tetano
Editor, Senior Moderator
Vaccine. 2013 Oct 10. pii: S0264-410X(13)01358-3. doi: 10.1016/j.vaccine.2013.09.074. [Epub ahead of print]
Immunogenicity and safety of Fluzone? intradermal and high-dose influenza vaccines in older adults ≥65 years of age: A randomized, controlled, phase II trial.
Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, Diazgranados C, Landolfi V.
Source
Sanofi Pasteur, Discovery Drive, Swiftwater, PA 18372, USA. Electronic address: peter.tsang@SanofiPasteur.com.
Abstract
We conducted a randomized, controlled, multicenter, phase II study to evaluate the immunogenicity and safety of an investigational intradermal (ID) trivalent influenza vaccine (TIV) and a high-dose (HD) intramuscular (IM) TIV in older adults (≥65 years of age). Older adult subjects were immunized with ID vaccine containing either 15μg hemagglutinin (HA)/strain (n=636) or 21μg HA/strain (n=634), with HD IM vaccine containing 60μg HA/strain (n=320), or with standard-dose (SD) IM vaccine (Fluzone?; 15μg HA/strain; n=319). For comparison, younger adults (18-49 years of age) were immunized with SD IM vaccine. In older adults, post-vaccination geometric mean titers induced by the ID vaccines were superior to those induced by the SD IM vaccine for the A/H1N1 and A/H3N2 strains and non-inferior for the B strain. Seroconversion rates induced by the ID vaccines were superior to those induced by the SD IM vaccine in older adults for the A/H1N1 and B strains and non-inferior for the A/H3N2 strain. Results did not differ significantly for the two ID vaccine dosages. Post-vaccination geometric mean titers, seroconversion rates, and most seroprotection rates were significantly higher in HD vaccine recipients than in older adult recipients of the SD IM or ID vaccines and, for most measures, were comparable to those of younger adult SD IM vaccine recipients. Injection-site reactions, but not systemic reactions or unsolicited adverse events, were more common with the ID vaccines than with the IM vaccines. No treatment-related serious adverse events were reported. This study demonstrated that: (1) the ID and HD vaccines were well-tolerated and more immunogenic than the SD IM vaccine in older adults; (2) the HD vaccine was more immunogenic than the ID vaccines in older adults; and (3) the HD vaccine in older adults and the SD IM vaccine in younger adults elicited comparable antibody responses (ClinicalTrials.gov identifier no.: NCT00551031).
Copyright ? 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
AE, Antibodies, CI, GMT, HA, HD, HI, High-dose vaccine, ID, IM, Intradermal, Older adults, SD, Safety, Trivalent influenza vaccine, adverse event, confidence interval, geometric mean titer, hemagglutination inhibition, hemagglutinin, high-dose inactivated trivalent influenza vaccine (60μg HA/strain) for the intramuscular route, intradermal, intramuscular, standard-dose inactivated trivalent influenza vaccine (15μg HA/strain) for the intramuscular route
PMID:
24120672
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24120672
Immunogenicity and safety of Fluzone? intradermal and high-dose influenza vaccines in older adults ≥65 years of age: A randomized, controlled, phase II trial.
Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, Diazgranados C, Landolfi V.
Source
Sanofi Pasteur, Discovery Drive, Swiftwater, PA 18372, USA. Electronic address: peter.tsang@SanofiPasteur.com.
Abstract
We conducted a randomized, controlled, multicenter, phase II study to evaluate the immunogenicity and safety of an investigational intradermal (ID) trivalent influenza vaccine (TIV) and a high-dose (HD) intramuscular (IM) TIV in older adults (≥65 years of age). Older adult subjects were immunized with ID vaccine containing either 15μg hemagglutinin (HA)/strain (n=636) or 21μg HA/strain (n=634), with HD IM vaccine containing 60μg HA/strain (n=320), or with standard-dose (SD) IM vaccine (Fluzone?; 15μg HA/strain; n=319). For comparison, younger adults (18-49 years of age) were immunized with SD IM vaccine. In older adults, post-vaccination geometric mean titers induced by the ID vaccines were superior to those induced by the SD IM vaccine for the A/H1N1 and A/H3N2 strains and non-inferior for the B strain. Seroconversion rates induced by the ID vaccines were superior to those induced by the SD IM vaccine in older adults for the A/H1N1 and B strains and non-inferior for the A/H3N2 strain. Results did not differ significantly for the two ID vaccine dosages. Post-vaccination geometric mean titers, seroconversion rates, and most seroprotection rates were significantly higher in HD vaccine recipients than in older adult recipients of the SD IM or ID vaccines and, for most measures, were comparable to those of younger adult SD IM vaccine recipients. Injection-site reactions, but not systemic reactions or unsolicited adverse events, were more common with the ID vaccines than with the IM vaccines. No treatment-related serious adverse events were reported. This study demonstrated that: (1) the ID and HD vaccines were well-tolerated and more immunogenic than the SD IM vaccine in older adults; (2) the HD vaccine was more immunogenic than the ID vaccines in older adults; and (3) the HD vaccine in older adults and the SD IM vaccine in younger adults elicited comparable antibody responses (ClinicalTrials.gov identifier no.: NCT00551031).
Copyright ? 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
AE, Antibodies, CI, GMT, HA, HD, HI, High-dose vaccine, ID, IM, Intradermal, Older adults, SD, Safety, Trivalent influenza vaccine, adverse event, confidence interval, geometric mean titer, hemagglutination inhibition, hemagglutinin, high-dose inactivated trivalent influenza vaccine (60μg HA/strain) for the intramuscular route, intradermal, intramuscular, standard-dose inactivated trivalent influenza vaccine (15μg HA/strain) for the intramuscular route
PMID:
24120672
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24120672