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

Wyeth

Status: Completed

Conditions: Streptococcus Pneumoniae Infections

Treatments: Other: Nasopharyngeal swab

Study type: Observational

Funder types: Industry

Identifiers

NCT00952367

0887X1-4602

Details and patient eligibility

About

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.

Enrollment: 3,641 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3,641 participants in 1 patient group

Per-protocol population

Description:

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.

Treatment:

Other: Nasopharyngeal swab