Impact of Prevnar 13 on Ear Infections in Children

Acute Otitis Media Clinical Trial

Official title:

POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272999
• Other study ID #: 6096A1-4024
• Secondary ID: B18510402014-001
• Status: Completed
• Start date: May 21, 2010
• Est. completion date: December 19, 2013

Study information

• Verified date: October 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: December 19, 2013
• Est. primary completion date: December 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Mastoiditis
• Otitis
• Otitis Media

Intervention

Other:
• No intervention
Non interventional

Locations

Country	Name	City	State
United States	Children's Memorial Hospital- Feinberg School Medicine, Northwestern University	Chicago	Illinois
United States	Nationwide Children's Hospital - Ohio State University of Medicine and Public Health	Columbus	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital of Los Angeles - University of Southern California School of Medicine	Los Angeles	California
United States	Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rady Children's Hospital	San Diego	California
United States	Brenner Children's Hospital - Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at 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
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at 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
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at 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
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at 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
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at 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
Primary	Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at 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	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population	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
Secondary	Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population	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
Secondary	Percentage of Participants With Primary Clinical Diagnosis of Otitis Media	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.	Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
Secondary	Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis	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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