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?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000743662

Enrollment

316

Registered

2014-07-14

Start date

2011-04-19

Completion date

2014-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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-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

Eligibility

Sex/Gender

All

Age

1 Years to 19 Years

Healthy volunteers

Inclusion criteria

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 criteria

Previously enrolled Cystic fibrosis Immunodeficiency Interstitial lung disease

Outcome results