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Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study.
Lancet 2003; 361(9376):2189-95Lct

Abstract

BACKGROUND

Pneumococcal conjugate vaccine prevents recurrent acute otitis media (AOM) in infants immunised at 2, 4, 6, and 12-15 months of age. We aimed to find out whether this vaccine also prevents AOM in older children who have had previous episodes of AOM.

METHODS

In this double-blind, randomised study, we enrolled 383 patients aged 1-7 years who had had two or more episodes of AOM in the year before entry. Randomisation was stratified in four groups according to age (12-24 months vs 25-84 months) and the number of previous AOM episodes (two or three episodes vs four or more episodes). Children received either 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine, or hepatitis A or B vaccines. They were followed up for 18 months for recurrence of AOM. We also cultured samples of middle-ear fluid and nasopharyngeal swabs to assess association of pneumococcal serotypes with AOM after vaccination.

FINDINGS

We noted no reduction of AOM episodes in the pneumococcal vaccine group compared with controls (intention-to-treat analysis: rate ratio 1.25, 95% CI 0.99-1.57). Although nasopharyngeal carriage of pneumococci of serotypes included in the conjugate-vaccine was greatly reduced after pneumococcal vaccinations, immediate and complete replacement by non-vaccine pneumococcal serotypes took place.

INTERPRETATION

These data do not lend support to the use of pneumococcal conjugate vaccine to prevent otitis media in previously unvaccinated toddlers and children with a history of recurrent AOM.

Authors+Show Affiliations

Department of Paediatrics, Spaarne Hospital, Haarlem, Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12842372

Citation

Veenhoven, Reinier, et al. "Effect of Conjugate Pneumococcal Vaccine Followed By Polysaccharide Pneumococcal Vaccine On Recurrent Acute Otitis Media: a Randomised Study." Lancet (London, England), vol. 361, no. 9376, 2003, pp. 2189-95.
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(9376):2189-95.
Veenhoven, R., Bogaert, D., Uiterwaal, C., Brouwer, C., Kiezebrink, H., Bruin, J., ... Sanders, E. (2003). Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study. Lancet (London, England), 361(9376), pp. 2189-95.
Veenhoven R, et al. Effect of Conjugate Pneumococcal Vaccine Followed By Polysaccharide Pneumococcal Vaccine On Recurrent Acute Otitis Media: a Randomised Study. Lancet. 2003 Jun 28;361(9376):2189-95. PubMed PMID: 12842372.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomised study. AU - Veenhoven,Reinier, AU - Bogaert,Debby, AU - Uiterwaal,Cuno, AU - Brouwer,Carole, AU - Kiezebrink,Herma, AU - Bruin,Jacob, AU - IJzerman,Ed, AU - Hermans,Peter, AU - de Groot,Ronald, AU - Zegers,Ben, AU - Kuis,Wietse, AU - Rijkers,Ger, AU - Schilder,Anne, AU - Sanders,Elisabeth, PY - 2003/7/5/pubmed PY - 2003/7/18/medline PY - 2003/7/5/entrez SP - 2189 EP - 95 JF - Lancet (London, England) JO - Lancet VL - 361 IS - 9376 N2 - BACKGROUND: Pneumococcal conjugate vaccine prevents recurrent acute otitis media (AOM) in infants immunised at 2, 4, 6, and 12-15 months of age. We aimed to find out whether this vaccine also prevents AOM in older children who have had previous episodes of AOM. METHODS: In this double-blind, randomised study, we enrolled 383 patients aged 1-7 years who had had two or more episodes of AOM in the year before entry. Randomisation was stratified in four groups according to age (12-24 months vs 25-84 months) and the number of previous AOM episodes (two or three episodes vs four or more episodes). Children received either 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine, or hepatitis A or B vaccines. They were followed up for 18 months for recurrence of AOM. We also cultured samples of middle-ear fluid and nasopharyngeal swabs to assess association of pneumococcal serotypes with AOM after vaccination. FINDINGS: We noted no reduction of AOM episodes in the pneumococcal vaccine group compared with controls (intention-to-treat analysis: rate ratio 1.25, 95% CI 0.99-1.57). Although nasopharyngeal carriage of pneumococci of serotypes included in the conjugate-vaccine was greatly reduced after pneumococcal vaccinations, immediate and complete replacement by non-vaccine pneumococcal serotypes took place. INTERPRETATION: These data do not lend support to the use of pneumococcal conjugate vaccine to prevent otitis media in previously unvaccinated toddlers and children with a history of recurrent AOM. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/12842372/Effect_of_conjugate_pneumococcal_vaccine_followed_by_polysaccharide_pneumococcal_vaccine_on_recurrent_acute_otitis_media:_a_randomised_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(03)13772-5 DB - PRIME DP - Unbound Medicine ER -