tetano
Editor, Senior Moderator
J Infect Dis. 2013 Sep 16. [Epub ahead of print]
Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in a Pediatric Population.
van der Velden MV, Fritz R, P?llabauer EM, Portsmouth D, Howard MK, Kreil TR, Dvorak T, Fritsch S, Vesikari T, Diez-Domingo J, Richmond P, Lee BW, Kistner O, Ehrlich HJ, Barrett PN, Aichinger G.
Source
Vaccine R&D, Baxter BioScience, Vienna, Austria.
Abstract
Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines which are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years were randomized to receive two immunizations with a 7.5 ?g or 3.75 ?g hemagglutinin (HA) dose of a non-adjuvanted whole-virus A/Vietnam strain H5N1 vaccine; adolescents aged 9-17 years received a 7.5 ?g dose only. A subset of participants received a booster immunization with an A/Indonesia strain H5N1 vaccine approximately one year later. HA and neuraminidase antibody responses were assessed.Results. Vaccination was safe and well-tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5 ?g dose of A/Vietnam vaccine induced virus neutralization (MN) titers ≥1:20 against the A/Vietnam strain in 68.8% to 85.4% of participants in the different age groups. After the booster, 93.1% to 100% of participants achieved MN titers ≥1:20 against the A/Vietnam and A/Indonesia strains. NA-inhibiting antibodies were induced in ≥90% of participants after two immunizations with the 7.5 ?g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus H5N1 vaccine is suitable for pre-pandemic or pandemic immunization in a pediatric population.Clinical Trial Registration. ClinicalTrials.gov.NCT01052402.
PMID:
24041789
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24041789
Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in a Pediatric Population.
van der Velden MV, Fritz R, P?llabauer EM, Portsmouth D, Howard MK, Kreil TR, Dvorak T, Fritsch S, Vesikari T, Diez-Domingo J, Richmond P, Lee BW, Kistner O, Ehrlich HJ, Barrett PN, Aichinger G.
Source
Vaccine R&D, Baxter BioScience, Vienna, Austria.
Abstract
Background. Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines which are safe and effective in the pediatric population.Methods. Infants and children aged 6-35 months and 3-8 years were randomized to receive two immunizations with a 7.5 ?g or 3.75 ?g hemagglutinin (HA) dose of a non-adjuvanted whole-virus A/Vietnam strain H5N1 vaccine; adolescents aged 9-17 years received a 7.5 ?g dose only. A subset of participants received a booster immunization with an A/Indonesia strain H5N1 vaccine approximately one year later. HA and neuraminidase antibody responses were assessed.Results. Vaccination was safe and well-tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5 ?g dose of A/Vietnam vaccine induced virus neutralization (MN) titers ≥1:20 against the A/Vietnam strain in 68.8% to 85.4% of participants in the different age groups. After the booster, 93.1% to 100% of participants achieved MN titers ≥1:20 against the A/Vietnam and A/Indonesia strains. NA-inhibiting antibodies were induced in ≥90% of participants after two immunizations with the 7.5 ?g A/Vietnam vaccine and in 100% of participants after the booster.Conclusions. A whole-virus H5N1 vaccine is suitable for pre-pandemic or pandemic immunization in a pediatric population.Clinical Trial Registration. ClinicalTrials.gov.NCT01052402.
PMID:
24041789
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24041789