Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax®) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip®) to adults aged ≥60 years: An open-label, randomised trial

Vaccine

Volumn 31, Issue 11, 2013, Pages 1496-1502

  Zimmermann, Ulrich ^a   Gavazzi, Gaëtan ^b   Richard, Patrick ^c   Eymin, Cécile ^c   Soubeyrand, Benoît ^c   Baudin, Martine ^c  

^a Internistische Gemeinschaftspraxis   (Germany)

^b GRENOBLE UNIVERSITY HOSPITAL   (France)

^c SANOFI PASTEUR   (France)

Author keywords

Elderly; Immune response; Inactivated influenza vaccine; Randomised controlled trial; Safety; Tdap IPV

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS VACCINE; FIMBRIA PROTEIN; HEMAGGLUTININ; INFLUENZA VACCINE; PERTACTIN; PERTUSSIS TOXIN;

2009 H1N1 INFLUENZA; AGED; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; FRANCE; GERMANY; HUMAN; HUMORAL IMMUNITY; IMMUNE RESPONSE; IMMUNOGENICITY; INFLUENZA VACCINATION; INJECTION SITE REACTION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PAIN; POLIOMYELITIS; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SWELLING; TACHYCARDIA; UVEITIS;

AGED; ANTIBODIES, BACTERIAL; ANTIBODIES, VIRAL; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; DRUG TOXICITY; FEMALE; FRANCE; GERMANY; HUMANS; IMMUNIZATION, SECONDARY; INFLUENZA VACCINES; MALE; MIDDLE AGED; POLIOVIRUS VACCINE, INACTIVATED; VACCINES, COMBINED; VACCINES, INACTIVATED;

EID: 84874429202     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.12.081     Document Type: Article

References (24)

1. Centers for Disease Control and Prevention (CDC) Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR Morb Mortal Wkly Rep 2011, 60:13-15.
2. Hofmann F. Environmentally and occupationally acquired diseases in adolescents and adulthood: control of diphtheria, tetanus, pertussis, and poliomyelitis through regular booster vaccinations--a European perspective. Rev Environ Health 2005, 20:303-317.
3. Michel J.P. Updated vaccine guidelines for aging and aged citizens of Europe. Expert Rev Vaccines 2010, 9(3 (Suppl.)):7-10.
4. Belmin J., Bouree P., Camus D., Guiso N., Jeandel C., Trivalle C., et al. Vaccination in older adults: development of an educational tool, Vaxisenior, in France. Expert Rev Vaccines 2010, 9:15-20.
5. Gergely A., Bechet S., Goujon C., Pelicot M., Van Der Vilet D., Simons de Fanti A., et al. [Tetanus, poliomyelitis and diphtheria vaccination coverage in elderly Parisian residents in 2006]. Bull Epidemiol Hebdomadaire 2008, 9:61-68.
6. Centers for Disease Control and Prevention (CDC) Tetanus. Epidemiology and prevention of vaccine-preventable diseases. The pink book: course textbook 2011, CDC, Atlanta, p. 13-5. Available from: http://www.cdc.gov/vaccines/pubs/pinkbook/tetanus.html [last accessed 7.12.12]. 12th ed.
7. European Centre for Disease Prevention and Control (ECDC). Annual Epidemiological Report. Reporting on 2009 surveillance data and 2010 epidemic intelligence data; 2011. Available from: [last accessed 7.12.12]. http://ecdc.europa.eu/en/publications/Publications/1111_SUR_Annual_Epidemiological_Report_on_Communicable_Diseases_in_Europe.pdf.
8. Bisgard K.M., Pascual F.B., Ehresmann K.R., Miller C.A., Cianfrini C., Jennings C.E., et al. Infant pertussis: who was the source. Pediatr Infect Dis J 2004, 23:985-989.
9. Centers for Disease Control and Prevention (CDC) Tetanus and pertussis vaccination coverage among adults aged >18 years - United States, 1999 and 2008. MMWR Morb Mortal Wkly Rep 2010, 59:1302-1306.
10. Heininger U. Pertussis immunisation in adolescents and adults. Adv Exp Med Biol 2008, 609:72-97.
11. McNeil S.A., Noya F., Dionne M., Predy G., Meekison W., Ojah C., et al. Comparison of the safety and immunogenicity of concomitant and sequential administration of an adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis (Tdap) vaccine and trivalent inactivated influenza vaccine in adults. Vaccine 2007, 25:3464-3474.
12. Wendelboe A.M., Njamkepo E., Bourillon A., Floret D.D., Gaudelus J., Gerber M., et al. Transmission of Bordetella pertussis to young infants. Pediatr Infect Dis J 2007, 26:293-299.
13. Kaml M., Weiskirchner I., Keller M., Luft T., Hoster E., Hasford J., et al. Booster vaccination in the elderly: their success depends on the vaccine type applied earlier in life as well as on pre-vaccination antibody titers. Vaccine 2006, 24:6808-6811.
14. Fiore A.E., Uyeki T.M., Broder K., Finelli L., Euler G.L., Singleton J.A., et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep 2010, 59:1-62.
15. Nokleby H., Nicoll A. Risk groups and other target groups - preliminary ECDC guidance for developing influenza vaccination recommendations for the season 2010-11. Euro Surveill 2010, 15. pii:19525.
16. Halperin S.A., Smith B., Russell M., Scheifele D., Mills E., Hasselback P., et al. Adult formulation of a five component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults. Pediatr Infect Dis J 2000, 19:276-283.
17. Sanofi Pasteur MSD. Repevax® Summary of Product Characteristics; 2011. Available from: [last accessed 6.12.12]. http://www.medicines.org.uk/emc/medicine/15256.
18. Weston W.M., Chandrashekar V., Friedland L.R., Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Hum Vaccin 2009, 5:858-866.
19. European Medicines Agency (EMEA). ICH Topic E 6 (R1) guideline for good clinical practice; 2012. Available from: [last accessed 7.12.12]. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf.
20. World Medical Association. WMA Declaration of Helsinki - ethical principles for medical research involving human subjects; 2012. Available from: [last accessed 7.12.12]. http://www.wma.net/en/30publications/10policies/b3/index.html.
21. European Agency for the Evaluation of Medicinal Products. Note for guidance on harmonisation of requirements for influenza vaccines; 1997. Available from: [last accessed 7.12.12]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf.
22. World Health Organization. The immunological basis for immunization series. Module 4: Pertussis Update 2009; 2010. Available from: [last accessed 7.12.12]. http://whqlibdoc.who.int/publications/2010/9789241599337_eng.pdf.
23. Storsaeter J., Hallander H.O., Gustafsson L., Olin P. Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine 1998, 16:1907-1916.
24. de Jong J.C., Palache A.M., Beyer W.E., Rimmelzwaan G.F., Boon A.C., Osterhaus A.D. Haemagglutination-inhibiting antibody to influenza virus. Dev Biol (Basel) 2003, 115:63-73.