Pneumococcal VaccinesPhase 2NCT06077656

Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 2 study testing IVT PCV-25 Formulation A, IVT PCV-25 Formulation B and IVT PCV-25 Formulation C in people with Pneumococcal Vaccines, run by Inventprise Inc. at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: IVT PCV-25 Formulation A, IVT PCV-25 Formulation B and IVT PCV-25 Formulation C
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 4 sitesCanada
Study dates: 25 Oct 2023to 24 May 2024
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 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
Participant must provide voluntary written informed consent to participate in the study.
Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.

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.
Adults who have previously been vaccinated against S. pneumoniae.
History of microbiologically confirmed invasive disease caused by S. pneumoniae.
History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
Any abnormal vital sign deemed clinically relevant by the PI.
Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)

Show all 18Show fewer

History of any non-study vaccine administration within 14 days of study vaccine administration.
No planned vaccines until after Day 29 (Visit 3).
Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.
Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).
History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
Recent history (within the past year) or signs of alcohol or substance abuse.
History of major psychiatric disorder.
Female adult participants who are pregnant or breastfeeding.
Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

Inventprise Clinical Site
Halifax, Nova Scotia, B3K 6R8
Inventprise Clinical Site
Saint-Louis, Quebec, G1W 4R4
Inventprise Clinical Site
Truro, Nova Scotia, B2N IL2
Inventprise Clinical Site
Vancouver, British Columbia, V5Z 4H4

Other trials in Canada

About this study

Official title: A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

Read the detailed description

A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.

Conditions: Pneumococcal Vaccines
Being tested: IVT PCV-25 Formulation A, IVT PCV-25 Formulation B, IVT PCV-25 Formulation C, PCV 20

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVT PCV-25 Formulation ABiological
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
IVT PCV-25 Formulation BBiological
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
IVT PCV-25 Formulation CBiological
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
PCV 20Biological
20 valent pneumococcal conjugate vaccine

Study groups in NCT06077656
Study group	Role	What they receive
Group A	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 Receives: Biological: IVT PCV-25 Formulation A
Group B	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1 Receives: Biological: IVT PCV-25 Formulation B
Group C	Experimental	Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1 Receives: Biological: IVT PCV-25 Formulation C
Group D	Active comparator	Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1 Receives: Biological: PCV 20

What is being measured

The primary outcome is the main question the study is designed to answer.

Solicited Local Adverse Events (AEs)
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Measured: 7 days post-vaccination (Day 8)
Solicited Systemic AEs
Number and severity of solicited systemic AEs within 7 days after vaccination by group
Measured: 7 days post-vaccination (Day 8)
Unsolicited AEs
Number and severity of unsolicited AEs within 28 days after vaccination by group
Measured: 28 days post-vaccination (Day 29)
Severe Adverse Events (SAEs)
Number of SAEs within 6 months after vaccination by group
Measured: 6 months post-vaccination (Day 169)

Secondary outcomes (5)

Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group
Measured: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
Geometric Mean Fold Rise in serotype specific IgG GMC's from baseline (D1) to Day 29 after vaccination by group
Measured: 28 days post-vaccination (Day 29)
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Percentage of participants achieving a > 4-fold IgG rise from baseline to Day 29 by treatment group
Measured: 28 days post-vaccination (Day 29)
OPA Geometric Mean Concentration Titer (GMT)
Geometric mean titer of serotype-specific OPA antibodies by group and timepoint
Measured: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Geometric mean fold rise (GMFR) of serotype-specific OPA antibodies from baseline to 28 days post-vaccination by group
Measured: From Baseline (Day 1) to 28 days post-vaccination (Day 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 202324 May 2024

First posted11 Oct 2023
Study start25 Oct 2023
Primary completion24 May 2024
Study completion24 May 2024

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 Pneumococcal VaccinesStudies 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
Model description: Multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25 in which healthy adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06077656
Sponsor's protocol ID: CVIA 105
Status last verified: Feb 2026
First submitted: 5 Oct 2023
Last updated: 17 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Plan to be defined at a later date

