Acute Otitis MediaNCT01272999

Impact of Prevnar 13 on Ear Infections in Children

An observational study of Acute Otitis Media and Mastoiditis, run by Pfizer at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: Acute Otitis Media, Mastoiditis
How many people: 391 participants
Where: 8 sitesUnited States
Study dates: 21 May 2010to 19 Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Children aged 6 weeks to 18 years

Who may be able to join

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.

Who cannot join

As this is an observational, laboratory based database study, there are no exclusion criteria

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Children's Memorial Hospital- Feinberg School Medicine, Northwestern University
Chicago, Illinois, 60614
Nationwide Children's Hospital - Ohio State University of Medicine and Public Health
Columbus, Ohio, 43205
Texas Children's Hospital
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital of Los Angeles - University of Southern California School of Medicine
Los Angeles, California, 90027
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Rady Children's Hospital
San Diego, California, 92123
Brenner Children's Hospital - Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN

Conditions: Acute Otitis Media, Mastoiditis
Being tested: No intervention
Keywords: Acute otitis media, Prevnar 13, Streptococcus pneumoniae
Medical subject headings: Otitis Media, Mastoiditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
Non interventional

Study groups in NCT01272999
Study group	Role	What they receive
1		Otitis media cases Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 1 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95 percent (%) confidence interval (CI) based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this outcome measure (OM).
Measured: Surveillance Year 1
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 2 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 2
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 3 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 3
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 1 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 2
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 2 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 2
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 3
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 3 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 3

Secondary outcomes (14)

Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for amoxicillin from MEF samples was categorized as resistant, susceptible or intermediate based on minimum inhibitory concentration (MIC) for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for cefotaxime from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for ceftriaxone from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for clindamycin from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for erythromycin from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19A, 19F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for penicillin from MEF samples were summarized by providing the range of MICs for penicillin tested and the percentage of the susceptibility interpretation was categorized as resistant, susceptible or intermediate for each serotype, and for each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19 A, 19 F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95 % CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population
Antimicrobial susceptibility of S pneumoniae isolates for TMP/S from MEF samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 19A, 19F, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38, clumps and missing or non-viable, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population
Antimicrobial susceptibility of S pneumoniae isolates for ceftriaxone from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. 'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population
Antimicrobial susceptibility of S pneumoniae isolates for clindamycin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. 'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population
Antimicrobial susceptibility of S pneumoniae isolates for erythromycin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. 'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population
Antimicrobial susceptibility of S pneumoniae isolates for penicillin from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. 'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population
Antimicrobial susceptibility of S pneumoniae isolates for TMP/S from mastoid samples was categorized as resistant, susceptible or intermediate based on MIC for each serotype at each year of the whole surveillance period. The percentage of S pneumoniae serotypes included 3, 12, 15A, 15B, 15F, 19A, 19F, 21, 22F, 23A, 38, which were to be computed along with exact 2-sided 95% CI based on the observed proportion of isolates. 'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Measured: Surveillance Year 1, 2, 3
Percentage of Participants With Primary Clinical Diagnosis of Otitis Media
Percentage of participants with primary diagnosis of otitis media was computed along with exact 2-sided 95% CI based on the observed proportion of participants for each of the 3 surveillance year. Results for baseline period were analyzed for participants who received routinely recommended vaccination of 13vPnC. The cases of otitis media reported during the baseline period were captured by the Texas Children's Hospital, which was the only site that collected this information during the baseline period. Percentage of participants was calculated by dividing number of participants with at least 1 MEF sample for the specified year by total number of participants with at least 1 MEF sample for the 3 year surveillance period.
Measured: Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis
Percentage of participants with primary diagnosis of mastoiditis was computed along with exact 2-sided 95% CI based on the observed proportion of participants for each of the 3 surveillance year. Percentage of participants was calculated by dividing number of participants with at least 1 mastoid sample for the specified year by total number of participants with at least 1 mastoid sample for the 3 year surveillance period.
Measured: Surveillance Year 1, 2, 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 May 201019 Dec 2013

