NCT04193215 - V114 and Acute Otitis Media (V114-032/PNEU-ERA) | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

7,119

Conditions

Acute Otitis Media (AOM)

Interventions

V114BIOLOGICAL

IM injection

Pediatric vaccinesOTHER

Standard of care vaccines administered according to the local recommended schedule.

Eligibility

Sex: ALLMin age: 42 DaysMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (13)

Chulalongkorn University ( Site 0008)

Bangkok, Bangkok, Thailand

Phramongkutklao Hospital ( Site 0003)

Bangkok, Bangkok, Thailand

Siriraj Hospital ( Site 0004)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to ~36 months

Percentage of Participants Who Died

The percentage of participants who died from any cause during the study will be assessed.

Time frame: Up to ~36 months