PAS abstracts for CAIV-T, with the numbers:
>>[1582] Efficacy and Safety of a Cold-Adapted, Live Attenuated, Trivalent Influenza Vaccine (CAIV-T) in Children Aged 6 to <36 Months Attending Day Care Centers in Europe and Israel
Timo Vesikari. Medical School, University of Tampere, Tampere, Finland; the CAIV-T Pediatric Day Care Efficacy Trial Network.
BACKGROUND: Children attending day care centers are at an increased risk of influenza. Intranasal CAIV-T could offer advantages over IM trivalent inactivated influenza vaccine in this setting.
OBJECTIVE: To determine CAIV-T efficacy, and safety over two consecutive influenza seasons against culture-confirmed influenza (A/H3N2, A/H1N1 and B) in children aged 6 to <36 months attending day care centers in Europe and Israel.
DESIGN/METHODS: In year one (Y1), 1784 healthy children aged 6 to <36 months attending day care were recruited from multiple sites in Belgium, Finland, Israel, Spain and the United Kingdom during Oct – Nov, 2000. Subjects were randomized in a 3:2 ratio to receive 2 intranasal doses of either CAIV-T or saline placebo prior to the first influenza season. In year 2 (Y2), , 1119 subjects received a single dose of either CAIV-T or saline placebo according to the original treatment group assignment. Active surveillance for protocol-defined influenza illness occurred weekly until May 2001 and May 2002, respectively. For each qualifying illness a nasal swab was obtained for influenza culture. Prospective pharmacoeconomic outcomes were assessed in Y1 and Y2.
RESULTS:
Efficacy of CAIV-T (Per Protocol) Against Influenza Illness Due to Subytpes Antigenically Similar to Vaccine Yr Influenza illness rate %Efficacy(95%CI)
CAIV-T Placebo
N n (%) N n (%)
1 951 15 (2) 665 72 (11) 85 (74, 92)
2 640 21 (3) 450 131 (29) 89 (82, 93)
N,Number of subjects in analysis.; n,Number (%) of subjects with culture-confirmed influenza illness.
Efficacy by antigenically similar strain: H1(92%, CI:81,97), B(73%, CI:39,89) in Y1; H1(90%, CI:56,99), H3 (90%, CI:83,95), B(82%, CI:54,94) in Y2. CAIV-T demonstrated significant protection against influenza-associated otitis media, days missed from day care, or parental work (Y1 and Y2), and medical visits, antibiotic or medication use(Y2). Safety: In 11d post dose 1 in Y1, the rate of CAIV-T vs placebo recipients experiencing runny nose was significantly higher (82 vs 75%, p=.001), but not after dosing in Y2, (67 vs 61%, p=.059). No differences in fever rates were observed after any dose.
CONCLUSIONS: CAIV-T was safe, immunogenic and efficacious and reduced influenza morbidity in children 6-<36mo attending day care.<<
>>[728] Efficacy and Safety of a Live Attenuated, Trivalent Influenza Vaccine (CAIV-T) in Children Living in South East Asia Against Community Acquired Culture-Confirmed Influenza
John Tam. The Pan-Asian CAIV-T Pediatric Efficacy Trial Netw; Wyeth Research; MedImmune.
BACKGROUND: Intranasal CAIV-T offers an attractive alternative to IM trivalent inactivated vaccine for pediatric influenza immunization.
OBJECTIVE: To determine the efficacy and safety of CAIV-T in children aged 12 to =36 mos. against culture-confirmed influenza.
DESIGN/METHODS: In year 1 (Y1), 3174 healthy children aged 12 to < 36 mos. at sites in China, Hong Kong, India, Malaysia, Philippines, Singapore, Taiwan, & Thailand were randomized 3:2, in Sep-Nov, 2000 to receive 2 intranasal doses of CAIV-T or placebo. In year 2 (Y2), all subjects were re-randomized to receive a single dose of CAIV-T or placebo. Active surveillance for influenza illness occurred through Nov 2001 and Oct 2002, respectively. For each qualifying illness, a nasal swab was obtained for influenza culture and typing.
RESULTS:
Efficacy of CAIV-T (Per Protocol) Against Influenza Illness Due to Subytpes Antigenically Similar to Vaccine Children dosed with: Children dosed with: Relative Efficacy (95%CI) In year
CAIV-T,Y1 vs. Placebo,Y1 73% (63,81) 1
CAIV-T,Y1 Placebo,Y2 vs. Placebo,Y1 Placebo,Y2 56% (31,73) 2
CAIV-T,Y1 CAIV-T,Y2 vs. CAIV-T,Y1 Placebo,Y2 64% (29,83) 2
CAIV-T,Y1 CAIV-T,Y2 vs. Placebo,Y1 Placebo,Y2 84% (70,92) 2
CAIV-T,Y1 CAIV-T,Y2 vs. Placebo,Y1 CAIV-T,Y2 61% (16,83) 2
Subjects received two doses of the indicated treatment in Y1 and a single dose in Y2. In placebo recipients influenza illness rate was 139/1111 (12.5%) in Y1; for subjects dosed with placebo both years, influenza illness rate was 49/494 (9.9%) in Y2
Protection against H1, H3, and B was demonstrated. After two doses of CAIV-T in year 1 followed by placebo in Y2, efficacy persisted for two years against matched strains. Two doses of CAIV-T in Y1 followed by one dose in Y2 provided optimal protection. Safety: In 11d post dose 1 in Y1, significantly more CAIV-T recipients experienced fever =37.5°C (22 vs 18%), runny nose/nasal congestion (62 vs 52%). decreased activity (13 vs 11%), decreased appetite (24 vs 20%)and use of fever medication(21 vs 18%). In 11d post dose in Y2, significantly more CAIV-T recipients experienced runny nose/nasal congestion (62 vs 55%), and fever medication use (18 vs 15%). Fever =40.0°C was infrequent (<0.5%) in all groups.
CONCLUSIONS: CAIV-T was safe and efficacious. Two doses of CAIV-T in Y1 followed by one dose in Y2 provided the best protection.<<
Sorry, fixed font won't do the job on the formatting. To see the tables properly, you're going to have to go fetch the abstracts yourself. You'll have to register. Start at Google with the keywords "annual meeting Pediatric Academic Societies" and surf from there to the abstract search engine. Then use "CAIV-T" as your keyword.
Cheers, Tuck |
