Trials / Completed
CompletedNCT01199016
Effect of Prevnar 13 on Ear Infections in Children
"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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 239 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Months – 30 Months
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2010-09-10
- Last updated
- 2017-03-01
- Results posted
- 2017-03-01
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01199016. Inclusion in this directory is not an endorsement.