Effect of Prevnar 13 on Ear Infections in Children
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01199016
First received: September 8, 2010
Last updated: April 12, 2013
Last verified: April 2013
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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 ]
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: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (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 30 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy children aged approximately 6 to <30 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199016
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, New York | |
| Legacy Pediatrics | Recruiting |
| Rochester, New York, United States, 14618 | |
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: | April 12, 2013 |
| 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 May 16, 2013