Publications

Langley JM, Sadarangani M, Ockenhouse C, Barreto L, Ye L, Tang Y, Breeze JL, Feser J, Hosken NA, Andi-Lolo I, Tasker SA, Halperin SA; Canadian Immunization Research Network. Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials. Vaccine. 2026 Mar 7;75:128236. doi: 10.1016/j.vaccine.2026.128236. Epub 2026 Jan 22.
PubMed 41576705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only

All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults
ClinicalTrials.gov ID: NCT06077656
Acronym / sponsor ID: CVIA 105
Conditions: Pneumococcal Vaccines
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Inventprise Inc.Industry (pharma, biotech, devices)
Collaborators: Canadian Center for Vaccinology, Vaccine Evaluation Center, Canada, PATH
Study start: 25 Oct 2023 (actual)
Primary completion: 24 May 2024 (actual)
Study completion: 24 May 2024 (actual)
First posted: 11 Oct 2023 (actual)
Results: Posted 17 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25 in which healthy adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.

Arm	Type	Receives
Group A	Experimental	Biological: IVT PCV-25 Formulation AParticipants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
Group B	Experimental	Biological: IVT PCV-25 Formulation BParticipants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
Group C	Experimental	Biological: IVT PCV-25 Formulation CParticipants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
Group D	Active comparator	Biological: PCV 20Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
Participant must provide voluntary written informed consent to participate in the study.
Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.

Key exclusion criteria (18 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.
Adults who have previously been vaccinated against S. pneumoniae.
History of microbiologically confirmed invasive disease caused by S. pneumoniae.
History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
Any abnormal vital sign deemed clinically relevant by the PI.

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
IVT PCV-25 Formulation A25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant	Biological	Group A
IVT PCV-25 Formulation B25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant	Biological	Group B
IVT PCV-25 Formulation C25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant	Biological	Group C
PCV 2020 valent pneumococcal conjugate vaccine	Biological	Group D

Primary outcome

Solicited Local Adverse Events (AEs)
Time frame: 7 days post-vaccination (Day 8)
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Solicited Systemic AEs
Time frame: 7 days post-vaccination (Day 8)
Number and severity of solicited systemic AEs within 7 days after vaccination by group
Unsolicited AEs
Time frame: 28 days post-vaccination (Day 29)
Number and severity of unsolicited AEs within 28 days after vaccination by group
Severe Adverse Events (SAEs)
Time frame: 6 months post-vaccination (Day 169)
Number of SAEs within 6 months after vaccination by group

5 secondary outcomes

Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
Time frame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
Time frame: 28 days post-vaccination (Day 29)
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Time frame: 28 days post-vaccination (Day 29)
OPA Geometric Mean Concentration Titer (GMT)
Time frame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Time frame: From Baseline (Day 1) to 28 days post-vaccination (Day 29)

Results and safety

Results posted to the registry on 17 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: IVT PCV-25 Formulation A	40	40
Group B: IVT PCV-25 Formulation B	60	60
Group C: IVT PCV-25 Formulation C	80	80
Group D: PCV-20	40	40

Primary outcome: Solicited Local Adverse Events (AEs)

Time frame: 7 days post-vaccination (Day 8). Number. Unit: events

Measure	Group A: IVT PCV-25 Formulation A n = 40	Group B: IVT PCV-25 Formulation B n = 60	Group C: IVT PCV-25 Formulation C n = 80	Group D: PCV-20 n = 39	Total Subjects Analyzed (Local Solicited AE's) n = 219
Local Solicited AE: Grade 4: Potentially Life Threatening	0	0	0	0	0
Local Solicited AE: Grade 3: Severe	2	0	2	0	4
Local Solicited AE: Grade 2: Moderate	14	20	39	19	92
Local Solicited AE: Grade 1: Mild	16	35	32	14	97
Injection site pain and / or tenderness: Grade 4: Potentially Life Threatening	0	0	0	0	0
Injection site pain and / or tenderness: Grade 3: Severe	2	0	1	0	3
Injection site pain and / or tenderness: Grade 2: Moderate	14	19	40	19	92
Injection site pain and / or tenderness: Grade 1: Mild	16	36	32	14	98

Population analysed: Safety population (One participant was missing the Memory Aid so the denominator for safety outcomes is 219 in this specific safety endpoint)

