Pneumococcal InfectionsPhase 3NCT04384107
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
A Phase 3 study testing V114 and PCV13 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 45 sites in Japan.
Trial summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- V114 and PCV13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 45 sitesJapan
- Study dates
- 1 Jul 2020to 1 Dec 2021
- 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 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Japanese male or female
Who cannot join
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
- Has a known or suspected impairment of immunological function
- Has a history of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- Has or his/her mother has a documented hepatitis B surface antigen-positive test
Show all 11Show fewer
- Has known or history of functional or anatomic asplenia
- Has a history of autoimmune disease
- Has a known neurologic or cognitive behavioral disorder
- Has received a dose of any pneumococcal vaccine prior to study entry
- Has received a blood transfusion or blood products, including immunoglobulins
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Japan45 sites
Kobayashi Pediatric Clinic ( Site 3301)
Fujieda, Shizuoka, 426-0067
Fukui Aiiku Hospital ( Site 3315)
Fukui, 910-0833
Fukui-ken Saiseikai Hospital ( Site 3314)
Fukui, 918-8503
Shindo Children's Clinic ( Site 3325)
Fukuoka, 814-0121
Kurokawa Michiko Pediatric Clinic ( Site 3319)
Fukuoka, 815-0033
Shimomura Pediatrics Clinic ( Site 3320)
Fukuoka, 819-0002
INAMITSU Children's Clinic ( Site 3321)
Fukuoka, 819-0041
Kyoritsu Narashinodai Hospital ( Site 3332)
Funabashi, Chiba, 274-0063
Kagoshima Children's Hospital ( Site 3342)
Hioki, Kagoshima-ken, 899-2503
Ina Central Hospital ( Site 3346)
Ina, Nagano, 396-8555
Sotobo Children's Clinic ( Site 3323)
Isumi, Chiba, 299-4503
Taniguchi Hospital ( Site 3310)
Izumisano, Osaka, 598-0043
Yokoyama Children's Clinic ( Site 3309)
Kasuga, Fukuoka, 816-0801
Morinaga Maternity Clinic ( Site 3345)
Kasugai, Aichi-ken, 486-0836
Aiwa Hospital ( Site 3336)
Kawagoe, Saitama, 350-0001
Saiseikai Kawaguchi General Hospital ( Site 3304)
Kawaguchi, Saitama, 332-8558
Kawasaki Municipal Hospital ( Site 3302)
Kawasaki, Kanagawa, 210-0013
Nagamine Soyokaze Clinic ( Site 3348)
Kumamoto, 862-0920
Chugoku Rosai Hospital ( Site 3340)
Kure, Hiroshima, 737-0193
Aizawa Hospital ( Site 3313)
Matsumoto, Nagano, 390-8510
Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)
Nagano, 388-8004
Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
Nagoya, Aichi-ken, 457-8511
Saiseikai Noe Hospital ( Site 3330)
Osaka, 536-0001
Kubota Children's Clinic ( Site 3334)
Osaka, 544-0033
Sano Kids Clinic ( Site 3341)
Osaka, 553-0001
Aizenbashi Hospital ( Site 3317)
Osaka, 556-0005
Saiseikai Shiga Hospital ( Site 3349)
Rittō, Shiga, 520-3046
National Hospital Organization Sagamihara National Hospital ( Site 3303)
Sagamihara, Kanagawa, 252-0392
Medical corporation Waffle GunGunkids Clinic ( Site 3329)
Sakai, Osaka, 591-8023
National Hospital Organization Sendai Medical Center ( Site 3311)
Sendai, Miyagi, 983-8520
Japanese Red Cross Shizuoka Hospital ( Site 3322)
Shizuoka, 420-0853
Shizuoka City Shimizu Hospital ( Site 3347)
Shizuoka, 424-8636
Suita Municipal Hospital ( Site 3338)
Suita, Osaka, 564-8567
Saiwai Kodomo Clinic ( Site 3331)
Tachikawa, Tokyo, 190-0002
Takatsuki General Hospital ( Site 3318)
Takatsuki, Osaka, 569-1192
Nishida Kodomo Clinic ( Site 3306)
Tama, Tokyo, 206-0025
Hara Children's Clinic ( Site 3339)
Tokorozawa, Saitama, 359-1141
Hosaka Children's Clinic ( Site 3307)
Tokyo, 112-0001
The Fraternity Memorial Hospital ( Site 3333)
Tokyo, 130-8587
Okawa Children & Family Clinic ( Site 3305)
Tokyo, 146-0095
Toyama City Hospital ( Site 3328)
Toyama, 939-8511
National Hospital Organization Mie Chuo Medical Center ( Site 3308)
Tsu, Mie-ken, 514-1101
Tsuchiura Kyodo General Hospital ( Site 3327)
Tsuchiura, Ibaraki, 300-0028
National Hospital Organization Saitama Hospital ( Site 3312)
Wako, Saitama, 351-0102
JOHAS Yokohama Rosai Hospital ( Site 3343)
Yokohama, Kanagawa, 222-0036
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
- Conditions
- Pneumococcal Infections
- Being tested
- V114, PCV13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V114Biological
Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.
