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Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

Last updated on April 10, 2018

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Study Location
Pfizer Investigational Site
Beijing, Beijing, 10013 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Streptococcus Pneumoniae Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-18 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy children aged 12-18 months

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00952367
Pfizer
Completed
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

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Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Nasopharyngeal swab
Non-Probability Sample
Healthy Children 12 to 18 months old
Streptococcus Pneumoniae Infections
Other: Nasopharyngeal swab
Nasopharyngeal swab
Per-protocol population
In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
Intervention: Other: Nasopharyngeal swab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3641
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months to 18 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00952367
0887X1-4602
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2012

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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