Intervention Review

You have free access to this content

Pneumococcal conjugate vaccines for preventing otitis media

  1. Alexandre C Fortanier1,
  2. Roderick P Venekamp2,
  3. Chantal WB Boonacker1,
  4. Eelko Hak3,
  5. Anne GM Schilder4,
  6. Elisabeth AM Sanders5,
  7. Roger AMJ Damoiseaux1,*

Editorial Group: Cochrane Acute Respiratory Infections Group

Published Online: 2 APR 2014

Assessed as up-to-date: 3 DEC 2013

DOI: 10.1002/14651858.CD001480.pub4


How to Cite

Fortanier AC, Venekamp RP, Boonacker CWB, Hak E, Schilder AGM, Sanders EAM, Damoiseaux RAMJ. Pneumococcal conjugate vaccines for preventing otitis media. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD001480. DOI: 10.1002/14651858.CD001480.pub4.

Author Information

  1. 1

    University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

  2. 2

    University Medical Center Utrecht, Department of Otorhinolaryngology & Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands

  3. 3

    University Medical Center Groningen, Department of Epidemiology, Groningen, Netherlands

  4. 4

    Faculty of Brain Sciences, University College London, evidENT, Ear Institute, London, UK

  5. 5

    Wilhelmina Children's Hospital, University Medical Center Utrecht, Department of Pediatric Immunology and Infectious Diseases, Utrecht, Netherlands

*Roger AMJ Damoiseaux, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, HP: Str. 6.131, PO Box 85500, Utrecht, 3508 GA, Netherlands. R.A.M.J.Damoiseaux@umcutrecht.nl. rdamoiseaux@hotmail.com, R.DAMOISEAUX@tiscali.nl.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 2 APR 2014

SEARCH

References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Black 2000 {published data only}
  • Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatric Infectious Disease Journal 2000;19(3):187-95.
Dagan 2001 {published data only}
  • Dagan R, Sikuler-Cohen M, Zamir O, Janco J, Givon-Lavi N, Fraser D. Effect of a conjugate pneumococcal vaccine on the occurrence of respiratory infections and antibiotic use in day-care center attendees. Pediatric Infectious Disease Journal 2001;20(10):951-8.
Eskola 2001 {published data only}
Fireman 2003 {published data only}
Jansen 2008 {published data only}
  • Jansen AG, Sanders EA, Hoes AW, van Loon AM, Hak E. Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children: a randomized, double-blind, placebo-controlled trial. Journal of Pediatrics 2008;153:764-70.
Kilpi 2003 {published data only}
  • Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, et al. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clinical Infectious Diseases 2003;37(9):1155-64.
O'Brien 2008 {published data only}
  • O'Brien KL, David AB, Chandran A, Moulton LH, Reid R, Weatherholtz R, et al. Randomized, controlled trial efficacy of pneumococcal conjugate vaccine against otitis media among Navajo and White Mountain Apache infants. Pediatric Infectious Disease Journal 2008;27:71-3.
Palmu 2009 {published data only}
Prymula 2006 {published data only}
  • Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typeable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006;367(9512):740-8.
Van Kempen 2006 {published data only}
  • Van Kempen MJ, Vermeiren JS, Vaneechoutte M, Claeys G, Veenhoven RH, Rijkers GT, et al. Pneumococcal conjugate vaccination in children with recurrent acute otitis media: a therapeutic alternative?. International Journal of Pediatric Otorhinolaryngology 2006;70(2):275-85.
Veenhoven 2003 {published data only}
  • Veenhoven R, Bogaert D, Uiterwaal C, Brouwer C, Kiezebrink H, Bruin J, 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.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Gisselsson Solen 2011 {published data only}
Jokinen 2012 {published data only}
Le 2007 {published data only}
  • Le TM, Rovers MM, Veenhoven RH, Sanders EA, Schilder AG. Effect of pneumococcal vaccination on otitis media with effusion in children older than 1 year. European Journal of Pediatrics 2007;166:1049-52.
Roy 2011 {unpublished data only}
  • Roy E, Steinhoff MC, Omer SB, Arifeen SE, Raqib R, Breiman R, et al. Clinical effectiveness of pneumococcal conjugate vaccine in suppurative otitis media: a randomized controlled trial in Bangladeshi Infants. Pediatric Academic Societies Annual Meeting (April 28 - May 1). Boston, USA, 2011.

