Acute Otitis Media (AOM)
Conditions
Brief 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. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
Interventions
BIOLOGICALV114
IM injection
OTHERPediatric vaccines
Standard of care vaccines administered according to the local recommended schedule.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 90 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114 | Up to ~36 months | The number of participants with VT-AOM will be presented. |
| Percentage of Participants with Serious Adverse Events | 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 | 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 | 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 | Up to ~36 months | The percentage of participants who died from any cause during the study will be assessed. |
Countries
Thailand
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed