No intervention
OtherNon interventional
NCT Number: NCT01272999
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.
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Notify Me0 year and older
All sexes
Observational
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non interventional
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pfizer
Industry
POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN
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