Otitis Media Infectious Aetiology & Vaccine Impact Study

Prospective descriptive study of the infectious aetiology of otitis media and of nasopharyngeal bacterial flora of children in New Zealand under two different pneumococcal vaccination schedules. Multicentre Trial of under 3 year old children at Starship, Counties Manukau and Canterbury DHB's.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000383965

Acronym

OMIVI (Otitis Media Infectious aetiology & Vaccination Impact)

Enrollment

300

Registered

2011-04-13

Start date

2011-04-29

Completion date

Unknown

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

This study aims to describe infectious agents of rAOM and OME in the middle ear of children with a history of rAOM or OME requiring insertion of tympanostomy tubes. We also aim to describe the nasopharyngeal carriage rates of known otopathogens in children with a history of otitis media. We will run the study as two phases: 300 children who have been vaccinated under the current PCV7 schedule, and to repeat the study after introduction of the PCV10 vaccination (starting collection in 2013)

Interventions

Subjects (300 children <3y undergoing grommet insertion)Collection of Middle Ear Fluid (at time of grommet insertion) Collection of Nasopharyngeal Swab (at time of Grommet insertion) Comparison Group (150 children <3y undergoing elective surgery who on parental history have no significant history of ear disease) Collection of Nasopharyngeal Swab (at time of general anaesthetic for non-ear related surgery) Parental Questionnaire - administered to both subjects and comarison group on the day of surgery This study will be performed as two Phases (Each phase as described above, under two different vaccination schedules): Phase One: Starting April 2011, completion by Dec 31st 2011 (with possible extension to March 31st 2012 if target of 300 subjects not yet recruited). This will capture children vaccinated under the current PCV7 (7 valent pneumococcal vaccination) schedule. Phase Two: Starting April 2013, completion Dec 2013 (with possible extension to March 2014 if target of 300 subjects not yet recruited). This will capture children vaccinated under the new schedule with PCV10 (10 valent pneumococcal vaccination) schedule. Both Phases of the study will be performed in 3 centres: - Starship Childrens Hospital ADHB (Auckland) - Counties Manukau DHB (South Auckland) - Canterbury DHB (Christchurch)

Eligibility

Sex/Gender

All

Age

0 to 3 Years

Healthy volunteers

Inclusion criteria

Elective ventilation tube (grommet) surgery (cases) Elective non-ear related surgery (comparison group)

Exclusion criteria

Cases: Primary or secondary immune deficiency Cystic fibrosis Craniofacial anomalies Subjects who have had one or more doses of PCV10 vaccination Comparison Group: History of recurrent acute otitis media History of Glue Ear (Chronic Otitis Media)

Outcome results