Clinical trial NCT01199016: Effect of Prevnar 13 on Ear Infections in Children
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Keywords: Acute otitis media
Prevnar 13
Streptococcus pneumoniae
nasopharyngeal colonization.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 239
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children aged approximately 6 to 36 months of age.

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.

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Baseline up to Month 36
Secondary outcomes:
Other outcomes:
measure: Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants
timeFrame: Baseline up to Month 36
measure: 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)
timeFrame: Baseline up to Month 36
measure: 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
timeFrame: Baseline up to Month 36
Locations:
city: Penfield
country: United States
facility: Penfield Pediatrics
state: New York
city: Rochester
country: United States
facility: Long Pond Pediatrics
state: New York
city: Rochester
country: United States
facility: Legacy Pediatrics
state: New York
city: Rochester
country: United States
facility: Lewis Pediatrics
state: New York
city: Rochester
country: United States
facility: Pathway Pediatrics
state: New York
city: Rochester
country: United States
facility: Sunrise Pediatrics
state: New York
city: Rochester
country: United States
facility: Westfall Pediatrics
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.