NCT01199016|CompletedResults

Effect of Prevnar 13 on Ear Infections in Children

"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

Pfizer ClinicalTrials.gov

Compare

2 other identifiers

6096A1-4010B1851018

Study Type

observational

Target

239

Locations

1 country

Sites

Timeline

RegisteredSep 2010

StartedSep 2010

CompletionJan 2016

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

239

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.3 years study duration

Study Start

First participant enrolled

September 1, 2010

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 1, 2017

Completed

Last Updated

March 1, 2017

Status Verified

December 1, 2016

Enrollment Period

5.3 years

First QC Date

September 8, 2010

Results QC Date

January 10, 2017

Last Update Submit

January 10, 2017

Conditions

Otitis Media

Keywords

Acute otitis mediaPrevnar 13Streptococcus pneumoniaenasopharyngeal colonization.

Outcome Measures

Primary Outcomes (1)

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.
Baseline up to Month 36

Other Outcomes (3)

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
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
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

Study Arms (1)

1

Procedure: TympanocentesisProcedure: Nose/throat swabBiological: Observational

Interventions

TympanocentesisPROCEDURE

To be performed as needed on children presenting with acute otitis media

Nose/throat swabPROCEDURE

To be performed at every study visit

ObservationalBIOLOGICAL

Observational Study Only

Eligibility Criteria

Age6 Months - 30 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Healthy children aged approximately 6 to 36 months of age.

You may qualify if:

Subject has received full (3-dose) infant series of Prevnar 13

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (7)

Penfield Pediatrics

Penfield, New York, 14526, United States

Location

Long Pond Pediatrics

Rochester, New York, 14606, United States

Location

Legacy Pediatrics