V114 and Acute Otitis Media (V114-032/PNEU-ERA)

Study Overview
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Brief Summary
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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.

Official Title
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A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)

Conditions
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Acute Otitis Media (AOM)

Intervention / Treatment
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* Biological: V114
* Other: Pediatric vaccines


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V114<br>Participants will receive an intramuscular (IM) injection. | Biological: V114<br>* IM injection<br>* Other names: Pneumococcal 15-Valent Conjugate Vaccine;Other: Pediatric vaccines<br>* Standard of care vaccines administered according to the local recommended schedule.<br>|
| Other: Control<br> | Other: Pediatric vaccines<br>* Standard of care vaccines administered according to the local recommended schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of Participants Who Died | The percentage of participants who died from any cause during the study will be assessed. | Up to  36 months |