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
NCT00466947 {published data only}
  • NCT00466947. COMPAS: Phase III, Double-blind, Randomized Study to Demonstrate Efficacy of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A) Against Community Acquired Pneumonia and Acute Otitis Media (AOM). clinicaltrials.gov/show/NCT00466947 (accessed 1 December 2013).
NCT00861380 {published data only}
  • NCT00861380. Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease (FinIP). clinicaltrials.gov/show/NCT00861380 (accessed 1 December 2013).
NCT01174849 {published data only}
  • NCT01174849. Pneumococcal Vaccines Early and in Combination (PREVIX_COMBO). clinicaltrials.gov/show/NCT01174849 (accessed 1 December 2013).
NCT01545375 {published data only}
  • NCT01545375. Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children. clinicaltrials.gov/show/NCT01545375 (accessed 1 December 2013).
NCT01735084 {published data only}
  • NCT01735084. Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life (PREV-IX_B). clinicaltrials.gov/show/NCT01735084 (accessed 1 December 2013).

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Alonso 2013
  • Alonso M, Marimon JM, Ercibengoa M, Pérez-Yarza EG, Pérez-Trallero E. Dynamics of Streptococcus pneumoniae serotypes causing acute otitis media isolated from children with spontaneous middle-ear drainage over a 12-year period (1999-2010) in a region of northern Spain. PLoS ONE 2013;8(1):e54333.
Andersen 1982
Arason 1996
  • Arason VA, Kristinsson KG, Sigurdsson JA, Stefánsdóttir G, Mölstad S, Gudmundsson S. Do antimicrobials increase the carriage rate of penicillin resistant pneumococci in children? Cross sectional prevalence study. BMJ 1996;313(7054):387-91.
Block 2004
  • Block SL, Hedrick J, Harrison CJ, Tyler R, Smith A, Findlay R, et al. Community-wide vaccination with the heptavalent pneumococcal conjugate significantly alters the microbiology of acute otitis media. Pediatric Infectious Disease Journal 2004;23(9):829-33.
Block 2006
Bluestone 1992
Boonacker 2011
  • Boonacker CW, Broos PH, Sanders EA, Schilder AG, Rovers MM. Cost effectiveness of pneumococcal conjugate vaccination against acute otitis media in children: a review. Pharmacoeconomics 2011;29(3):199-211.
Casey 2004
Casey 2013
  • Casey JR, Kaur R, Friedel VC, Pichichero ME. Acute otitis media otopathogens during 2008 to 2010 in Rochester, New York. Pediatric Infectious Disease Journal 2013;32:805-9.
Coker 2010
  • Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, et al. Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review. JAMA 2010;304:2161-9.
Couloigner 2012
  • Couloigner V, Levy C, François M, Bidet P, Cohen R, et al. Pathogens implicated in acute otitis media failures after 7-valent pneumococcal conjugate vaccine implementation in France: distribution, serotypes, and resistance levels. Pediatric Infectious Disease Journal 2012;31(2):154-8.
Dagan 1997
  • Dagan R, Melamed R, Zamir O, Leroy O. Safety and immunogenicity of tetravalent pneumococcal vaccines containing 6B, 14, 19F and 23F polysaccharides conjugated to either tetanus toxoid or diphtheria toxoid in young infants and their boosterability by native polysaccharide antigens. Pediatric Infectious Disease Journal 1997;16(11):1053-9.
Dagan 2000
Dagan 2013
  • Dagan R, Leibovitz E, Greenberg D, Bakaletz L, Givon-Lavi N. Mixed pneumococcal-nontypeable Haemophilus influenzae otitis media is a distinct clinical entity with unique epidemiologic characteristics and pneumococcal serotype distribution. Journal of Infectious Diseases 2013;208(7):1152-60.
Del Castillo 1998
  • del Castillo F, Baquero-Artigao F, Garcia-Perea A. Influence of recent antibiotic therapy on antimicrobial resistance of Streptococcus pneumoniae in children with acute otitis media in Spain. Pediatric Infectious Disease Journal 1998;17(2):94-7.
Eskola 1999
Forsgren 2008
  • Forsgren A, Riesbeck K, Janson H. Protein D of Haemophilus influenzae: a protective nontypeable H. influenzae antigen and a carrier for pneumococcal conjugate vaccines. Clinical Infectious Diseases 2008;46(5):726-31.
Goossens 2007
