tetano
Editor, Senior Moderator
J Infect Dis. 2014 Oct 6. pii: jiu548. [Epub ahead of print]
AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase II/III randomized, placebo-controlled, observer-blind trial.
Kosalaraksa P1, Jeanfreau R2, Frenette L3, Drame M4, Madariaga M4, Innis BL4, Godeaux O5, Izurieta P5, Vaughn DW6.
Author information
Abstract
Background. This phase II/III, randomized, placebo-controlled, observer-blinded study (www.ClinicalTrials.gov; NCT01310413) assessed the immunogenicity, reactogenicity, and safety of an inactivated, split virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years.
METHODS:
Children received two influenza vaccine doses 21 days apart, each containing 1.9 ?g of hemagglutinin and AS03B adjuvant (5.93 mg of α-tocopherol). Randomization was 8:3 for vaccine to placebo, with equal allocation between three age strata (6-35 months, 3-8 years, 9-17 years). Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees, at Day 182 for half of them and at Day 385 for the remaining half. Reactogenicity after each dose and safety up to 1-year post-vaccination were evaluated.
RESULTS:
Within each age stratum, lower limit of the 98.3% confidence interval (CI) for the Day 42 seroprotection rate was ≥70% thus fulfilling the United States and European licensure criteria. The immune responses elicited by vaccine persisted well above baseline for 1 year. The vaccine was more reactogenic than placebo, but no major safety concerns were identified.
CONCLUSIONS:
AS03B-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied.
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
PMID:
25293368
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25293368
AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase II/III randomized, placebo-controlled, observer-blind trial.
Kosalaraksa P1, Jeanfreau R2, Frenette L3, Drame M4, Madariaga M4, Innis BL4, Godeaux O5, Izurieta P5, Vaughn DW6.
Author information
Abstract
Background. This phase II/III, randomized, placebo-controlled, observer-blinded study (www.ClinicalTrials.gov; NCT01310413) assessed the immunogenicity, reactogenicity, and safety of an inactivated, split virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years.
METHODS:
Children received two influenza vaccine doses 21 days apart, each containing 1.9 ?g of hemagglutinin and AS03B adjuvant (5.93 mg of α-tocopherol). Randomization was 8:3 for vaccine to placebo, with equal allocation between three age strata (6-35 months, 3-8 years, 9-17 years). Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees, at Day 182 for half of them and at Day 385 for the remaining half. Reactogenicity after each dose and safety up to 1-year post-vaccination were evaluated.
RESULTS:
Within each age stratum, lower limit of the 98.3% confidence interval (CI) for the Day 42 seroprotection rate was ≥70% thus fulfilling the United States and European licensure criteria. The immune responses elicited by vaccine persisted well above baseline for 1 year. The vaccine was more reactogenic than placebo, but no major safety concerns were identified.
CONCLUSIONS:
AS03B-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied.
? The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
PMID:
25293368
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25293368