Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488371
Status:
COMPLETED
Last Update Posted:
2007-12-20
First Post:
2007-06-18
Brief Title:
Study Evaluating Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Prevnar
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 5000 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 199 overall for children 1-14 years and 271 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
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 199 overall for children 1-14 years and 271 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None