PCV13Biological
Also called Prevnar 13™
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. Receives: Biological: V114 |
| Pneumococcal 13-valent Conjugate Vaccine (PCV13) | Active comparator | Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. Receives: Biological: PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Injection-Site Adverse Events
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. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Measured: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Percentage of Participants With Solicited Systemic Adverse Events
An 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. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Measured: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Percentage of Participants With Vaccine-Related Serious Adverse Events
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Measured: ~1 month after Dose 4, up to a total of 14 months
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Measured: 30 Days after Dose 3, up to a total of 11 months
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
Measured: 30 Days after Dose 3, up to a total of 11 months
Secondary outcomes (5)
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.
Measured: 30 days after Dose 3, up to a total of 11 months
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Measured: 30 Days after Dose 4, up to a total of 14 months
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.
Measured: 30 Days after Dose 4, up to a total of 14 months
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Measured: 30 Days after Dose 3, up to a total of 11 months
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Measured: 30 Days after Dose 4, up to a total of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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 InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 694 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
- NCT04384107
- Sponsor's protocol ID
- V114-033
- Other IDs
- V114-033, 205287, 2019-003644-68, 2019
- Status last verified
- Jul 2023
- First submitted
- 11 May 2020
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.
PubMed 37344262
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
- ClinicalTrials.gov ID
- NCT04384107
- Acronym / sponsor ID
- V114-033
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 15 Nov 2022
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 clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V114 | Experimental | Biological: V114Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
| Pneumococcal 13-valent Conjugate Vaccine (PCV13) | Active comparator | Biological: PCV13Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Japanese male or female
Key exclusion criteria (11 listed)
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
- Has a known or suspected impairment of immunological function
- Has a history of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| V114Also: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose. | Biological | V114 |
| PCV13Also: Prevnar 13™13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose. | Biological | Pneumococcal 13-valent Conjugate Vaccine (PCV13) |
Primary outcome
Percentage of Participants With Solicited Injection-Site Adverse Events
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
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. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Percentage of Participants With Solicited Systemic Adverse Events
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
An 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. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Percentage of Participants With Vaccine-Related Serious Adverse Events
Time frame: ~1 month after Dose 4, up to a total of 14 months
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
Time frame: 30 Days after Dose 3, up to a total of 11 months
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
Time frame: 30 Days after Dose 3, up to a total of 11 months
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
5 secondary outcomes
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
Time frame: 30 days after Dose 3, up to a total of 11 months
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
Time frame: 30 Days after Dose 4, up to a total of 14 months
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
Time frame: 30 Days after Dose 4, up to a total of 14 months
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
Time frame: 30 Days after Dose 3, up to a total of 11 months
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
Time frame: 30 Days after Dose 4, up to a total of 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37344262Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.
- 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
45 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 V114 and PCV13 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 45 sites in Japan.
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 1 inclusion and 11 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Japan. 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 15 Nov 2022). 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 Solicited Injection-Site Adverse Events (time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months). 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 NCT04384107, 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 28 Jul 2023.