Trial Outcomes & Findings for Effect of Prevnar 13 on Ear Infections in Children (NCT NCT01199016)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

239 participants

Primary outcome timeframe

Baseline up to Month 36

Results posted on

2017-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	239
Overall Study Treated	236
Overall Study COMPLETED	162
Overall Study NOT COMPLETED	77

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study No longer meets eligibility criteria	4
Overall Study Entrance criteria	5
Overall Study Protocol Violation	9
Overall Study Other	13
Overall Study Withdrawal by Subject	21
Overall Study Lost to Follow-up	25

Baseline Characteristics

Effect of Prevnar 13 on Ear Infections in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevnar 13 n=236 Participants 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).
Age, Continuous	7.4 months STANDARD_DEVIATION 2.61 • n=5 Participants
Gender Female	115 Participants n=5 Participants
Gender Male	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Prevnar 13 n=53 MEF Samples 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).
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Prevnar 13 n=383 NP/OP Samples 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).
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Prevnar 13 n=53 MEF Samples 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).
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Prevnar 13 n=383 NP/OP Samples 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).
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

Adverse Events

Prevnar 13

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER