Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to <9 years of age: Safety and immunogenicity

Pediatric Infectious Disease Journal

Volumn 31, Issue 8, 2012, Pages 848-858

  Langley, Joanne M ^a   Reich, Dennis ^b   Aggarwal, Naresh ^c   Connor, David ^d   Lebel, Marc H ^e   Gupta, Anil ^f   Garfield, Hartley ^g   Li, Ping ^h   Madan, Anu ^h   Vaughn, David W ^h  

^a DALHOUSIE UNIVERSITY   (Canada)

^b Four Corners Walk In Clinic   (Canada)

^c Aggarwal and Associates Limited   (Canada)

^d Manitoba Clinic   (Canada)

^e UNIVERSITY OF MONTREAL   (Canada)

^f Albion Finch Medical Centre   (Canada)

^g HOSPITAL FOR SICK CHILDREN   (Canada)

^h GLAXOSMITHKLINE   (United States)

Author keywords

adjuvant; influenza vaccine; pandemic

Indexed keywords

AS 03; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; UNCLASSIFIED DRUG; VIRUS HEMAGGLUTININ;

2009 H1N1 INFLUENZA; ABDOMINAL ABSCESS; ANOREXIA; ANTIBODY RESPONSE; ARTICLE; BLOOD SAMPLING; CHILD; CONTROLLED STUDY; CONVULSION; COUGHING; DRUG SAFETY; EMULSION; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMAGGLUTINATION INHIBITION; HUMAN; IMMUNOGENICITY; INFANT; INFLUENZA VACCINATION; INJECTION SITE PAIN; IRRITABILITY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; SEROCONVERSION; SIDE EFFECT; SINGLE DRUG DOSE; TONSILLITIS; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ALPHA-TOCOPHEROL; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; DRUG COMBINATIONS; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; NEUTRALIZATION TESTS; PANDEMICS; POLYSORBATES; SQUALENE; TOCOPHEROLS; VACCINATION;

EID: 84863949910     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31825e6cd6     Document Type: Article

References (30)

1. Rennels MB, Meissner HC, Committee of Infectious Diseases. Reduction of influenza burden in children. American Academy of Pediatrics, Technical Report. Pediatric. 2002;110:e80. Available at: http://pediatrics. aappublications.org/ cgi/reprint/110/6/e80. Accessed July, 19, 2010.
2. Glass LM, Glass RJ. Social contact networks for the spread of pandemic influenza in children and teenagers. BMC Public Health. 2008;8:61.
3. Fiore AE, Shay DK, Broder K, et al. Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009;58(RR-8):1-52.
4. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. N Engl J Med. 2009;360:2605-2615.
5. Erratum in: N Engl J Med. 2009;361:102.
6. Domínguez-Cherit G, Lapinsky SE, Macias AE, et al. Critically ill patients with 2009 influenza A(H1N1) in Mexico. JAMA. 2009;302:1880-1887.
7. Centers for Disease Control and Prevention (CDC). 2009 Pandemic influenza A (H1N1) virus infections-Chicago, Illinois, April-July 2009. MMWR Morb Mortal Wkly Rep. 2009;58:913-918.
8. Centers for Disease Control and Prevention (CDC). 2009 H1N1-related deaths, hospitalizations and cases: details of extrapolations and ranges: United States, Emerging Infections Program (EIP) Data. April 15, 2010. Available at: http://www.cdc.gov/H1N1flu/pdf/Exact%20Numbers-March1. pdf. Accessed June 7, 2010.
9. Use of Influenza A (H1N1) 2009 Monovalent Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Morb Mortal Wkly Rep. 2009;58:1?8.
10. World Health Organization (WHO). Global Advisory Committee on Vaccine Safety, 16-17 June 2010. Wkly Epidemiol Rec. 2010;85:285?292.
11. Health Canada. Product Information Leaflet. Arepanrix. H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine. Available at: http://www. hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/ prodinfo-vaccin-eng.php. Accessed June 7, 2010.
12. Hehme NW, Künzel W, Petschke F, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Invest. 2002;22:751?769.
13. Leroux-Roels I, Bernhard R, Gérard P, et al. Broad clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One. 2008;3:e1665.
14. Baras B, de Waal L, Stittelaar KJ, et al. Pandemic H1N1 vaccine requires the use of an adjuvant to protect against challenge in naïve ferrets. Vaccine. 2011;29:2120-2126.
15. Reed LT, Muench H. A simple method of calculating fifty percent end point. Am J Hyg. 1938;27:493-498.
16. European Committee for Proprietary Medicinal Products (CHMP). Guideline on influenza vaccine prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context (EMEA/CHMP/VWP/263499/2006). European Agency for the Evaluation of Medicinal Products, 24 January, 2007.
17. Guidance document on the use of pandemic influenza A (H1N1) 2009 inactivated monovalent vaccine. Available at: http://www.phac-aspc.gc.ca/alert- alerte/h1n1/vacc/monovacc/immuno-eng.php. Accessed October 7, 2010.
18. Jefferson T, Rivetti A, Harnden A, et al. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008;:CD004879.
19. Zhu FC, Wang H, Fang HH, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009;361:2414-2423.
20. NIH Bulletin. Updated results: In youngest children, a second dose of 2009 H1N1 influenza vaccine elicits robust immune response. Available at: http://www3.niaid.nih.gov/news/newsreleases/2009/interimpedsdata.htm. Accessed May 10, 2010.
21. Plennevaux E, Sheldon E, Blatter M, et al. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010;375:41-48.
22. Liang XF, Wang HQ, Wang JZ, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010;375:56-66.
23. Carmona A, Oménaca F, Tejedor JC, et al. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010;28:5837?5844.
24. Waddington CS, Walker WT, Oeser C, 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.
25. Vesikari T, Pellegrini M, Karvonen A, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009;28:563?571.
26. Ruben FL. Inactivated influenza virus vaccines in children. Clin Infect Dis. 2004;38:678-688.
27. Neuzil KM, Dupont WD, Wright PF, et al. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J. 2001;20:733-740.
28. US Food and Drug Administration (FDA) Guidance for Industry. Clinical data needed to support the licensure of pandemic influenza vaccines. US Food and Drug Administration May 2007. Available at: http://www.fda.gov/cber/gdlns/ panfluvac.htm. Accessed January 5, 2010.
29. Van Buynder PG, Dhaliwal JK, Van Buynder JL, et al. Protective effect of single-dose adjuvanted pandemic influenza vaccine in children. Influenza Other Respi Viruses. 2010;4:171-178.
30. Schwarz TF, Horacek T, Knuf M, et al. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine. 2009;27:6284-6290.