  • Goossens H, Ferech M, Coenen S, Stephens P. Comparison of outpatient systemic antibacterial use in 2004 in the United States and 27 European countries. Clinical Infectious Diseases 2007;44(8):1091-5.
Hausdorff 2013
  • Hausdorff W, Mrkvan T, Moreira M, Ruiz Guinazu J, Borys D. Impact of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on pneumococcal disease. Proceedings of the 28th International Congress of Chemotherapy and Infection Incorporating the 14th Asia-Pacific Congress of Clinical Microbiology and Infection; 2013 June 5-8; Yokohama, Japan. International Journal of Antimicrobial Agents 2013;42 Suppl 2:S157.
Heikkinen 1999
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Intervention 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Howie 1970
Jacobs 1998
  • Jacobs MR, Dagan R, Appelbaum PC, Burch DJ. Prevalence of antimicrobial-resistant pathogens in middle ear fluid: multinational study of 917 children with acute otitis media. Antimicrobial Agents and Chemotherapy 1998;42(3):589-95.
Jahn-Eimermacher 2007
  • Jahn-Eimermacher A, du Prel JB, Schmitt HJ. Assessing vaccine efficacy for the prevention of acute otitis media by pneumococcal vaccination in children: a methodological overview of statistical practice in randomized controlled clinical trials. Vaccine 2007;25(33):6237-44.
Kaplan 1997
Kaur 2013
  • Kaur R, Casey JR, Pichichero ME. Relationship with original pathogen in recurrence of acute otitis media after completion of amoxicillin/clavulanate: bacterial relapse or new pathogen. Pediatric Infectious Disease Journal 2013;32(11):1159-62.
Kvaerner 1997
Lefebvre 2011
  • Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. Available from www.cochrane-handbook.org. Chichester, UK: Wiley-Blackwell, 2011.
Luotonen 1981
  • Luotonen J, Herva E, Karma P, Timonen M, Leinonen M, Makela PH. The bacteriology of acute otitis media in children with special reference to Streptococcus pneumoniae as studied by bacteriological and antigen detection methods. Scandinavian Journal of Infectious Diseases 1981;13(3):177-83.
Magnus 2012
  • Magnus MC, Vestrheim DF, Nystad W, Håberg SE, Stigum H. Decline in early childhood respiratory tract infections in the Norwegian mother and child cohort study after introduction of pneumococcal conjugate vaccination. Pediatric Infectious Disease Journal 2012;31(9):951-5.
Marom 2014
  • Marom T, Tan A, Wilkinson GS, Pierson KS, Freeman JL, Chonmaitree T. Trends in otitis media-related health care use in the United States, 2001-2011. JAMA Pediatrics 2014;168(1):68-75.
McCullagh 1989
  • McCullagh P, Nelder JA. Generalized Linear Models. London: Chapman and Hall, 1989.
McEllistrem 2005
  • McEllistrem MC, Adams JM, Patel K, Medelsohn AB, Kaplan SL, Bradley JS, et al. Acute otitis media due to penicillin-non-susceptible Streptococcus pneumoniae before and after the introduction of the pneumococcal conjugate vaccine. Clinical Infectious Diseases 2005;40:1738-44.
Moulton 2001
Niemela 1999
O'Brien 2003
  • O'Brien KL, Moulton LH, Reid R, Weatherholtz R, Oski J, Brown L, et al. Efficacy and safety of a seven-valent conjugate pneumococcal vaccine in American Indian children: group randomized trial. Lancet 2003;362(9381):255-61.
O'Brien 2009
Obaro 1996
Palmu 2008
  • Palmu A, Jokinen J, Kilpi T, Finnish Otitis Media Study Group. Impact of different case definitions for acute otitis media on the efficacy estimates of a pneumococcal conjugate vaccine. Vaccine 2008;26(20):2466-70.
Palmu 2013a
  • Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013;381(9862):214-22.
Palmu 2013b
  • Palmu AA, Jokinen J, Nieminen H, Rinta-Kokko H, Ruokokoski E, Puumalainen T, et al. Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster randomised phase 3-4 trial. Lancet Infectious Diseases 2013;14(3):205-12. [DOI: 10.1016/S1473-3099(13)70338-4]
Pavia 2009
  • Pavia M, Bianco A, Nobile CG, Marinelli P, Angelillo IF. Efficacy of pneumococcal vaccination in children younger than 24 months: a meta-analysis. Pediatrics 2009;123(6):e1103-10.
Pichichero 2007
Pichichero 2013
  • Pichichero ME, Casey JR, Almudevar A. Nonprotective responses to pediatric vaccines occur in children who are otitis prone. Pediatric Infectious Disease Journal 2013;32(11):1163-8.
