Assessment of squalene adjuvanted and non-adjuvanted vaccines against pandemic H1N1 influenza in children 6 mo to 17 y of age

Human Vaccines and Immunotherapeutics

Volumn 8, Issue 9, 2012, Pages 1283-1292

  Vesikari, Timo ^a   Pepin, Stéphanie ^b   Kusters, Inca ^b   Hoffenbach, Agnès ^b   Denis, Martine ^b  

^a TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^b SANOFI PASTEUR   (France)

Author keywords

Adjuvant; Children; Clinical trial; H1N1; Immunogenicity; Influenza; Pandemic; Persistence

Indexed keywords

IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; SQUALENE;

2009 H1N1 INFLUENZA; ADOLESCENT; ANOREXIA; ANTIBODY TITER; ARTICLE; CHILD; CONTROLLED STUDY; CRYING; DOSE RESPONSE; DROWSINESS; DRUG DOSAGE FORM COMPARISON; DRUG FEVER; DRUG FORMULATION; DRUG INDUCED HEADACHE; ECCHYMOSIS; HEMAGGLUTINATION INHIBITION; HUMAN; IMMUNITY; IMMUNOGENICITY; INFANT; INFLUENZA VACCINATION; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; IRRITABILITY; MALAISE; MULTICENTER STUDY; MYALGIA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SHIVERING; SIDE EFFECT; VOMITING;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; PANDEMICS; SQUALENE;

EID: 84867003398     PISSN: None     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.21265     Document Type: Article

References (30)

