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Effect of Prevnar 13 on Ear Infections in Children
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01199016
First received: September 8, 2010
Last updated: January 10, 2017
Last verified: December 2016
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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 Biological: Observational | Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | "a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM) [ Time Frame: Baseline up to Month 36 ]MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
Other Outcome Measures:
- Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants [ Time Frame: Baseline up to Month 36 ]Total percentage of NP/OP samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
- Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM) [ Time Frame: Baseline up to Month 36 ]MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
- Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants [ Time Frame: Baseline up to Month 36 ]Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
Biospecimen Retention: Samples Without DNA
Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis
| Enrollment: | 239 |
| Study Start Date: | September 2010 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 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
Biological: Observational
Observational Study Only
|
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: | 6 Months to 30 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199016
Locations
| United States, New York | |
| Penfield Pediatrics | |
| Penfield, New York, United States, 14526 | |
| Long Pond Pediatrics | |
| Rochester, New York, United States, 14606 | |
| Legacy Pediatrics | |
| Rochester, New York, United States, 14618 | |
| Lewis Pediatrics | |
| Rochester, New York, United States, 14618 | |
| Pathway Pediatrics | |
| Rochester, New York, United States, 14618 | |
| Sunrise Pediatrics | |
| Rochester, New York, United States, 14618 | |
| Westfall Pediatrics | |
| Rochester, New York, United States, 14618 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01199016 History of Changes |
| Other Study ID Numbers: |
6096A1-4010 B1851018 ( Other Identifier: Alias Study Number ) |
| Study First Received: | September 8, 2010 |
| Results First Received: | January 10, 2017 |
| Last Updated: | January 10, 2017 |
Keywords provided by Pfizer:
|
Acute otitis media Prevnar 13 Streptococcus pneumoniae nasopharyngeal colonization. |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017