Live attenuated influenza vaccine, trivalent, is safe in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a community-based, nonrandomized, open-label trial

Pediatrics

Volumn 116, Issue 3, 2005, Pages

  Piedra, Pedro A ^a   Gaglani, Manjusha J ^b   Riggs, Mark ^b   Herschler, Gayla ^b   Fewlass, Charles ^b   Watts, Matt ^b   Kozinetz, Claudia ^a   Hessel, Colin ^c   Glezen, W Paul ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

^c MEDIMMUNE   (United States)

Author keywords

Asthma exacerbation; Children and adolescents; Health service utilization; Influenza vaccine; Outcome assessment

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; INFLUENZA VACCINE; LIVE VACCINE; MEASLES MUMPS RUBELLA VACCINE; TRIPLE VACCINE;

ACUTE RESPIRATORY TRACT DISEASE; ADOLESCENT; ADULT; ARTICLE; ASTHMA; CHILD; COMMUNITY CARE; CONTROLLED STUDY; DOSE RESPONSE; DRUG SAFETY; HEALTH CARE UTILIZATION; HUMAN; HUMAN EXPERIMENT; LOWER RESPIRATORY TRACT INFECTION; MEDICAL RECORD; OTITIS MEDIA; PRIORITY JOURNAL; SINUSITIS; UNSPECIFIED SIDE EFFECT; VACCINATION; CLINICAL TRIAL; HEALTH SERVICE; INFANT; INFLUENZA; INTRANASAL DRUG ADMINISTRATION; PRESCHOOL CHILD; UTILIZATION REVIEW;

ADMINISTRATION, INTRANASAL; ADOLESCENT; CHILD; CHILD, PRESCHOOL; HEALTH SERVICES; HUMANS; INFANT; INFLUENZA VACCINES; INFLUENZA, HUMAN;

EID: 28844458591     PISSN: 00314005     EISSN: 00314005     Source Type: Journal    
DOI: 10.1542/peds.2004-2258     Document Type: Article

References (50)

1. Michaud CM, Murray CJL, Bloom BR. Burden of disease - implications for future research. JAMA. 2001;285:535-539
2. Glezen WP, Paredes A, Taber LH. Influenza in children. Relationship to other respiratory agents. JAMA. 1980;243:1345-1349
3. Sugaya N, Mitamura K, Nirasawa M, Takahashi K. The impact of winter epidemics of influenza and respiratory syncytial virus on paediatric admissions to an urban general hospital. J Med Virol. 2000;60:102-106
4. Chiu SS, Lau YL, Chan KH, Wong WHS, Peiris JSM. Influenza-related hospitalizations among children in Hong Kong. N Engl J Med. 2002;347:2097-2103
5. Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA. 1999;282:1440-1446
6. Izurieta HS, Thompson WW, Kramarz P, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med. 2000;342:232-239
7. Neuzil KM, Mellen BG, Wright PF, Mitchel EF, Griffin MR. The effects of influenza on hospitalization, outpatient visits, and courses of antibiotics in children. N Engl J Med. 2000;342:225-231
8. Glezen WP, Decker M, Joseph SW, Mercready RG Jr. Acute respiratory disease associated with influenza epidemic in Houston, 1981-1983. J Infect Dis. 1987;155:1119-1126
9. Couch RB, Kasel JA, Glezen WP, et al. Influenza: its control in persons and populations. J Infect Dis. 1986;153:431-440
10. Jennings LC, Miles JAR. A study of acute respiratory disease in the community of Port Chalmers. II. Influenza A/Port Chalmers/1/73: intrafamilial spread and the effect of antibodies to the surface antigens. J Hyg (Lond). 1978;81:67-75
11. Fox JP, Hall CE, Cooney MK, Foy HM. Influenzavirus infections in Seattle families, 1975-1979. I. Study design, methods, and the occurrence of infections by time and age. Am J Epidemiol. 1982;116:212-227
12. Fox JP, Cooney MK, Hall CE, Foy HM. Influenzavirus infections in Seattle families, 1975-1979. II. Pattern of infection in invaded households and relation of age and prior antibody to occurrence of infection and related illness. Am J Epidemiol. 1982;116:228-242
13. Frank AL, Taber LH, Wells JM. Comparison of infection rates and severity of illness for influenza A subtypes H1N1 and H3N2. J Infect Dis. 1985;151:73-80
14. Glezen WP, Taber LH, Frank AL, Gruber WC, Piedra PA. Influenza virus infection in infants. Pediatr Infect Dis J. 1997;16:1065-1068
15. Neuzil KM, Hohlbein C, Zhu Y. Illness among schoolchildren during influenza season. Arch Pediatr Adolesc Med. 2002;156:986-991
16. Neuzil KM, Wright PF, Mitchel EF, Griffin MR. The burden of influenza illness in children with asthma and other chronic medical conditions. J Pediatr. 2000;137:856-864
17. Glezen WP, Greenberg SB, Atmar RL, Piedra PA, Couch RB. Impact of respiratory virus infections on persons with chronic underlying conditions JAMA. 2000;283:499-505
18. Sperber SJ, Gross PA. Influenza: manifestations, treatment and prevention. Infect Med. 1994;11:675-683
19. Glezen WP. Consideration of the risk of influenza in children and indications for prophylaxis. Rev Infect Dis. 1980;2:408-420
20. O'Brien KL, Walters MI, Sellman J, et al. Severe pneumococcal pneumonia in previously healthy children: the role of preceding influenza infection. Clin Infect Dis. 2000;30:784-789
21. Fujimoto S, Kobayashi M, Uemura O, et al. PCR on cerebrospinal fluid to show influenza-associated acute encephalopathy or encephalitis. Lancet. 1998;352:873-875
22. McCullers JA, Facchini S, Chesney PJ, Webster RG. Influenza B virus encephalitis. Clin Infect Dis. 1999;28:898-900
23. Centers for Disease Control and Prevention (CDC). Update: influenza-associated deaths reported among children aged <18 years - United States, 2003-04 influenza season. MMWR Morb Mortal Wkly Rep. 2004;52:1286-1288
24. Belshe RB, Mendelman P, Treanor J, et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998;338:1405-1412
25. Belshe RB, Gruber WC, Mendelman P, et al. Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine. J Pediatr. 2000;136:168-175
26. Piedra PA, Yan L, Kotloff K, et al. Safety of the trivalent, cold-adapted influenza vaccine (CAIV-T) in preschool aged children. Pediatrics. 2002;110:662-672
27. Bergen R, Black S, Shinefield H, et al. Safety of cold-adapted live attenuated influenza vaccine in a large cohort of children and adolescents. Pediatr Infect Dis J. 2004;23:138-144
