Safety and tolerability of cold-adapted influenza vaccine, trivalent, in infants younger than 6 months of Age

Pediatrics

Volumn 121, Issue 3, 2008, Pages

  Vesikari, Timo ^a   Karvonen, Aino ^a   Smith, Helen M ^b   Dunning, Andrew ^c   Razmpour, Ahmad ^c   Saville, Melanie K ^b   Gruber, William C ^c   Forest, Bruce D ^c  

^a TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^b Wyeth Vaccines Research   (United Kingdom)

^c WYETH RESEARCH   (United States)

Author keywords

Clinical trial; Immunoqenicity; Infants; Live attenuated influenza vaccine

Indexed keywords

CAIV T; COLD ADAPTED INFLUENZA VACCINE; INFLUENZA VACCINE; PLACEBO; UNCLASSIFIED DRUG; LIVE VACCINE;

ARTICLE; BODY DISCOMFORT; BRONCHITIS; BRONCHOSPASM; CLINICAL TRIAL; CONJUNCTIVITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; FINLAND; HIGH RISK PATIENT; HUMAN; HUMAN EXPERIMENT; INFANT; INFANT DISEASE; INFECTION PREVENTION; INFLUENZA; MALE; NORMAL HUMAN; NOSE CONGESTION; OTITIS MEDIA; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINORRHEA; TOOTH DISEASE; UPPER RESPIRATORY TRACT INFECTION; AGE; COLD; DRUG TOXICITY; FOLLOW UP; IMMUNIZATION; INTRANASAL DRUG ADMINISTRATION; METHODOLOGY; PROBABILITY; REFERENCE VALUE; RISK ASSESSMENT; VACCINATION;

ADMINISTRATION, INTRANASAL; AGE FACTORS; COLD; DOUBLE-BLIND METHOD; DRUG TOXICITY; FEMALE; FINLAND; FOLLOW-UP STUDIES; HUMANS; IMMUNIZATION SCHEDULE; INFANT; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; PROBABILITY; REFERENCE VALUES; RISK ASSESSMENT; VACCINATION; VACCINES, ATTENUATED;

EID: 40949141949     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2007-1405     Document Type: Article

References (22)

1. Neuzil KM, Mellen BG, Wright PF, Mitchel EF Jr, Griffin MR. The effect of influenza on hospitalizations, outpatient visits, and courses of antibiotics in children. N Engl J Med. 2000; 342(4):225-231
2. Heikkinen T, Silvennoinen H, Peltola V, et al. Burden of influenza in children in the community. J Infect Dis. 2004;190(8): 1369-1373
3. oughlin J, Poulios N, Napalkov P, Wegmuller Y, Monto AS. A study of influenza and influenza-related complications among children in a large US health insurance plan database. Phar-macoeconomics. 2003;21 (4):273-283
4. O'Brien MA, Uyeki TM, Shay DK, et al. Incidence of outpatient visits and hospitalizations related to influenza in infants and young children. Pediatrics. 2004;113(3 pt l):585-593
5. Principi N, Esposito S, Marchisio P, Gasparini R, Crovari P. Socioeconomic impact of influenza on healthy children and their families. Pediatr Infect Dis J. 2003;22(10 suppl):S207-S210
6. Quach C, Piche-Walker L, Piatt R, Moore D. Risk factors associated with severe influenza infections in childhood: implication for vaccine strategy. Pediatrics. 2003;112(3). Available at: www.pediatrics.org/cgi/content/ full/112/3/eI97
7. Advisory Committee on Immunization Practices; Smith NM, Bresee JS, et al. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP) [published correction appears in MMWR Morb Mortal Wkly Rep. 2006;55(29):800j. MMWR Recomm Rep. 2006; 55(RR-I0):I-42
8. American Academy of Pediatrics, Committee on Infectious Diseases. Recommendations for influenza immunization of children. Pediatrics. 2004;113(5):1441-1447
9. Ashkenazi S, Vertruyen A, Aŕistegui J, et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr Inf Dis J. 2006;25(]0): 870-879
10. Vesikari T, Fleming DM, Aristegui JF, et al. Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care. Pediatrics. 2006; 118(6): 2298-2312
11. Belshe RB, Edwards KM, Vesikari T, et al. Comparative safety and efficacy of live attenuated and inactivated influenza vaccines in infants and young children. N Engl J Med. 2007;356(7): 685-696
12. Frank AL, Taber LH, Wells CR, et al. Patterns of shedding of myxoviruses and paramyxoviruses in children. J Infect Dis. 1981;144(5):433-441
13. Hall CB, Douglas RG Jr, Geiman JM, Meagher MP. Viral shedding patterns of children with influenza B infection. J Infect Dis. 1979;140(4):610-613
14. Long CE, Hall CB, Cunningham CK, et al. Influenza surveillance in community-dwelling elderly compared with children. Arch Earn Med. 1997;6(5):459-465
15. Wright PF, Ross KB, Thompson J, Karzon DT. Influenza A infections in young children: primary natural infection and protective efficacy of live-vaccine-induced or naturally acquired immunity. N Engl J Med. 1977;296(15):829-834
16. Vesikari T, Karvonen A, Korhonen T, et al. A randomized, double-blind study of the safety, transmissibility and pheno-typic and genotypic stability of cold-adapted influenza virus vaccine. Pediatr Infect Dis J. 2006;25(7):590-595
17. World Health Organization (WHO). Recommended composition of influenza virus vaccines for use in the 2001-2002 season. Wkly Epidemiol Sec. 2001;76(8):58-61
18. Belshe RB, Mendelman PM, Treanor J, et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine in children. N Engl J Med. 1998;338(20):1405-1412
19. Tarn JS, Capeding MRZ, Lum LCS, et al. Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia. Pediatr Infect Dis J. 2007;26(7):619-628
20. Piedra PA, Yan L, Kotloff K, et al. Safety of the trivalent, cold-adapted influenza vaccine in preschool-aged children. Pediatrics. 2002; 110(4):662-672
21. Belshe RB, Gruber WC, Mendelman PM, 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(2):168-175
22. Nichol KL, Mendelman PM, Mallon KP, et al. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA. 1999; 282(2):1 37-144