Pneumococcal DiseaseNCT00471770
Pneumoniae Epidemiology Study in China
An observational study of Pneumococcal Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages Up to 60 months
- Conditions the study is for
- Pneumococcal Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2007to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 months
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
Who may be able to join
- Age, 60 months or less
- Meets study criteria for clinical pneumonia
- All the examination are/can be done within (before or after) 72 hours to enrollment time
- Informed consent obtained from parent or guardian
Who cannot join
- Received any pneumococcal vaccine in the past
- Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
- Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
- Children with recurrent pneumonia will enter into the study on only one occasion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Study of Hospitalized Pediatric Pneumonia in China
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).
Read the detailed 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.
- Conditions
- Pneumococcal Disease
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 1.Core group: enrolled subjects who have isolated pneumococcal | |
| 2 | 2.SPN group:enrolled subjects who have no isolated pneumococcal | |
| 3 | 3.DCF group: Subjects screened but not enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471770
- Sponsor's protocol ID
- 0887X-101894
- Status last verified
- Mar 2008
- First submitted
- 8 May 2007
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Hospitalized Pediatric Pneumonia in China
- ClinicalTrials.gov ID
- NCT00471770
- Acronym / sponsor ID
- 0887X-101894
- Conditions
- Pneumococcal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –1.Core group: enrolled subjects who have isolated pneumococcal |
| 2 | – | –2.SPN group:enrolled subjects who have no isolated pneumococcal |
| 3 | – | –3.DCF group: Subjects screened but not enrolled |
Who may qualify
- Ages
- Up to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children with pneumoniae less than 5 years,located in Tianjin Children's Hospital
Key inclusion criteria (4 listed)
- Age, 60 months or less
- Meets study criteria for clinical pneumonia
- All the examination are/can be done within (before or after) 72 hours to enrollment time
- Informed consent obtained from parent or guardian
Key exclusion criteria (4 listed)
- Received any pneumococcal vaccine in the past
- Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
- Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
- Children with recurrent pneumonia will enter into the study on only one occasion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
Related trials for Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
Active, not recruitingPhase 1
A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
Pneumococcal Disease
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2008; AzTrials last refreshed its copy on 31 Oct 2026.