Impact of Prevnar 13 on Ear Infections in Children

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Acute Otitis Media; Mastoiditis

Study Design

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Study Type :	Observational
Actual Enrollment :	391 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children
Study Start Date :	December 2010
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1; Otitis media cases

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ]
2. S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ]
3. S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ]

Secondary Outcome Measures :

1. The antimicrobial susceptibility patterns for each isolate [ Time Frame: Study Completion (36 months from study start) ]
2. The primary clinical diagnosis of each child from whom S pneumoniae is isolated [ Time Frame: Study Completion (36 months from study start) ]

Biospecimen Retention:   None Retained

Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	6 Weeks to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children aged 6 weeks to 18 years

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Children's Hospital of Los Angeles - University of Southern California School of Medicine
Los Angeles, California, United States, 90027
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, North Carolina
Brenner Children's Hospital - Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Nationwide Children's Hospital - Ohio State University of Medicine and Public Health
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Children's Hospital - Feigin Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01272999 History of Changes
Other Study ID Numbers:	6096A1-4024; B1851040
First Posted:	January 10, 2011
Last Update Posted:	September 12, 2014
Last Verified:	September 2014

Keywords provided by Pfizer:

Acute otitis media; Prevnar 13; Streptococcus pneumoniae

Additional relevant MeSH terms:

Otitis; Otitis Media; Mastoiditis; Ear Diseases; Otorhinolaryngologic Diseases; Osteomyelitis; Bone Diseases, Infectious	Infection; Bone Diseases; Musculoskeletal Diseases; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs