Acute Otitis Media (AOM)Phase 3NCT04193215
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
A Phase 3 study testing V114 and Pediatric vaccines in people with Acute Otitis Media (AOM), run by Merck Sharp & Dohme LLC at 13 sites in Thailand.
Trial summary
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. Read more about this study
- Who is it for?
- Ages 42 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media (AOM)
- What is being tested?
- V114 and Pediatric vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,119 participants
- Where
- 13 sitesThailand
- Study dates
- 12 Sep 2020to 22 Dec 2025
- Phase
- Phase 3
- 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 42 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Is healthy (based on a review of medical history and physical examination)
- Is male or female, approximately 2 months of age, from 42 days to 90 days of age
Who cannot join
- Was born prior to 37 weeks of gestation.
- Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
- Has any contraindication to the concomitant study vaccines being administered in the study.
- Has external auditory canal atresia/stenosis.
- Has a known or suspected impairment of immunological function.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Thailand13 sites
Chulalongkorn University ( Site 0008)
Bangkok, Bangkok, 10330
Phramongkutklao Hospital ( Site 0003)
Bangkok, Bangkok, 10400
Siriraj Hospital ( Site 0004)
Bangkok, Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital ( Site 0001)
Chiang Mai, 50200
Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)
Chiang Rai, 57000
Prince of Songkla University Faculty of Medicine ( Site 0005)
Hat Yai, Changwat Songkhla, 90110
Srinagarind Hospital ( Site 0002)
Khon Kaen, 40002
Faculty of Medicine Thammasat Univ. ( Site 0007)
Khong Luang, Changwat Pathum Thani, 12120
Bamrasnaradura Infectious Disease Institute ( Site 0011)
Nonthaburi, 11000
Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)
Pak Kret, Changwat Nonthaburi, 11120
Ramathibodi Hospital, Mahidol University ( Site 0009)
Rajthevee, Bangkok, 10400
Bhumibol Adulyadej Hospital ( Site 0013)
Sai Mai, Bangkok, 10220
Sappasit Prasong Hosptial-Pediatric ( Site 0016)
Ubon Ratchathani, 34000
About this study
Official title: A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
- Conditions
- Acute Otitis Media (AOM)
- Being tested
- V114, Pediatric vaccines
- Medical subject headings
- Otitis Media
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
IM injection
Pediatric vaccinesOther
Standard of care vaccines administered according to the local recommended schedule.
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | Participants will receive an intramuscular (IM) injection. Receives: Biological: V114; Other: Pediatric vaccines |
| Control | Other | Not described Receives: Other: Pediatric vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
The number of participants with VT-AOM will be presented.
Measured: Up to ~36 months
Percentage of Participants with Serious Adverse Events
A serious adverse event (SAE) is an AE that results in death, 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.
Measured: Up to ~36 months
Percentage of Participants with Vaccine-Related Serious Adverse Events
A serious adverse event (SAE) is an AE that results in death, 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.
Measured: Up to ~36 months
Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
A serious adverse event (SAE) is an AE that results in death, 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.
Measured: Up to ~36 months
Percentage of Participants Who Died
The percentage of participants who died from any cause during the study will be assessed.
Measured: Up to ~36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start12 Sep 2020
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis Media (AOM)Studies 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
- 7,119 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
- NCT04193215
- Sponsor's protocol ID
- V114-032
- Other IDs
- V114-032, 2023-001146-11, 2023
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2019
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
- ClinicalTrials.gov ID
- NCT04193215
- Acronym / sponsor ID
- V114-032
- Conditions
- Acute Otitis Media (AOM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,119 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 10 Dec 2019 (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 primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
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: V114, Other: Pediatric vaccinesParticipants will receive an intramuscular (IM) injection. |
| Control | Other | Other: Pediatric vaccines |
Who may qualify
- Ages
- 42 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Is healthy (based on a review of medical history and physical examination)
- Is male or female, approximately 2 months of age, from 42 days to 90 days of age
Key exclusion criteria (6 listed)
- Was born prior to 37 weeks of gestation.
- Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
- Has any contraindication to the concomitant study vaccines being administered in the study.
- Has external auditory canal atresia/stenosis.
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 VaccineIM injection | Biological | V114 |
| Pediatric vaccinesStandard of care vaccines administered according to the local recommended schedule. | Other | Control, V114 |
Primary outcome
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
Time frame: Up to ~36 months
The number of participants with VT-AOM will be presented.
Percentage of Participants with Serious Adverse Events
Time frame: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, 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.
Percentage of Participants with Vaccine-Related Serious Adverse Events
Time frame: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, 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.
Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
Time frame: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, 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.
Percentage of Participants Who Died
Time frame: Up to ~36 months
The percentage of participants who died from any cause during the study will be assessed.
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 22 Jan 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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
13 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 Pediatric vaccines in people with Acute Otitis Media (AOM), run by Merck Sharp & Dohme LLC at 13 sites in Thailand.
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 22 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 13 sites in Thailand. 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?
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?
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114 (time frame: Up to ~36 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?
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 22 Jan 2026.