Back to resultsV114 and Acute Otitis Media (V114-032/PNEU-ERA)
Primary Purpose
Acute Otitis Media (AOM)
Status
Recruiting
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
V114
Pediatric vaccines
Sponsored by
About this trial
This is an interventional prevention trial for Acute Otitis Media (AOM)
Eligibility 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.
Sites / Locations
- Chulalongkorn University ( Site 0008)Recruiting
- Phramongkutklao Hospital ( Site 0003)
- Siriraj Hospital ( Site 0004)Recruiting
- Ramathibodi Hospital, Mahidol University ( Site 0009)Recruiting
- Bhumibol Adulyadej Hospital ( Site 0013)Recruiting
- Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)Recruiting
- Faculty of Medicine Thammasat Univ. ( Site 0007)Recruiting
- Prince of Songkla University Faculty of Medicine ( Site 0005)Recruiting
- Maharaj Nakorn Chiang Mai Hospital ( Site 0001)Recruiting
- Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)Recruiting
- Srinagarind Hospital ( Site 0002)Recruiting
- Bamrasnaradura Infectious Disease Institute ( Site 0011)Recruiting
- Sappasit Prasong Hosptial-Pediatric ( Site 0016)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
V114
Control
Arm Description
Participants will receive an intramuscular (IM) injection.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Percentage of Participants Who Died
The percentage of participants who died from any cause during the study will be assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04193215
First Posted
December 9, 2019
Last Updated
October 3, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04193215
Brief Title
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
Official Title
A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
December 16, 2026 (Anticipated)
Study Completion Date
December 16, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media (AOM)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V114
Arm Type
Experimental
Arm Description
Participants will receive an intramuscular (IM) injection.
Arm Title
Control
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
IM injection
Intervention Type
Other
Intervention Name(s)
Pediatric vaccines
Intervention Description
Standard of care vaccines administered according to the local recommended schedule.
Primary Outcome Measure Information:
Title
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
Description
The number of participants with VT-AOM will be presented.
Time Frame
Up to ~36 months
Title
Percentage of Participants with Serious Adverse Events
Description
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
Title
Percentage of Participants with Vaccine-Related Serious Adverse Events
Description
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
Title
Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
Description
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
Title
Percentage of Participants Who Died
Description
The percentage of participants who died from any cause during the study will be assessed.
Time Frame
Up to ~36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Chulalongkorn University ( Site 0008)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6622564930
Facility Name
Phramongkutklao Hospital ( Site 0003)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Siriraj Hospital ( Site 0004)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6624195671
Facility Name
Ramathibodi Hospital, Mahidol University ( Site 0009)
City
Rajthevee
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6682-205-7515
Facility Name
Bhumibol Adulyadej Hospital ( Site 0013)
City
Sai Mai
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10220
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+662 534 7307
Facility Name
Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)
City
Pak Kret
State/Province
Nonthaburi
ZIP/Postal Code
11120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
66818595238
Facility Name
Faculty of Medicine Thammasat Univ. ( Site 0007)
City
Khong Luang
State/Province
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+66896671860
Facility Name
Prince of Songkla University Faculty of Medicine ( Site 0005)
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6674451271
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 0001)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6653 9360 46-49
Facility Name
Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
053910600, 2101
Facility Name
Srinagarind Hospital ( Site 0002)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+66897112236
Facility Name
Bamrasnaradura Infectious Disease Institute ( Site 0011)
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
66820160123
Facility Name
Sappasit Prasong Hosptial-Pediatric ( Site 0016)
City
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6645319200
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://merckclinicaltrials.com
Description
Merck Clinical Trials Information
Learn more about this trial
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
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