You are here

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

Last updated on January 24, 2020

FOR MORE INFORMATION
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.
Show details

- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasopharyngeal swab
Sampling Method Non-Probability Sample
Study Population Healthy Children 12 to 18 months old
Condition Streptococcus Pneumoniae Infections
Intervention Other: Nasopharyngeal swab
Nasopharyngeal swab
Study Groups/Cohorts 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
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2012)
3641
Original Estimated Enrollment
 (submitted: August 3, 2009)
3600
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Months to 18 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00952367
Other Study ID Numbers 0887X1-4602
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now