1. World Health Organization. Pandemic (H1N1) 2009 - update 68. (Accessed October 9, 2009 at http://www.who.int/csr/don/2009-10-02/en/index.html)
2. Chowell G, Bertozzi SM, Colchero MA, Lopez-Gatell H, Alpuche-Aranda C, Hernandez M, et al. Severe respiratory disease concurrent with the circulation of H1N1 influenza. N Engl J Med 2009; 361:674-9; PMID:19564633; http://dx.doi.org/10.1056/NEJMoa0904023.
3. Centers for Disease Control and Prevention (CDC). Surveillance for pediatric deaths associated with 2009 pandemic influenza A (H1N1) virus infection - United States, April-August 2009. MMWR Morb Mortal Wkly Rep 2009; 58:941-7; PMID:19730406.
4. Vaillant L, La Ruche G, Tarantola A, Barboza P; epidemic intelligence team at InVS. Epidemiology of fatal cases associated with pandemic H1N1 influenza 2009. Euro Surveill 2009; 14:19309; PMID:19712643.
5. Shinde V, Bridges CB, Uyeki TM, Shu B, Balish A, Xu X, et al. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. N Engl J Med 2009; 360:2616-25; PMID:19423871; http://dx.doi.org/10. 1056/NEJMoa0903812.
6. Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, et al.; Novel Influenza A (H1N1) Pregnancy Working Group. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet 2009; 374:451-8; PMID:19643469; http://dx.doi.org/10.1016/S0140-6736(09)61304-0.
7. Perez-Padilla R, de la Rosa-Zamboni D, Ponce de Leon S, Hernandez M, Quiñones-Falconi F, Bautista E, et al.; INER Working Group on Influenza. Pneumonia and respiratory failure from swine-origin influenza A (H1N1) in Mexico. N Engl J Med 2009; 361:680-9; PMID:19564631; http://dx.doi.org/10.1056/ NEJMoa0904252.
8. Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, et al. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis 2008; 198:642-9; PMID:18576945; http://dx.doi.org/10.1086/590913.
9. Nolan T, Richmond PC, Formica NT, Höschler K, Skeljo MV, Stoney T, et al. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine 2008; 26:6383-91; PMID:18801398; http://dx.doi.org/10.1016/j.vaccine.2008.08.046.
10. Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, et al. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One 2009; 4:e4384; PMID:19197383; http://dx.doi.org/10.1371/journal.pone.0004384.
11. Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, et al. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics 2010; 126:e762-70; PMID:20819892; http://dx.doi.org/10.1542/peds.2009-2628.
12. Frey S, Poland G, Percell S, Podda A. Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults. Vaccine 2003; 21:4234-7; PMID:14505903; http://dx.doi.org/10.1016/S0264-410X(03)00456-0.
13. Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J 2009; 28:563-71; PMID:19561422; http://dx.doi.org/10.1097/INF.0b013e31819d6394.
14. Garten RJ, Davis CT, Russell CA, Shu B, Lindstrom S, Balish A, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009; 325:197-201; PMID:19465683; http://dx.doi.org/10.1126/science.1176225.
15. World Health Organization. Characteristics of the emergent influenza A (H1N1) viruses and recommendations for vaccine development. May 26 2009. (Accessed September 23, 2009, at http://www.who.int/csr/resources/publications/ swineflu/H1N1Vaccinevirusrecommendation26May2009.pdf)
16. Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009; 361:1945-52; PMID:19745214; http://dx.doi.org/10.1056/ NEJMoa0906453.
17. Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, et al. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA 2010; 303:37-46; PMID:20026597; http://dx.doi.org/10.1001/jama.2009.1911.
18. Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, et al.; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin 2011; 7:58-66; PMID:21285531; http://dx.doi.org/10.4161/hv. 7.1.13411.
19. Zhu F-C, Wang H, Fang H-H, Yang JG, Lin XJ, Liang XF, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med 2009; 361:2414-23; PMID:19846844; http://dx.doi.org/10.1056/NEJMoa0908535.
20. Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, et al. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine 2011; 29:1569-75; PMID:21219979; http://dx.doi.org/10.1016/j.vaccine.2010.12.116.
21. Roman F, Vaman T, Kafeja F, Hanon E, Van Damme P. AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin Infect Dis 2010; 51:668-77; PMID:20687838; http://dx.doi.org/10.1086/655830.
22. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009; 361:2424-35; PMID:19745215; http://dx.doi.org/10.1056/NEJMoa0907650.
23. Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, et al. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ 2010; 340:c2649; PMID:20508026; http://dx.doi.org/10.1136/bmj.c2649.
24. Carmona A, Omeñaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, et al. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine 2010; 28:5837-44; PMID:20600478; http://dx.doi.org/10.1016/j.vaccine.2010.06.065.
25. Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, et al. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine 2011; 29:4353-61; PMID:21504774; http://dx.doi.org/10.1016/j.vaccine.2011.04.011.
26. Nassim C, Christensen S, Henry D, Holmes S, Hohenboken M, Kanesa-Thasan N. Identification of antigen and adjuvant doses resulting in optimal immunogenicity and antibody persistence up to 1 year after immunization with a pandemic A/H1N1 influenza vaccine in children 3 to < 9 years of age. Pediatr Infect Dis J 2012; 31:e59-65; PMID:22418661; http://dx.doi.org/10.1097/INF. 0b013e31824b9545.
27. The World Health Organization (WHO). WHO Manual on Animal Influenza Diagnosis and Surveillance. 2002. Accessed October 21, 2009 at http://www.who.int/vaccine-research/diseases/influenza/WHO-manual-on-animal- diagnosis-and-surveillance-2002-5.pdf
28. Kendal AP, Pereira MS, Skehel JJ, eds. Concepts and Procedures for Laboratory-Based Influenza Surveillance. Atlanta, GA: Centers for Disease Control and Prevention; 1982.
29. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines. CPMP/BWP/214/96. The European Agency for the Evaluation of Medicinal Products (EMEA), March 1997. (Accessed September 25, 2009, at http://www.emea.europa.eu/pdfs/human/bwp/ 021496en.pdf)
30. FDA Guidance for Industry. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. September 2007. Accessed October 15, 2009 at http://www.fda.gov/downloads/ BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/ Vaccines/ucm091977.pdf