Poehling 2007
  • Poehling KA, Szilagyi PG, Grijalva CG, Martin SW, LaFleur B, Mitchel E, et al. Reduction of frequent otitis media and pressure-equalizing tube insertions in children after introduction of pneumococcal conjugate vaccine. Pediatrics 2007;119(4):707-15.
Rovers 2006
Shinefield 1999
  • Shinefield HR, Black S, Ray P, Chang I, Lewis N, Fireman B, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatric Infectious Disease Journal 1999;18(9):757-63.
Somech 2011
  • Somech I, Dagan R, Givon-Lavi N, Porat N, Raiz S, Leiberman A, et al. Distribution, dynamics and antibiotic resistance patterns of Streptococcus pneumoniae serotypes causing acute otitis media in children in southern Israel during the 10 year-period before the introduction of the 7-valent pneumococcal conjugate vaccine. Vaccine 2011;29:4202-9.
Sox 2008
Spijkerman 2012
  • Spijkerman J, Prevaes SM, van Gils EJ, Veenhoven RH, Bruin JP, Bogaert D, et al. Long-term effects of pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae,S. aureus,H. influenzae and M. catarrhalis. PloS One 2012;7(6):e39730.
Spiro 2008
Taylor 2012
  • Taylor S, Marchisio P, Vergison A, Harriague J, Hausdorff WP, Haggard M. Impact of pneumococcal conjugate vaccination on otitis media: a systematic review. Clinical Infectious Diseases 2012;54(12):1765-73.
Teele 1989
  • Teele DW, Klein JO, Rosner B. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. Journal Infectious Disease 1989;160:83-94.
Van den Bergh 2012
  • van den Bergh MR, Biesbroek G, Rossen JW, de Steenhuijsen Piters WA, Bosch AA, van Gils EJ, et al. Associations between pathogens in the upper respiratory tract of young children: interplay between viruses and bacteria. PloS One 2012;7(10):e47711.
Van den Bergh 2013
  • van den Bergh MR, Spijkerman J, Swinnen KM, François NA, Pascal TG, Borys D, et al. Effects of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine on nasopharyngeal bacterial colonization in young children: a randomized controlled trial. Clinical Infectious Diseases 2013;56(3):e30-9.
Veenhoven 2004
  • Veenhoven RH, Bogaert D, Schilder AG, Rijkers GT, Uiterwaal CS, Kiezebrink HH, et al. Nasopharyngeal pneumococcal carriage after combined pneumococcal conjugate and polysaccharide vaccination in children with a history of recurrent acute otitis media. Clinical Infectious Diseases 2004;39(7):911-9.
Venekamp 2013
WHO 2012
Wiertsema 2011
  • Wiertsema SP, Kirkham LA, Corscadden KJ, Mowe EN, Bowman JM, Jacoby P, et al. Predominance of nontypeable Haemophilus influenzae in children with otitis media following introduction of a 3+0 pneumococcal conjugate vaccine schedule. Vaccine 2011;29(32):5163-70.
Wiertsema 2012
  • Wiertsema SP, Corscadden KJ, Mowe EN, Zhang G, Vijayasekaran S, Coates HL, et al. IgG responses to pneumococcal and Haemophilus influenzae protein antigens are not impaired in children with a history of recurrent acute otitis media. PLoS One 2012;7(11):e49061.
Zhou 2008
  • Zhou F, Shefer A, Kong Y, Nuorti JP. Trends in acute otitis media-related health care utilization by privately insured young children in the United States, 1997-2004. Pediatrics 2008;121:253-60.

References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
  5. References to other published versions of this review
Jansen 2009
Straetemans 2002
  • Straetemans M, Sanders EA, Veenhoven RH, Schilder AG, Damoiseaux RA, Zielhuis GA. Pneumococcal vaccines for preventing otitis media. Cochrane Database of Systematic Reviews 2002, Issue 2. Art, No.: CD001480. [DOI: 10.1002/14651858.CD001480]
Straetemans 2003
  • Straetemans M, Sanders EAM, Veenhoven RH, Schilder AGM, Damoiseaux RAMJ, Zielhuis GA. Review of randomized controlled trials on pneumococcal vaccination for prevention of otitis media. Pediatric Infectious Disease Journal 2003;22(6):515-24.
Straetemans 2004
  • Straetemans M, Sanders EAM, Veenhoven RH, Schilder AGM, Damoiseaux RAMJ, Zielhuis GA. Pneumococcal vaccines for preventing otitis media. Cochrane Database of Systematic Reviews 2004, Issue 1. [DOI: 10.1002/14651858.CD001480.pub2]