Pneumococcal vaccination does not prevent recurrence of acute otitis media in older children

Drake-Lee, Adrian MMEd, PhD FRCS

Queen Elizabeth Hospital, Birmingham, UK

Abstracted from:Veenhoven R, Bogaert D, Uiterwaal C et al. Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study. Lancet 2003; 361: 2189-2195 .

Sources of funding: This study was funded by the Netherlands Organisation for Health Research and Development ZonMw and the Netherlands Health Insurance Company Zilveren Kruis-Achmea.

Correspondence to: Elisabeth Sanders, Department of Paediatric Immunology, Wilhelmina Children's Hospital/University Medical Center Utrecht, Utrecht, Netherlands. E-mail: [email protected]

Abstract provided by Bazian Ltd., London

Evidence-based Healthcare 8(1):p 55-56, March 2004.

BACKGROUND

Pneumococcal conjugate vaccination of children aged 2, 4, 6 and 12 to 15 months reduces the incidence of recurrent acute otitis media. The effectiveness of combined pneumococcal conjugate vaccination and pneumococcal polysaccharide vaccination in preventing recurrent AOM in older children is not known.

OBJECTIVE

To determine whether a combined pneumococcal conjugate (PCV7) and pneumococcal polysaccharide (PPSV23) vaccination prevents recurrent acute otitis media in children aged > 1 year.

SETTING

One general hospital and one tertiary care hospital in the Netherlands; April 1998 to January 2002.

METHOD

Double-blind randomised controlled trial.

PARTICIPANTS

Three hundred and eighty-three children aged 1 to 7 years old with a history of ≥ 2 episodes of acute otitis media in the previous year. Main exclusion criteria were: primary or secondary immunodeficiency, cystic fibrosis, craniofacial abnormalities, chromosomal abnormalities, and history of severe adverse events during vaccination. Participants were stratified according to age and number of episodes of acute otitis media in the previous year.

INTERVENTION

The intervention received was age dependent. Participants in the pneumococcal group aged 12 to 24 months were immunised twice with PCV7, and 6 months later with PPSV23. Similar aged control participants were immunised with hepatitis B. Participants in the pneumococcal group aged 25 to 84 months were immunised once with PCV7 and 7 months later with PPSV23. Control participants of similar age were immunised with hepatitis A vaccine.

OUTCOMES

Incidence of acute otitis media episodes during 18 month follow-up.

MAIN RESULTS

There was a trend towards a higher rate of recurrence of acute otitis media in the pneumococcal vaccine group than in the control vaccination group over the 18 month follow-up period (recurrence rate per-person year: 1.1 episodes with pneumococcal vaccine versus 0.83 episodes with control vaccine; RR 1.29, 95% CI 1.02 to 1.62, per-protocol analysis; RR 1.25, 95% CI 0.99 to 1.57, intention-to-treat analysis).

AUTHORS' CONCLUSIONS

Combined pneumococcal conjugate and polysaccharide vaccination does not prevent recurrence of acute otitis media in children aged 1 year and over.

Notes Subgroup analysis showed that pneumococcal vaccination in children aged 25 to 84 months significantly increased the rate of recurrence of AOM compared with the control vaccination (RR of recurrence rates per-person year 1.45, 95% CI 1.09 to 1.94). There was no significant difference in recurrence rate of AOM in children in the 12 to 24 month age group between the pneumococcal and control vaccination groups (RR of recurrence rates per-person year 1.07, 95% CI 0.72 to 1.60). The theory behind the use of different pneumococcal and control vaccination programmes for the two age groups was not explained and may have differentially influenced the outcomes in these two age groups.