RecruitingACTRN12614000743662

A cohort study to examine the effect of 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix, Registered Trademark) on the frequency of non-typeable Haemophilus influenzae (NTHi) infection in the upper and lower airways of children

Does prior immunization with PHiD-CV influence the frequency of NTHi detection in the upper and lower airways in children undergoing bronchoscopy?


Sponsor

Menzies School of Health Research, Charles Darwin University

Enrollment

316 participants

Start Date

Apr 19, 2011

Study Type

Observational

Conditions

Summary

The aims of our study are to: 1. Determine the frequency of NTHi infection (defined by >10E4 cfu/ml BAL) in the lower airways of children who have received PHiD-CV; 2. Determine the frequency of NTHi carriage in the upper airways of children who have received PHiD-CV; and 3. Evaluate the influence of PHiD-CV on the systemic adaptive immunity to NTHi in`children with chronic suppurative lung disease.


Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 19 Yearss

Inclusion Criteria2

  • Subjects: Children undergoing bronchoscopy who have had at least one PHiD-CV dose more than a month before bronchoscopy
  • Comparator: Children undergoing bronchoscopy who have not had any PHiD-CV dose (Brisbane and/or Darwin)

Exclusion Criteria4

  • Previously enrolled
  • Cystic fibrosis
  • Immunodeficiency
  • Interstitial lung disease

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Interventions

PHiD-CV given as per the Northern Territory infant immunization schedule. Child is not observed for any set period of time. Observation consist of the bronchoscopy alveolar lavage results at the time-

PHiD-CV given as per the Northern Territory infant immunization schedule. Child is not observed for any set period of time. Observation consist of the bronchoscopy alveolar lavage results at the time-point when the procedure is undertaken for clinical purposes and not for research purposes. Thus there is no time limit of the observation period as the bronchoscopy is undertaken when the paediatrician (not related to the study) deemed the procedure is necessary


Locations(2)

Royal Darwin Hospital - Tiwi

NT,QLD, Australia

Royal Children's Hospital - Herston

NT,QLD, Australia

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ACTRN12614000743662