|---|---|
| V116Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution | Biological | Concomitant group (V116 + QIV followed by placebo), Sequential group (placebo + QIV followed by V116) |
| QIVSingle 0.5 mL IM injection | Biological | Concomitant group (V116 + QIV followed by placebo), Sequential group (placebo + QIV followed by V116) |
| Matching Placebo for V116Single 0.5 mL of sterile saline IM injection | Biological | Concomitant group (V116 + QIV followed by placebo), Sequential group (placebo + QIV followed by V116) |
Primary outcome
Number of Participants With Solicited Injection-site Adverse Events (AEs)
Time frame: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling.
Number of Participants With Solicited Systemic AEs
Time frame: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Time frame: Up to ~6 months postvaccination with V116
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
Time frame: Day 30
GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.
5 secondary outcomes
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA
Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
GMFR Ratio of Serotype-specific IgG
Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
GMFR in Influenza Strain-specific HAI
Time frame: Day 1 (Baseline) and Day 30 (Postvaccination)
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40714528Omole T, Weinberg AS, Azizad M, Greenberg D, Grijalva CG, Orenstein WA, Euler D, Fernsler D, Park J, Li J, Platt HL; STRIDE-5 study group. A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Vaccine. 2025 Aug 30;62:127514. doi: 10.1016/j.vaccine.2025.127514. Epub 2025 Jul 25.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V116 and QIV in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 56 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 6 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 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Injection-site Adverse Events (AEs) (time frame: Up to 5 days post-vaccination). The study lists 5 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 NCT05526716, 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 29 Oct 2025.