Streptococcus Pneumoniae InfectionsNCT00952367
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
An observational study of Streptococcus Pneumoniae Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infections
- What is being tested?
- Nasopharyngeal swab
- How many people
- 3,641 participants
- Where
- 6 sitesChina
- Study dates
- Apr 2009to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy Children 12 to 18 months old
Who may be able to join
- Healthy children aged 12-18 months
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Pfizer Investigational Site
Beijing, Beijing Municipality, 10013
Pfizer Investigational Site
Dongguan, Guangdong, 523016
Pfizer Investigational Site
Jinan, Shandong, 250001
Pfizer Investigational Site
Nanjing, Jiangsu, 210003
Pfizer Investigational Site
Shanghai, Shanghai Municipality, 200336
Pfizer Investigational Site
Wuhan, Hubei, 430015
About this study
Official title: Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
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.
- Conditions
- Streptococcus Pneumoniae Infections
- Being tested
- Nasopharyngeal swab
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabOther
Nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
Measured: Day 1
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.
Measured: Day 1
Secondary outcomes (8)
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.
Measured: Day 1
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.
Measured: Day 1
Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.
Measured: Day 1
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Categories are types of antibiotics.
Measured: Day 1
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Categories are types of antibiotics.
Measured: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).
Measured: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).
Measured: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Streptococcus Pneumoniae InfectionsStudies 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
- 3,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952367
- Sponsor's protocol ID
- 0887X1-4602
- Status last verified
- Mar 2012
- First submitted
- 3 Aug 2009
- Last updated
- 23 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
- ClinicalTrials.gov ID
- NCT00952367
- Acronym / sponsor ID
- 0887X1-4602
- Conditions
- Streptococcus Pneumoniae Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,641 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 23 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per-protocol population | – | Other: Nasopharyngeal swabIn 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. |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Children 12 to 18 months old
Key inclusion criteria (1 listed)
- Healthy children aged 12-18 months
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabNasopharyngeal swab | Other | Per-protocol population |
Primary outcome
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Time frame: Day 1
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
Time frame: Day 1
Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.
8 secondary outcomes
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Time frame: Day 1
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Time frame: Day 1
Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Time frame: Day 1
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Time frame: Day 1
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Time frame: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Time frame: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Time frame: Day 1
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Streptococcus Pneumoniae Infections
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites 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 1 inclusion and 7 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae (time frame: Day 1). The study lists 2 primary outcomes in all. 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 23 Apr 2012.