Otitis MediaNCT01199016
Effect of Prevnar 13 on Ear Infections in Children
An observational study of Otitis Media, run by Pfizer at 7 sites in United States.
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 6 to 30 months
- Conditions the study is for
- Otitis Media
- What is being tested?
- Tympanocentesis, Nose/throat swab and Observational
- Type of treatment
- Surgery or procedure
- How many people
- 239 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2010to Jan 2016
- 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 6 to 30 months
- All sexes
- No healthy volunteers
- Child
Study population: Healthy children aged approximately 6 to 36 months of age.
Who may be able to join
- Subject has received full (3-dose) infant series of Prevnar 13
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Penfield Pediatrics
Penfield, New York, 14526
Long Pond Pediatrics
Rochester, New York, 14606
Legacy Pediatrics
Rochester, New York, 14618
Lewis Pediatrics
Rochester, New York, 14618
Pathway Pediatrics
Rochester, New York, 14618
Sunrise Pediatrics
Rochester, New York, 14618
Westfall Pediatrics
Rochester, New York, 14618
About this study
Official title: "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
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.
Read the 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
- Otitis Media
- Being tested
- Tympanocentesis, Nose/throat swab, Observational
- Keywords
- Acute otitis media, Prevnar 13, Streptococcus pneumoniae, nasopharyngeal colonization.
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TympanocentesisProcedure or surgery
To be performed as needed on children presenting with acute otitis media
Nose/throat swabProcedure or surgery
To be performed at every study visit
ObservationalBiological
Observational Study Only
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: Tympanocentesis; Procedure: Nose/throat swab; Biological: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2016
- Study completionJan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199016
- Sponsor's protocol ID
- 6096A1-4010
- Other IDs
- B1851018
- Status last verified
- Dec 2016
- First submitted
- 8 Sep 2010
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pichichero M, Kaur R, Scott DA, Gruber WC, Trammel J, Almudevar A, Center KJ. Effectiveness of 13-valent pneumococcal conjugate vaccination for protection against acute otitis media caused by Streptococcus pneumoniae in healthy young children: a prospective observational study. Lancet Child Adolesc Health. 2018 Aug;2(8):561-568. doi: 10.1016/S2352-4642(18)30168-8. Epub 2018 Jun 19.
PubMed 30119715
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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
- ClinicalTrials.gov ID
- NCT01199016
- Acronym / sponsor ID
- 6096A1-4010
- Conditions
- Otitis Media
- Keywords
- Acute otitis media, Prevnar 13, Streptococcus pneumoniae, nasopharyngeal colonization.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Tympanocentesis, Procedure: Nose/throat swab, Biological: Observational |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy children aged approximately 6 to 36 months of age.
Key inclusion criteria (1 listed)
- Subject has received full (3-dose) infant series of Prevnar 13
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| TympanocentesisTo be performed as needed on children presenting with acute otitis media | Procedure or surgery | 1 |
| Nose/throat swabTo be performed at every study visit | Procedure or surgery | 1 |
| ObservationalObservational Study Only | Biological | 1 |
Primary outcome
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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30119715Pichichero M, Kaur R, Scott DA, Gruber WC, Trammel J, Almudevar A, Center KJ. Effectiveness of 13-valent pneumococcal conjugate vaccination for protection against acute otitis media caused by Streptococcus pneumoniae in healthy young children: a prospective observational study. Lancet Child Adolesc Health. 2018 Aug;2(8):561-568. doi: 10.1016/S2352-4642(18)30168-8. Epub 2018 Jun 19.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, run by Pfizer at 7 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 1 inclusion and 3 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 1 Mar 2017). 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 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) (time frame: Baseline up to Month 36). 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 NCT01199016, which also lists 1 linked publication.
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 1 Mar 2017.