N/A
Completed N=391
Impact of Prevnar 13 on Ear Infections in Children
Source: ClinicalTrials.gov NCT01272999 ↗Enrolled (actual)
391
Serious AEs
—
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1 — 5.9; 0.7; 31.9; 2.2 percentage of isolates
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1 |
5.9; 0.7; 31.9; 2.2; 40.7; 6.7 | — |
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2 |
6.3; 0.0; 23.4; 1.8; 31.5; 4.5 | — |
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3 |
7.2; 0.0; 9.9; 6.3; 23.4; 1.8 | — |
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1 |
0.0; 0.0; 0.0; 0.0; 38.9; 11.1 | — |
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 2 |
0.0; 28.6; 0.0; 0.0; 71.4; 0.0 | — |
| PRIMARY Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 3 |
0.0; 44.4; 0.0; 0.0; 11.1; 11.1 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population |
3.0; 3.0; 0.0; 0.7; 1.5; 1.5 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population |
1.5; 2.2; 0.7; 0.0; 0.7; 0.0 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population |
5.9; 6.7; 1.5; 2.2; 3.0; 3.7 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population |
4.4; 0.0; 1.5; 1.5; 0.7; 0.0 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population |
5.9; 4.4; 1.5; 2.2; 3.0; 3.0 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population |
5.2; 1.5; 2.2; 3.0; 3.7; 0.0 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population |
3.0; 0.7; 1.5; 1.5; 0.7; 2.2 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population |
0.0; 5.6; 5.6; 5.6; 0.0; 27.8 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population |
0.0; 0.0; 5.6; 0.0; 0.0; 5.6 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population |
0.0; 5.6; 0.0; 5.6; 0.0; 5.6 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population |
0.0; 5.6; 0.0; 5.6; 0.0; 5.6 | — |
| SECONDARY Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Primary Clinical Diagnosis of Otitis Media |
24.0; 45.3; 30.7; 37.8; 31.1; 31.1 | — |
| SECONDARY Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis |
52.9; 20.6; 26.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01272999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.