Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

Streptococcus Pneumoniae Infections Clinical Trial

Official title:

Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952367
• Other study ID #: 0887X1-4602
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: March 12, 2012
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3641
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

Inclusion Criteria

• Healthy children aged 12-18 months

Exclusion Criteria

• 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumococcal Infections
• Pneumonia
• Streptococcus Pneumoniae Infections

Intervention

Other:
• Nasopharyngeal swab
Nasopharyngeal swab

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Beijing	Beijing
China	Pfizer Investigational Site	Dongguan	Guangdong
China	Pfizer Investigational Site	Jinan	Shandong
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Shanghai	Shanghai
China	Pfizer Investigational Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Primary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics	Categories are types of antibiotics.	Day 1	No
Secondary	Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics	Categories are types of antibiotics.	Day 1	No
Secondary	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).	Day 1	No
Secondary	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).	Day 1	No
Secondary	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).	Day 1	No

External Links

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