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

NCT00952367 | Completed Results

• 1 other identifier: 0887X1-4602
• Study Type: observational
• Target: 3,641
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Streptococcus Pneumoniae Infections

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (8)

• Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B

  Day 1

• Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis

  Day 1

• Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics

  Day 1

• Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics

  Day 1

• Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics

  Day 1

Study Arms (1)

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.

Other: Nasopharyngeal swab

Interventions

Nasopharyngeal swab OTHER

Nasopharyngeal swab

Per-protocol population

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Children 12 to 18 months old

You may qualify if:

• Healthy children aged 12-18 months

You may not qualify if:

• Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible
• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (6)

Pfizer Investigational Site

Beijing, Beijing Municipality, 10013, China

Location

Pfizer Investigational Site

Dongguan, Guangdong, 523016, China

Location

Pfizer Investigational Site

Wuhan, Hubei, 430015, China

Location

Pfizer Investigational Site

Nanjing, Jiangsu, 210003, China

Location

Pfizer Investigational Site

Jinan, Shandong, 250001, China

Location

Pfizer Investigational Site

Shanghai, Shanghai Municipality, 200336, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swab

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 23, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-03

Locations

CN (6)