Pneumoniae Epidemiology Study in China

Status Completed

Clinical Trial Summary

To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

Clinical Trial Description

Subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology of the lower respiratory tract infection. Clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. The chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. Bacterial isolates other than Streptococcus pneumoniae will be identified according to standardized procedures. S. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. Serotype will be determined using type-specific sera (Quellung reaction). Antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, Amoxycillin, Ofloxacin, Vancomycin, and imipenem be conducted using E-test according to standardized procedures at the central facilities. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Pneumococcal Disease

Clinical Trial Details

NCT number	NCT00471770
Study type	Observational
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	N/A
Start date	February 2007
Completion date	February 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04546425` - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants	Phase 3
Recruiting	`NCT06044077` - A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People	Phase 3
Completed	`NCT02146365` - Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
Completed	`NCT04525599` - A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator	Phase 1
Active, not recruiting	`NCT05512819` - A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan	Phase 3
Completed	`NCT04530838` - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants	Phase 3
Active, not recruiting	`NCT06026748` - A Phase I Study of XJ103 in Chinese Healthy Subjects	Phase 1
Completed	`NCT04526574` - Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age	Phase 3
Completed	`NCT05329259` - A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India	Phase 4
Completed	`NCT00234338` - Study Evaluating Prevenar in High-Risk Children	N/A
Completed	`NCT01767402` - Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults	Phase 1
Active, not recruiting	`NCT05569954` - Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)	Phase 3
Completed	`NCT01111214` - Child Pneumococcal Serotype Epidemiology In Greece	N/A
Completed	`NCT01298544` - A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers	Phase 4
Completed	`NCT04830358` - Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults	Phase 1
Completed	`NCT04379713` - 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants	Phase 3
Completed	`NCT04887948` - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2	Phase 3
Completed	`NCT04382326` - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants	Phase 3
Not yet recruiting	`NCT00843895` - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years	N/A
Completed	`NCT01734239` - A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)	Phase 3