Acute Otitis Media (AOM) Clinical Trial
Official title:
A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
| Verified date | February 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 7000 |
| Est. completion date | June 5, 2025 |
| Est. primary completion date | June 5, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 42 Days to 90 Days |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Chulalongkorn University ( Site 0008) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Phramongkutklao Hospital ( Site 0003) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Siriraj Hospital ( Site 0004) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Maharaj Nakorn Chiang Mai Hospital ( Site 0001) | Chiang Mai | |
| Thailand | Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015) | Chiang Rai | |
| Thailand | Prince of Songkla University Faculty of Medicine ( Site 0005) | Hat Yai | Songkhla |
| Thailand | Srinagarind Hospital ( Site 0002) | Khon Kaen | |
| Thailand | Faculty of Medicine Thammasat Univ. ( Site 0007) | Khong Luang | Pathum Thani |
| Thailand | Bamrasnaradura Infectious Disease Institute ( Site 0011) | Nonthaburi | |
| Thailand | Panyananthaphikkhu Chonprathan Medical Center ( Site 0014) | Pak Kret | Nonthaburi |
| Thailand | Ramathibodi Hospital, Mahidol University ( Site 0009) | Rajthevee | Krung Thep Maha Nakhon |
| Thailand | Bhumibol Adulyadej Hospital ( Site 0013) | Sai Mai | Krung Thep Maha Nakhon |
| Thailand | Sappasit Prasong Hosptial-Pediatric ( Site 0016) | Ubon Ratchathani |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to ~36 months | |
| Primary | 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. | Up to ~36 months | |
| Primary | 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. | Up to ~36 months | |
| Primary | 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. | Up to ~36 months | |
| Primary | Percentage of Participants Who Died | The percentage of participants who died from any cause during the study will be assessed. | Up to ~36 months |