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Long-term effect of pneumococcal conjugate vaccines on tympanostomy tube placements
Ilona Sarasoja1, Jukka Jokinen, Mika Lahdenkari
1Department of Vaccination and Immune Protection, National Institute for Health and Welfare, Tampere, Finland.
Insights
The 7-valent pneumococcal conjugate vaccine (PncCRM) effectively reduced tympanostomy tube placements in children up to age five. While no further impact was seen after age five, the initial benefit of pneumococcal conjugate vaccines was sustained.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Otolaryngology
Background:
- Previous studies demonstrated the efficacy of the 7-valent pneumococcal conjugate vaccine (PncCRM) in reducing tympanostomy tube placements through age 4-5.
- This study extends the evaluation to assess the long-term effectiveness of PncCRM and PncOMPC pneumococcal conjugate vaccines up to 13 years of age.
Purpose of the Study:
- To evaluate the effectiveness of PncCRM and PncOMPC pneumococcal conjugate vaccines in preventing tympanostomy tube placements from 2 to 13 years of age.
- To determine the age-dependent impact of these vaccines on otitis media surgical interventions.
Main Methods:
- A randomized controlled trial involving 2497 children vaccinated with PncCRM, PncOMPC, or a hepatitis B control vaccine from infancy.
- Data on tympanostomy tube placements were collected from comprehensive health registers covering hospital and private office procedures.
- Vaccine efficacy was calculated by comparing the incidence of tympanostomies in vaccine groups versus the control group between ages 2 and 13.
Main Results:
- A total of 535 tympanostomy tube placements were recorded between ages 2 and 13 in the control group (cumulative incidence 14.6%).
- Vaccine effectiveness was significant for PncCRM up to age 5 (34% effectiveness), but not for PncOMPC in the same age group (6% effectiveness).
- No significant vaccine effectiveness was observed for either PncCRM or PncOMPC in the older age group (6 to 13 years).
Conclusions:
- The PncCRM vaccine demonstrated effectiveness in reducing tympanostomy tube placements through age 5.
- No additional impact on surgical procedures was observed beyond age 5.
- The benefits achieved by the PncCRM vaccine in early childhood were sustained over the follow-up period.
Background:
We have previously shown that the 7-valent pneumococcal conjugate vaccine (PncCRM) given in infancy is effective in reducing tympanostomy tube placements up to 4 to 5 years of age. This study aimed to assess the effectiveness of pneumococcal conjugate vaccines PncCRM and PncOMPC from 2 up to 13 years of age.
Methods:
Altogether 2497 children participated in the Finnish Otitis Media Vaccine trial conducted in 1995 to 1999 and were vaccinated at 2, 4, 6 and 12 months of age with PncCRM or PncOMPC or hepatitis B vaccine as controls. The data for tympanostomy tube placements were collected from health registers including hospital and private office operations. Vaccine efficacy was estimated by comparing incidences of tympanostomies from 2 to 12-13 years of age in each of the pneumococcal vaccine groups with the control group.
Results:
Register data were searched for 2474 subjects. A total of 535 tympanostomy tube placements were identified in the health registers from 1998 through 2008 with a cumulative incidence of 14.6% from 2 to 13 years of age in the control group. The vaccine impact was age-dependent: from 2 through 5 years of age the vaccine effectiveness was 34% (95% confidence interval: 1% to 52%) for PncCRM and 6% (-28 to 31) for the PncOMPC vaccine. For the age group of 6 to 12-13 years the vaccine effectiveness estimates for the PncCRM and PncOMPC groups were -13% (-137 to 46) and -2% (-123 to 54), respectively.
Conclusions:
PncCRM vaccine reduced the tympanostomy tube placements up to 5 years of age. No impact on new surgical procedures could be demonstrated after that but the benefit achieved was sustained.
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