Otitis Media
Conditions
Keywords
Acute otitis media, Prevnar 13, Streptococcus pneumoniae, nasopharyngeal colonization.
Brief 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.
Interventions
PROCEDURETympanocentesis
To be performed as needed on children presenting with acute otitis media
PROCEDURENose/throat swab
To be performed at every study visit
BIOLOGICALObservational
Observational Study Only
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 30 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants | 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) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevnar 13 Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (\>=)3 distinct episodes in a 6-month period or \>=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed). | 236 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Entrance criteria | 5 |
| Overall Study | Lost to Follow-up | 25 |
| Overall Study | No longer meets eligibility criteria | 4 |
| Overall Study | Other | 13 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Prevnar 13 |
|---|---|
| Age, Continuous | 7.4 months STANDARD_DEVIATION 2.61 |
| Gender Female | 115 Participants |
| Gender Male | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 239 |
| serious Total, serious adverse events | 0 / 239 |
Outcome results
Primary
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)
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.
Time frame: Baseline up to Month 36
Population: MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevnar 13 | 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) | 7.5 percentage of MEF samples |
Other Pre-specified
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)
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.
Time frame: Baseline up to Month 36
Population: MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevnar 13 | 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) | 92.5 percentage of MEF samples |
Other Pre-specified
Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants
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.
Time frame: Baseline up to Month 36
Population: NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevnar 13 | Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants | 6.0 percentage of NP/OP samples |
Other Pre-specified
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
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.
Time frame: Baseline up to Month 36
Population: NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevnar 13 | 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 | 94.0 percentage of NP/OP samples |