28. Piedra PA, Gaglani M, Herschler G, et al. Safety and effectiveness of the trivalent, cold-adapted influenza vaccine (CAIV-T) in children. In: Osterhaus ADME, ed. The World Congress on Options for the Control of Influenza IV. Amsterdam, Netherlands: Elsevier Science 2001;1219:939-943
29. Halloran ME, Longini IM, Gaglani MJ, et al. Protection against influenza A (H1N1) and B by trivalent, cold-adapted, influenza virus vaccine (CAIV-T). Am J Epidemiol. 2003;158:305-311
30. Gaglani MJ, Piedra PA, Herschler GB, et al. Direct effectiveness of the trivalent, cold-adapted, influenza virus vaccine (CAIV-T) against the 2000-2001 influenza A (H1N1) and B epidemic in healthy children. Arch Pediatr Adolesc Med. 2004;158:65-73
31. Griffin MR, Taylor JA, Daugherty JR, Ray WA. No increased risk for invasive bacterial infection found following diphtheria-tetanus-pertussis immunization. Pediatrics. 1992;89:640-642
32. Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W. Risk of seizure after measles-mumps-rubella immunization. Pediatrics. 1991;88:881-885
33. Selvin S. Poisson regression analysis. In: Selvin S, ed. Practical Biostatistical Methods. Belmont, CA: Duxbury Press; 1995
34. Ledley FD, Brody B, Kozinetz CA, Mize S. The challenge of follow-up for clinical trials of somatic gene therapy. Hum Gene Ther. 1992;3:657-663
35. Breslow N. Multivariate cohort analysis. Natl Cancer Inst Monogr. 1985;67:149-156
36. Whitaker-Dowling P, Maassab HF, Younger JS. Dominant-negative mutants as antiviral agents: simultaneous infection with the cold-adapted live-attenuated vaccine for influenza A protects ferrets from disease produced by wild-type influenza A. J Infect Dis. 1991;164:1200-1202
37. Younger JS, Treanor JJ, Betts RF, Whitaker-Dowling P. Effect of simultaneous administration of cold-adapted and wild-type influenza A viruses on experimental wild-type influenza infection in humans. J Clin Microbiol. 1994;32:750-754
38. Maassab HF. Adaptation and growth characteristics of influenza virus at 25°C. Nature. 1967;213:612-614
39. Maassab HF, DeBorde DC. Development and characterization of coldadapted viruses for use as live virus vaccines. Vaccine. 1985;3:355-369
40. Snyder MH, Betts RF, DeBorde DC, et al. Four viral genes independently contribute to attenuation of live A/Ann Arbor/6/60 (H2N2) cold-adapted reassortant virus vaccine. J Virol. 1988;62:488-495
41. Donabedian AM, DeBorde DC, Cook S, Smitka CW, Maassab HF. A mutation in the PA protein gene of cold-adapted B/Ann Arbor/1/66 influenza virus associated with reversion of temperature sensitivity and attenuated virulence. Virology. 1988;163:444-451
42. Shu LP, Sharp GB, Lin YP, et al. Genetic reassortment in pandemic and interpandemic influenza viruses. A study of 122 viruses infecting humans. Eur J Epidemiol. 1996;12:63-70
43. Xu X, Smith CB, Mungall BA, et al. Intercontinental circulation of human influenza A (H1N2) reassortant viruses during the 2001-2002 influenza season. J Infect Dis. 2002;186:1490-1493
44. Ellis JS, Alvarez-Aguero A, Gregory V, Lin YP, Hay A, Zambon MC. Influenza AH1N2 viruses, United Kingdom, 2001-02 influenza season. Emerg Infect Dis. 2003;9:304-310
45. Glezen WP, Piedra PA, Longini I, Halloran ME. Safety of cold-adapted live influenza vaccine [letter to editor]. Pediatr Infect Dis J. 2004;23:593-594
46. Zangwill KM, Droge J, Mendelman P, et al. Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among children. Pediatr Infect Dis J. 2001;20:740-746
47. Nolan T, Lee M-S, Cordova JM, et al. Safety and immunogenicity of a live-attenuated influenza vaccine blended and filled at two manufacturing facilities. Vaccine. 2003;21:1224-1231
48. Piedra PA. Safety of the trivalent, cold-adapted influenza vaccine (CAIV-T) in children. Semin Pediatr Infect Dis. 2002;13:90-96
49. Redding G, Walker RE, Hessel C, et al. Safety and tolerability of cold-adapted influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J. 2002;21:44-48
50. Gaglani MJ, Piedra PA, Riggs MW, Herschler GB, Griffith ME, Glezen WP. Safety of the trivalent, cold-adapted, influenza virus vaccine (CAIV-T) in a subgroup of children with history of mild intermittent wheezing/asthma/reactive airway disease (RAD) in a community-based, non-randomized, open-label trial [Abstract 2437]. Pediatr Res. 2001;49:242A