Clinical trial NCT01272999: Impact of Prevnar 13 on Ear Infections in Children
Official title: POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Mastoiditis
Keywords: Acute otitis media
Prevnar 13
Streptococcus pneumoniae
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 391
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6 weeks to 18 years

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1
timeFrame: Surveillance Year 1
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2
timeFrame: Surveillance Year 2
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3
timeFrame: Surveillance Year 3
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1
timeFrame: Surveillance Year 1
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 2
timeFrame: Surveillance Year 2
measure: Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 3
timeFrame: Surveillance Year 3
Secondary outcomes:
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population
timeFrame: Surveillance Year 1, 2, 3
measure: Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population
timeFrame: Surveillance Year 1, 2, 3
measure: Percentage of Participants With Primary Clinical Diagnosis of Otitis Media
timeFrame: Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
measure: Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis
timeFrame: Surveillance Year 1, 2, 3
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles - University of Southern California School of Medicine
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Chicago
country: United States
facility: Children's Memorial Hospital- Feinberg School Medicine, Northwestern University
state: Illinois
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital - Wake Forest University School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital - Ohio State University of Medicine and Public Health
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: