Clinical trial NCT00952367: Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Official title: Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus Pneumoniae Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 3641
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Children 12 to 18 months old

Brief summary: This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.


Eligibility criteria: Inclusion Criteria

* Healthy children aged 12-18 months

Exclusion Criteria

* Use of antibiotics up to 15 days prior to study inclusion
* Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible
* Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion.
* Received any pneumococcal vaccine in the past.
* Children who have already provided a NP sample in the same study period.
* Any relevant hemorrhagic disorder.
* Any febrile process (fever ≥ 38°C) at time of screening.

Primary outcomes:
measure: Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
timeFrame: Day 1
measure: Percentage of Participants With Serotypes of Streptococcus Pneumoniae
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
timeFrame: Day 1
measure: Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
timeFrame: Day 1
measure: Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
timeFrame: Day 1
measure: Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
timeFrame: Day 1
measure: Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
timeFrame: Day 1
measure: Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
timeFrame: Day 1
measure: Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
timeFrame: Day 1
measure: Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
timeFrame: Day 1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Dongguan
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Jinan
country: China
facility: Pfizer Investigational Site
state: Shandong
city: Shanghai
country: China
facility: Pfizer Investigational Site
state: Shanghai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: