Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: A double-blind, cluster randomised phase 3-4 trial

The Lancet Infectious Diseases

Volumn 14, Issue 3, 2014, Pages 205-212

  Palmu, Arto A ^a   Jokinen, Jukka ^a   Nieminen, Heta ^a   Rinta Kokko, Hanna ^a   Ruokokoski, Esa ^a   Puumalainen, Taneli ^c   Borys, Dorota ^b   Lommel, Patricia ^b   Traskine, Magali ^b   Moreira, Marta ^b   Schuerman, Lode ^b   Kilpi, Terhi M ^a  

^a NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^b GSK   (Belgium)

^c GLAXOSMITHKLINE   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

AMOXICILLIN; ANTIBIOTIC AGENT; AZITHROMYCIN; CEFACLOR; CEFUROXIME; CLARITHROMYCIN; CLAVULANIC ACID; HEPATITIS A VACCINE; HEPATITIS B VACCINE; PENICILLIN V; PNEUMOCOCCUS VACCINE; SULFADIAZINE; TRIMETHOPRIM;

ACUTE OTITIS MEDIA; ANTIBIOTIC THERAPY; ARTICLE; CHILD; CLUSTER ANALYSIS; COHORT ANALYSIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; FINLAND; FOLLOW UP; HOSPITALIZED CHILD; HOSPITALIZED INFANT; HUMAN; INCIDENCE; INFANT; MAJOR CLINICAL STUDY; NEWBORN; OUTCOME ASSESSMENT; OUTPATIENT; PHASE 3 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL; PNEUMOCOCCAL INFECTION; PRESCRIPTION; PURCHASING; RANDOMIZED CONTROLLED TRIAL; REGISTER; VACCINATION;

ANTI-BACTERIAL AGENTS; BACTERIAL PROTEINS; CARRIER PROTEINS; DOUBLE-BLIND METHOD; DRUG PRESCRIPTIONS; FEMALE; HUMANS; IMMUNOGLOBULIN D; INCIDENCE; INFANT; LIPOPROTEINS; MALE; OTITIS MEDIA; OUTPATIENTS; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; VACCINES, CONJUGATE;

EID: 84894374320     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(13)70338-4     Document Type: Article

References (23)

1. Sabuncu E, David J, Bernède-Bauduin C, et al. Significant reduction of antibiotic use in the community after a nationwide campaign in France, 2002-2007. PLoS Med 2009, 6:e1000084.
2. Grijalva CG, Nuorti JP, Griffin MR Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA 2009, 302:758-766.
3. Bluestone CD, Stephenson JS, Martin LM Ten-year review of otitis media pathogens. Pediatr Infect Dis J 1992, 11:S7-11.
4. Kilpi T, Herva E, Kaijalainen T, et al. Bacteriology of acute otitis media in a cohort of Finnish children followed for the first two years of life. Pediatr Infect Dis J 2001, 20:654-662.
5. Prymula R, Peeters P, Chrobok V, et al. Pneumococcal capsular polysaccharides conjugated to protein D provide protection against otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomized double blind efficacy study. Lancet 2006, 367:740-748.
6. Rautakorpi UM, Huikko S, Honkanen P, et al. The Antimicrobial Treatment Strategies (MIKSTRA) program: a 5-year follow-up of infection-specific antibiotic use in primary health care and the effect of implementation of treatment guidelines. Clin Infect Dis 2006, 42:1221-1230.
7. Dommergues MA, Hentgen V Decreased paediatric antibiotic consumption in France between 2000 and 2010. Scand J Infect Dis 2012, 44:495-501.
8. Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 2001, 344:403-409.
9. Kilpi T, Ahman H, Jokinen J, 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. Clin Infect Dis 2003, 37:1155-1164.
10. Taylor S, Marchisio P, Vergison A, Harriague J, Hausdorff WP, Haggard M Impact of pneumococcal conjugate vaccination on otitis media: a systematic review. Clin Infect Dis 2012, 54:1765-1773.
11. Palmu AA, Jokinen J, Borys D, 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, 381:214-222.
12. Vesikari T, Forstén A, Seppä I, et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in healthy Finnish infants and toddlers. ESPID 2013, Milan, Italy, May 28 to June 1, 2013. Abstr 420.
13. Otitis media (acute). Current care guideline 2010, Working group appointed by the Finnish Medical Society Duodecim, the Finnish Paediatric Societythe Finnish Paediatric Society, the Finnish Otolaryngological Society and the Finnish Association for General Practicethe Finnish Otolaryngological Society and the Finnish Association for General Practice, Finnish Medical Society Duodecim, Helsinki, (accessed July 2, 2013). http://www.kaypahoito.fi.
14. Donner A, Klar N Design and analysis of cluster randomization trials in health research 2000, Arnold, London.
15. Wei LJ, Lin DY, Weissfeld L Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc 1989, 84:1065-1073.
16. Lin DY, Wei LJ The robust inference for the Cox proportional hazards model. J Am Stat Assoc 1989, 82:1075-1078.
17. Fireman B, Black SB, Shinefield HR, Lee J, Lewis E, Ray P Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J 2003, 22:10-16.
18. 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. Pediatr Infect Dis J 2001, 20:951-958.
19. Esposito S, Lizioli A, Lastrico A, et al. Impact on respiratory tract infections of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months of age. Respir Res 2007, 8:12.
20. 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, 121:253-260.
21. Tähtinen PA, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohola A A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med 2011, 364:116-126.
22. Hoberman A, Paradise JL, Rockette HE, et al. Treatment of acute otitis media in children under 2 years of age. N Engl J Med 2011, 364:105-115.
23. Arguedas A, Kvaerner K, Liese J, Schilder AG, Pelton SI Otitis media across nine countries: disease burden and management. Int J Pediatr Otorhinolaryngol 2010, 74:1419-1424.