Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age

Pediatric Infectious Disease Journal

Volumn 31, Issue 5, 2012, Pages 494-500

  Vesikari, Timo ^a   Block, Stan L ^b   Guerra, Fernando ^c   Lattanzi, Maria ^d   Holmes, Sandra ^e   Izu, Allen ^e   Gaitatzis, Nicolaos ^f   Hilbert, Anne Katrin ^f   Groth, Nicola ^d  

^a UNIVERSITY OF TAMPERE MEDICAL SCHOOL   (Finland)

^b Kentucky Pediatric Research Institute   (United States)

^c San Antonio Metropolitan Health District Immunization   (United States)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^e NOVARTIS VACCINES AND DIAGNOSTICS   (United States)

^f GSK Marburg Vaccines and Diagnostics   (Germany)

Author keywords

Cell culture; Children; Immunogenicity; Safety; Vaccine

Indexed keywords

CELL ANTIGEN; EGG DERIVED SUBUNIT TRIVALENT INFLUENZA VACCINE; INFLUENZA VACCINE; MAMMALIAN CELL CULTURE DERIVED INFLUENZA VACCINE; UNCLASSIFIED DRUG;

ADOLESCENT; ANTIBODY BLOOD LEVEL; ARTHRALGIA; ARTICLE; CHILD; CHILL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERANCE; ECCHYMOSIS; ERYTHEMA; FATIGUE; FEVER; GEOMETRY; HEADACHE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H3N2; INJECTION SITE INDURATION; MALAISE; MULTICENTER STUDY; MYALGIA; NORMAL HUMAN; PAIN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEROCONVERSION; SIDE EFFECT; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; SWEATING; SWELLING; VACCINATION;

ADOLESCENT; ANIMALS; ANTIBODIES, VIRAL; CELL LINE; CHICK EMBRYO; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; TREATMENT OUTCOME; VACCINES, SUBUNIT;

EID: 84860244823     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31824bb179     Document Type: Article

References (25)

1. Heikkinen T, Silvennoinen H, Peltola V, et al. Burden of infl uenza in children in the community. J Infect Dis. 2004;190:1369-1373.
2. Poehling KA, Edwards KM, Weinberg GA, et al.; New Vaccine Surveillance Network. The underrecognized burden of infl uenza in young children. N Engl J Med. 2006;355:31-40.
3. Thompson WW, Shay DK, Weintraub E, et al. Infl uenza-associated hospitalizations in the United States. JAMA. 2004;292:1333-1340.
4. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with infl uenza and respiratory syncytial virus in the United States. JAMA. 2003;289:179-186.
5. World Health Organization. Infl uenza vaccines. WHO position paper. Wkly Epidemiol Rec. 2005;33:279-287.
6. Reichert TA, Sugaya N, Fedson DS, et al. The Japanese experience with vaccinating schoolchildren against infl uenza. N Engl J Med. 2001;344:889-896.
7. Basta NE, Chao DL, Halloran ME, et al. Strategies for pandemic and seasonal infl uenza vaccination of schoolchildren in the United States. Am J Epidemiol. 2009;170:679-686.
8. Jordan R, Connock M, Albon E, et al. Universal vaccination of children against infl uenza: are there indirect benefi ts to the community? A systematic review of the evidence. Vaccine. 2006;24:1047-1062.
9. Ampofo WK, Baylor N, Cobey S, et al.; WHO Writing Group. Improving infl uenza vaccine virus selection. Report of a WHO informal consultation held at WHO headquarters, Geneva, Switzerland, 14-16 June 2010. Infl uenza Other Respi Viruses. 2012;6:142-152.
10. Ambrozaitis A, Groth N, Bugarini R, et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit infl uenza vaccine. Vaccine. 2009;27:6022-6029.
11. Barrett PN, Mundt W, Kistner O, et al. Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines. Expert Rev Vaccines. 2009;8:607-618.
12. Neuzil KM, Bright RA. Infl uenza vaccine manufacture: keeping up with change. J Infect Dis. 2009;200:835-837.
13. Ulmer JB, Valley U, Rappuoli R. Vaccine manufacturing: challenges and solutions. Nat Biotechnol. 2006;24:1377-1383.
14. Govorkova EA, Kodihalli S, Alymova IV, et al. Growth and immunogenicity of infl uenza viruses cultivated in Vero or MDCK cells and in embryonated chicken eggs. Dev Biol Stand. 1999;98:39-51; discussion 73.
15. Kessler N, Thomas-Roche G, Gérentes L, et al. Suitability of MDCK cells grown in a serum-free medium for infl uenza virus production. Dev Biol Stand. 1999;98:13-21; discussion 73.
16. Reisinger KS, Block SL, Izu A, et al. Subunit infl uenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis. 2009;200:849-857.
17. Frey S, Vesikari T, Szymczakiewicz-Multanowska A, et al. Clinical effi cacy of cell culture-derived and egg-derived inactivated subunit infl uenza vaccines in healthy adults. Clin Infect Dis. 2010;51:997-1004.
18. Groth N, Montomoli E, Gentile C, et al. Safety, tolerability and immunogenicity of a mammalian cell-culture-derived infl uenza vaccine: a sequential Phase I and Phase II clinical trial. Vaccine. 2009;27:786-791.
19. Szymczakiewicz-Multanowska A, Groth N, Bugarini R, et al. Safety and immunogenicity of a novel infl uenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009;200:841-848.
20. The Committee for Proprietary Medicinal Products (CHMP). Note for guidance on hamonisation of requirements for infl uenza vaccines. CHMP/BWP/214/96. Available at: http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003945.pdf. Accessed September 21, 2011.
21. Rowe T, Abernathy RA, Hu-Primmer J, et al. Detection of antibody to avian infl uenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol. 1999;37:937-943.
22. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-226.
23. Robertson JS. An overview of host cell selection. Dev Biol Stand. 1999;98:7-11; discussion 73.
24. Minor PD. Vaccines against seasonal and pandemic infl uenza and the implications of changes in substrates for virus production. Clin Infect Dis. 2010;50:560-565.
25. World Health Organization. Recommendations for infl uenza vaccine composition. February 28, 2003. Available at: http://www.who.int/infl uenza/vaccines/vaccinerecommendations1/en/index13.htm. Accessed September 21, 2011.