Effect of Prevnar 13 on Ear Infections in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01199016
First received: September 8, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Otitis Media
Procedure: Tympanocentesis
Procedure: Nose/throat swab
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Observational Study of the Effectiveness of Pneumococcal 13-valent Conjugate Vaccine (13vPnC) in Reducing Acute Otitis Media and Nasopharyngeal Colonization in Young Children Caused by Serotypes in the Vaccine.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated from middle ear fluid from children with acute otitis media. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated the respiratory tract of children enrolled in this study. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Streptococcus Pneumoniae serotypes not included in Prevnar 13 and other bacterial pathogens isolated from the middle ear fluid from children with acute otitis media. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Streptococcus Pneumoniae serotypes not included in Prevnar 13 and other bacterial pathogens isolated from the respiratory tract of children enrolled in this study. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis


Estimated Enrollment: 360
Study Start Date: September 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: Tympanocentesis
To be performed as needed on children presenting with acute otitis media
Procedure: Nose/throat swab
To be performed at every study visit

Detailed Description:

Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy children aged approximately 6 to 36 months of age.

Criteria

Inclusion Criteria:

  • Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria:

  • Prior vaccination with any 7vPnC.
  • Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199016

Locations
United States, New York
Penfield Pediatrics
Penfield, New York, United States, 14526
Westfall Pediatrics
Rochester, New York, United States, 14618
Sunrise Pediatrics
Rochester, New York, United States, 14618
Lewis Pediatrics
Rochester, New York, United States, 14618
Pathway Pediatrics
Rochester, New York, United States, 14618
Legacy Pediatrics
Rochester, New York, United States, 14618
Long Pond Pediatrics
Rochester, New York, United States, 14606
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01199016     History of Changes
Other Study ID Numbers: 6096A1-4010, B1851018
Study First Received: September 8, 2010
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Acute otitis media
Prevnar 13
Streptococcus pneumoniae
nasopharyngeal colonization.

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014