Primary outcome: Solicited Systemic AEs

Time frame: 7 days post-vaccination (Day 8). Number. Unit: events

Measure	Group A: IVT PCV-25 Formulation A n = 40	Group B: IVT PCV-25 Formulation B n = 60	Group C: IVT PCV-25 Formulation C n = 80	Group D: PCV-20 n = 39	Total Solicited Systemic AEs n = 219
Systemic Solicited AE: Grade 4; Potentially Life Threatening	0	0	0	0	0
Systemic Solicited AE: Grade 3; Severe	2	2	1	0	5
Systemic Solicited AE: Grade 2; Moderate	5	16	28	8	57
Systemic Solicited AE: Grade 1; Mild	14	19	26	11	70
Fever: Grade 4; Potentially Life Threatening	0	0	0	0	0
Fever: Grade 3; Severe	0	0	0	0	0
Fever: Grade 2; Moderate	0	0	0	1	1
Fever: Grade 1; Mild	0	1	2	0	3

Population analysed: Safety population (One participant was missing the Memory Aid so the denominator for safety outcomes is 219)

Primary outcome: Unsolicited AEs

Time frame: 28 days post-vaccination (Day 29). Number. Unit: events

Measure	Group A: IVT PCV-25 Formulation A n = 40	Group B: IVT PCV-25 Formulation B n = 60	Group C: IVT PCV-25 Formulation C n = 80	Group D: PCV-20 n = 40	Total of Unsolicited AE's (28 Days Post Vaccination) n = 220
Unsolicited AEs; Grade 5: Fatal	0	0	0	0	0
Unsolicited AEs; Grade 4: Life-threatening	0	0	0	0	0
Unsolicited AEs; Grade 3: Severe	0	2	2	1	5
Unsolicited AEs; Grade 2: Moderate	17	12	22	22	73
Unsolicited AEs; Grade1: Mild	12	24	18	12	66
Blood and lymphatic system disorders; Grade 5: Fatal	0	0	0	0	0
Blood and lymphatic system disorders; Grade 4: Life-threatening	0	0	0	0	0
Blood and lymphatic system disorders; Grade 3: Severe	0	0	0	0	0

Population analysed: Safety population for whom specific safety endpoint data is available

Primary outcome: Severe Adverse Events (SAEs)

Time frame: 6 months post-vaccination (Day 169). Number. Unit: event

Measure	Group A: IVT PCV-25 Formulation A n = 40	Group B: IVT PCV-25 Formulation B n = 60	Group C: IVT PCV-25 Formulation C n = 80	Group D: PCV-20 n = 40	Total Number of SAE's n = 220
Value	0	0	1	0	1

Population analysed: Safety population for whom specific safety endpoint data is available

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: After receipt of vaccination through Day 169. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: IVT PCV-25 Formulation A	0 of 40 (0%)	17 of 40 (42.5%)	0 of 40
Group B: IVT PCV-25 Formulation B	0 of 60 (0%)	24 of 60 (40%)	0 of 60
Group C: IVT PCV-25 Formulation C	1 of 80 (1.3%)	30 of 80 (37.5%)	0 of 80
Group D: PCV-20	0 of 40 (0%)	16 of 40 (40%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41576705Langley JM, Sadarangani M, Ockenhouse C, Barreto L, Ye L, Tang Y, Breeze JL, Feser J, Hosken NA, Andi-Lolo I, Tasker SA, Halperin SA; Canadian Immunization Research Network. Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials. Vaccine. 2026 Mar 7;75:128236. doi: 10.1016/j.vaccine.2026.128236. Epub 2026 Jan 22.
Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trialsLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Plan to be defined at a later date

Related trials for Pneumococcal Vaccines

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
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Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only

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.

Sybil Tasker, MD, MPH, FIDSA study director

Inventprise Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IVT PCV-25 Formulation A, IVT PCV-25 Formulation B and IVT PCV-25 Formulation C in people with Pneumococcal Vaccines, run by Inventprise Inc. at 4 sites in Canada.

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 4 inclusion and 18 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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 17 Mar 2026). 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?

Solicited Local Adverse Events (AEs) (time frame: 7 days post-vaccination (Day 8)). 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?

On the ClinicalTrials.gov record for NCT06077656, 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 17 Mar 2026.