Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence.
Pediatrics
; 126(4): e762-70, 2010 Oct.
Article
in En
| MEDLINE
| ID: mdl-20819892
ABSTRACT
OBJECTIVE:
This study evaluated the immunogenicity, safety, and tolerability of a MF59-adjuvanted H5N1 vaccine in a population 6 months through 17 years of age.METHODS:
Healthy subjects 6 to <36 months, 3 to <9 months, and 9 to <18 years of age were assigned randomly to receive 2 doses of either a MF59-adjuvanted H5N1 vaccine (7.5 µg/dose) or a MF59-adjuvanted trivalent seasonal influenza control vaccine (15 µg/dose for each antigen). Immunogenicity against the A/Vietnam/1194/2004-like vaccine strain was measured before and 3 weeks after the 2-dose primary series, through hemagglutination inhibition (HI), single radial hemolysis (SRH), and microneutralization. Local and systemic reactions were recorded.RESULTS:
A total of 335 subjects received the H5N1 vaccine, and 137 subjects received the seasonal vaccine. Rates of seroprotection (HI titer of ≥40) against the H5N1 vaccine antigen were 97% for children 6 to 36 months and 3 to 9 years of age and 89% for older children. All subjects seroconverted in the SRH assay. Microneutralization titers of ≥40 were achieved by 99% of subjects, and ≥98% of subjects, respectively. Local reactions, particularly injection site pain in older children, were common, generally mild to moderate in nature, and transient and resolved spontaneously. Up to 5% of participants. There were no vaccine-related serious adverse events in either group.CONCLUSIONS:
In this pediatric population, MF59-adjuvanted H5N1 vaccine was highly immunogenic, had a good safety profile, reactogenicity comparable with that of an adjuvanted seasonal influenza control vaccine.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Squalene
/
Influenza Vaccines
/
Adjuvants, Immunologic
/
Immunization
/
Influenza, Human
/
Influenza A Virus, H5N1 Subtype
Type of study:
Clinical_trials
Limits:
Adolescent
/
Child
/
Child, preschool
/
Humans
/
Infant
Language:
En
Journal:
Pediatrics
Year:
2010
Document type:
Article
Affiliation country:
Finlandia