Study Evaluating Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Prevnar®

NCT00488371

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-5 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy children aged 2 to 5 years old identified by the Taipei City government and are participating in Taipei City's PCV7 vaccination program.

- Informed consent obtained from parents or legal guardian.

- Eligible to receive 1 dose of PCV7

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


- Children with any of the following conditions: immunologic diseases; neoplastic
disorders; renal, cardiac, hepatic, or hematologic diseases; bronchodysplasia; Down
syndrome; chronic otitis media with effusion.


- Children with any acute illness including mild acute respiratory infection or fever >
38 centigrade.

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Prevnar®
Official Title Evaluation of Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Pneumococcal Conjugated Vaccine (Prevnar®) Under the Auspices of the Taipei City Government Vaccination Program
Brief Summary

Primary Objective:

To evaluate the impact of PCV7 vaccination on NP carriage rate of vaccine serotypes and serotype distribution

Secondary Objective:

To evaluate the impact of PCV7 vaccination on NP carriage of antibiotic resistant pneumococci and serotype distribution.

Detailed Description

Under the Social Welfare Vaccination Program, the Taipei City Government will vaccinate approximately 5,000 children residing in the city of Taipei between 2 and 5 years of age during the months of November 2006 to April 2007 with one dose of PCV7.

To gather baseline data on serotype distribution and antibiotic resistance of nasopharyngeal (NP) carriage isolates in this population and measure vaccine impact on NP carriage, the Taipei city government requires the evaluation of the vaccination program through the detection of Streptococcus pneumoniae NP carriage rate pre and post vaccination in a convenience sample of approximately 1000 children. This number complies with the Taipei city government request for the inclusion of 250 children.

Streptococcus pneumoniae is a major cause of bacterial otitis media, pneumonia, sepsis, bacteraemia, and meningitis among infants worldwide.

The main reservoir of pneumococci is the human nasopharynx. The mean age of first acquisition is 6 months and carriage rates peak in the preschool age group. The organisms have pilli on their surface to assist in adhering to nasopharyngeal mucosal receptors. Streptococcus pneumoniae is part of the normal flora in colonized individuals, but the organism has the ability to cause disease by invading neighboring tissues, and potentially spreading into the bloodstream and other sites, causing invasive pneumococcal disease, such as bacteremia, sepsis and meningitis. The rate of NP carriage for Streptococcus pneumoniae in Taiwan (1998-99) was estimated to be 19.9 % overall for children 1-14 years and 27.1 % for those 2-5 years. A more recent study by Lauderdale et al. found a carriage rate of 41 % in children attending a kindergarten program in Taiwan where a 5 year old was diagnosed with streptococcus meningitis.

Prevnar® has shown a high degree of efficacy in the prevention of invasive pneumococcal disease in children. In addition, PCV7 has been shown to decrease NP carriage of serotypes included in the vaccine (VST). Since NP carriage is a prerequisite for transmission of Streptococcus pneumoniae, decrease in NP carriage of VSTs in children has resulted in decreased transmission to their contacts and an indirect effect (herd effect) on invasive pneumococcal disease. Since the majority of antibiotic resistant strains are VST, PCV7 immunization has decreased antibiotic resistance in invasive pneumococcal disease for both those immunized and their contacts. However, after PCV7 vaccination overall pneumococcal NP carriage rates do not change, since Streptococcus pneumoniae serotypes not included in the vaccine (NVST) replace the VSTs. Although in the nasopharynx there is an almost complete replacement by NVST, these serotypes may have less ability to cause invasive disease, since disease with NVST has been observed but to a much lower magnitude than disease prior to PCV7 vaccination.

Thus, the expected outcome of a successful PCV7 vaccination program on NP carriage is a decrease in carriage of VST with an increase in NVST and thus, a stable overall Streptococcus pneumoniae carriage rate.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Pneumococcal Infections
Intervention Biological: Pneumococcal Conjugated Vaccine (Prevnar®)
Study Groups/Cohorts Not Provided
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
Enrollment
 (submitted: June 19, 2007)
250
Original Enrollment Same as current
Actual Study Completion Date April 2007
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion criteria

  • Healthy children aged 2 to 5 years old identified by the Taipei City government and are participating in Taipei City's PCV7 vaccination program.
  • Informed consent obtained from parents or legal guardian.
  • Eligible to receive 1 dose of PCV7

Exclusion criteria

  • Children with any of the following conditions: immunologic diseases; neoplastic disorders; renal, cardiac, hepatic, or hematologic diseases; bronchodysplasia; Down syndrome; chronic otitis media with effusion.
  • Children with any acute illness including mild acute respiratory infection or fever > 38 centigrade.
Sex/Gender
Sexes Eligible for Study:All
Ages 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00488371
Other Study ID Numbers 0887X1-4410
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007