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Completed

NCT Number: NCT00952367

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

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Key information

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasopharyngeal Swab

Other

Nasopharyngeal swab

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B

    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 Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.

  2. Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis

    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 Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.

  3. Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics

    Time frame: Day 1

    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.

  4. Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics

    Time frame: Day 1

    Categories are types of antibiotics.

  5. Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics

    Time frame: Day 1

    Categories are types of antibiotics.

  6. Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae

    Time frame: Day 1

    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).

  7. Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B

    Time frame: Day 1

    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).

  8. Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis

    Time frame: Day 1

    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).

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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