First posted10 Jan 2011 (estimated)
Study start21 May 2010
Primary completion19 Dec 2013
Study completion19 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 391 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272999
Sponsor's protocol ID: 6096A1-4024
Other IDs: B1851040, 2014-001174-34, 2014
Status last verified: Oct 2020
First submitted: 8 Dec 2010
Last updated: 23 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Acute Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: POSTMARKETING OBSERVATIONAL STUDY OF THE IMPACT OF PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) ON OTITIS MEDIA IN CHILDREN
ClinicalTrials.gov ID: NCT01272999
Acronym / sponsor ID: 6096A1-4024
Conditions: Acute Otitis Media, Mastoiditis
Keywords: Acute otitis media, Prevnar 13, Streptococcus pneumoniae
Study type: Observational
Recruitment status: Completed
Enrolment: 391 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 21 May 2010 (actual)
Primary completion: 19 Dec 2013 (actual)
Study completion: 19 Dec 2013 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 10 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Other: No interventionOtitis media cases

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Children aged 6 weeks to 18 years

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

As this is an observational, laboratory based database study, there are no exclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNon interventional	Other	1

Primary outcome

Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1
Time frame: Surveillance Year 1
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 1 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95 percent (%) confidence interval (CI) based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this outcome measure (OM).
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2
Time frame: Surveillance Year 2
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 2 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3
Time frame: Surveillance Year 3
The distribution of S pneumoniae serotypes isolated from MEF samples from children in the target population for vaccination over the surveillance year 3 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (3, 7F, 19A, 19F) and not included in Prevnar 13 (6C, 7C, 9N, 10, 11, 12, 12F, 13, 15A, 15B, 15C, 15F, 16, 17, 20, 21, 22F, 23A, 23B, 31, 33A, 33F, 34, 35B, 35F, 38) along with total (both included and not included), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1
Time frame: Surveillance Year 1
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 1 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 2
Time frame: Surveillance Year 2
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 2 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.
Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 3
Time frame: Surveillance Year 3
The distribution of S pneumoniae serotypes isolated from mastoiditis samples from children in the target population for vaccination over the surveillance year 3 were presented. The percentage of isolates of S pneumoniae serotypes included in Prevnar 13 (1, 3, 7F, 14, 19A, 19F) and not included in Prevnar 13 (6C, 12, 15A, 15B, 15F, 21, 22F, 23A, 33F, 35B, 38) along with total (both included and not included in Prevnar 13 ), clumps and missing or non-viable were computed along with exact 2-sided 95% CI based on the observed proportion of isolates. Missing or non-viable included isolates that were either not sent from an external laboratory, were non-viable or lost on culture prior to sending, or were non-viable on receipt in the central laboratory.'Number of isolates analyzed' signifies total number of isolates that were evaluable for this OM.

14 secondary outcomes

Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Amoxicillin: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Cefotaxime: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Middle Ear Fluid (MEF) Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Ceftriaxone: Mastoid Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Clindamycin: Mastoid Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Erythromycin: Mastoid Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Penicillin: Mastoid Population
Time frame: Surveillance Year 1, 2, 3
Antimicrobial Susceptibility of Streptococcus Pneumoniae Isolates for Trimethoprim/Sulfamethoxazole (TMP/S): Mastoid Population
Time frame: Surveillance Year 1, 2, 3
Percentage of Participants With Primary Clinical Diagnosis of Otitis Media
Time frame: Baseline Year 1, 2, 3; Surveillance Year 1, 2, 3
Percentage of Participants With Primary Clinical Diagnosis of Mastoiditis
Time frame: Surveillance Year 1, 2, 3

Results and safety

Results posted to the registry on 10 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MEF Population	357	357
Mastoid Population	34	34

Primary outcome: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1

Time frame: Surveillance Year 1. Number (95% Confidence Interval). Unit: percentage of isolates

