Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193215
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media (AOM) Biological: V114 Other: Pediatric vaccines Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
Estimated Study Start Date : June 17, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: V114
Participants will receive an intramuscular (IM) injection.
Biological: V114
IM injection

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

Control Other: Pediatric vaccines
Standard of care vaccines administered according to the local recommended schedule.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   42 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193215


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04193215    
Other Study ID Numbers: V114-032
V114-032 ( Other Identifier: Merck )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs