- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272999
Impact of Prevnar 13 on Ear Infections in Children
May 19, 2023 updated by: Pfizer
POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children.
Prevnar 13 is a new vaccine that is similar to Prevnar.
It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar.
Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
391
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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California
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Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles - University of Southern California School of Medicine
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San Diego, California, United States, 92123
- Rady Children's Hospital
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Illinois
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital- Feinberg School Medicine, Northwestern University
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Brenner Children's Hospital - Wake Forest University School of Medicine
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital - Ohio State University of Medicine and Public Health
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children aged 6 weeks to 18 years
Description
Inclusion Criteria:
- Case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database.
- S pneumoniae identified from middle ear fluid or mastoiditis sample.
- Specimen obtained from children aged up to 18 years.
Exclusion Criteria:
- As this is an observational, laboratory based database study, there are no exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Otitis media cases
|
Non interventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1
Time Frame: Surveillance Year 1
|
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 1 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95 percent (%) confidence interval (CI) based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this outcome measure (OM).
|
Surveillance Year 1
|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2
Time Frame: Surveillance Year 2
|
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 2 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 2
|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3
Time Frame: Surveillance Year 3
|
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 3 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 3
|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1
Time Frame: Surveillance Year 1
|
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 1 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1
|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 2
Time Frame: Surveillance Year 2
|
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 2 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 2
|
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 3
Time Frame: Surveillance Year 3
|
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 3 were presented.
The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for amoxicillin from MEF samples was categorized as resistant, susceptible or intermediate based on minimum inhibitory concentration (MIC) for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for cefotaxime from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for ceftriaxone from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for clindamycin from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for erythromycin from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19A, 19F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for penicillin from MEF samples were summarized by providing the range of MICs for penicillin tested and the percentage of the susceptibility interpretation was categorized as resistant, susceptible or intermediate for each serotype, and for each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95 % CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for TMP/S from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19A, 19F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for ceftriaxone from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for clindamycin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for erythromycin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for penicillin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population
Time Frame: Surveillance Year 1, 2, 3
|
Antimicrobial susceptibility of S pneumoniae isolates for TMP/S from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period.
The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates.
'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
|
Surveillance Year 1, 2, 3
|
Percentage of Participants With Primary Clinical Diagnosis of Otitis Media
Time Frame: Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
|
Percentage of participants with primary diagnosis of otitis media was computed along with exact 2-sided 95% CI based on the observed proportion of participants for each of the 3 surveillance year.
Results for baseline period were analyzed for participants who received routinely recommended vaccination of 13vPnC.
The cases of otitis media reported during the baseline period were captured by the Texas Children's Hospital, which was the only site that collected this information during the baseline period.
Percentage of participants was calculated by dividing number of participants with at least 1 MEF sample for the specified year by total number of participants with at least 1 MEF sample for the 3 year surveillance period.
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Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
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Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis
Time Frame: Surveillance Year 1, 2, 3
|
Percentage of participants with primary diagnosis of mastoiditis was computed along with exact 2-sided 95% CI based on the observed proportion of participants for each of the 3 surveillance year.
Percentage of participants was calculated by dividing number of participants with at least 1 mastoid sample for the specified year by total number of participants with at least 1 mastoid sample for the 3 year surveillance period.
|
Surveillance Year 1, 2, 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2010
Primary Completion (Actual)
December 19, 2013
Study Completion (Actual)
December 19, 2013
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-4024
- B1851040 (Other Identifier: Alias Study Number)
- 2014-001174-34 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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