Measure	MEF Population n = 357
Serotype included in Prevnar 13:3	5.9 (2.6 to 11.3)
Serotype included in Prevnar 13:7F	0.7 (0.0 to 4.1)
Serotype included in Prevnar 13:19A	31.9 (24.1 to 40.4)
Serotype included in Prevnar 13:19F	2.2 (0.5 to 6.4)
Total Serotype included in Prevnar 13	40.7 (32.4 to 49.5)
Serotype not included in Prevnar 13:6C	6.7 (3.1 to 12.3)
Serotype not included in Prevnar 13:7C	1.5 (0.2 to 5.2)
Serotype not included in Prevnar 13:9N	2.2 (0.5 to 6.4)

Population analysed: MEF population included all participants who have at least 1 S pneumoniae isolate from MEF samples. N (number of participants analyzed) includes total number of participants in MEF population, however actual 'N' for this OM is unknown as this data were not calculated as per planned analysis.

Primary outcome: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 2

Time frame: Surveillance Year 2. Number (95% Confidence Interval). Unit: percentage of isolates

Measure	MEF Population n = 357
Serotype included in Prevnar 13:3	6.3 (2.6 to 12.6)
Serotype included in Prevnar 13:7F	0.0 (0.0 to 3.3)
Serotype included in Prevnar 13:19A	23.4 (15.9 to 32.4)
Serotype included in Prevnar 13:19F	1.8 (0.2 to 6.4)
Total Serotype included in Prevnar 13	31.5 (23.0 to 41.0)
Serotype not included in Prevnar 13:6C	4.5 (1.5 to 10.2)
Serotype not included in Prevnar 13:7C	0.9 (0.0 to 4.9)
Serotype not included in Prevnar 13:9N	0.0 (0.0 to 3.3)

Primary outcome: Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 3

Time frame: Surveillance Year 3. Number (95% Confidence Interval). Unit: percentage of isolates

Measure	MEF Population n = 357
Serotype included in Prevnar 13:3	7.2 (3.2 to 13.7)
Serotype included in Prevnar 13:7F	0.0 (0.0 to 3.3)
Serotype included in Prevnar 13:19A	9.9 (5.1 to 17.0)
Serotype included in Prevnar 13:19F	6.3 (2.6 to 12.6)
Total Serotype included in Prevnar 13	23.4 (15.9 to 32.4)
Serotype not included in Prevnar 13:6C	1.8 (0.2 to 6.4)
Serotype not included in Prevnar 13:7C	0.0 (0.0 to 3.3)
Serotype not included in Prevnar 13:9N	0.9 (0.0 to 4.9)

Primary outcome: Percentage of Streptococcus Pneumoniae Serotype Isolates From Mastoiditis Sample at Surveillance Year 1

Time frame: Surveillance Year 1. Number (95% Confidence Interval). Unit: percentage of isolates

Measure	Mastoid Population n = 34
Serotype included in Prevnar 13:1	0.0 (0.0 to 18.5)
Serotype included in Prevnar 13:3	0.0 (0.0 to 18.5)
Serotype included in Prevnar 13:7F	0.0 (0.0 to 18.5)
Serotype included in Prevnar 13:14	0.0 (0.0 to 18.5)
Serotype included in Prevnar 13:19A	38.9 (17.3 to 64.3)
Serotype included in Prevnar 13:19F	11.1 (1.4 to 34.7)
Total Serotype included in Prevnar 13	50.0 (26.0 to 74.0)
Serotype not included in Prevnar 13:6C	5.6 (0.1 to 27.3)

Population analysed: Mastoid population included all participants who have at least 1 S pneumoniae isolate from mastoid samples. N (number of participants analyzed) includes total number of participants in mastoid population, however actual 'N' for this OM is unknown as this data were not calculated as per planned analysis.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MEF Population	0 of 0	0 of 0	Not reported
Mastoid Population	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Otitis Media and Mastoiditis, run by Pfizer at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Streptococcus Pneumoniae Serotype Isolates From Middle Ear Fluid (MEF) Sample at Surveillance Year 1 (time frame: Surveillance Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.