A Reduced Dose Whole Virion Aluminum Adjuvanted Seasonal Influenza Vaccine Is Immunogenic, Safe, and Well Tolerated in Pediatric Patients.
BACKGROUND
Data suggest that pediatric patients might react differently to influenza vaccination, both in terms of immunity and side effects. We have recently shown that using a whole virion vaccine with aluminum phosphate adjuvants, reduced dose vaccines containing 6 µg of viral hemagglutinin (HA) per strain are immunogenic, and well tolerated in adult and elderly patients. Here we show the results of a multicenter clinical trial of pediatric patients, using reduced doses of a new, whole virion, aluminum phosphate adjuvanted vaccine (FluArt, Budapest, Hungary).


METHODS
A total of 120 healthy volunteers were included in two age groups (3-11 years, receiving 3 µg of HA per strain, and 12-18 years, receiving 6 µg of HA per strain). We used hemagglutination inhibition testing to assess immunogenicity, based on EMA and FDA licensing criteria, including post/pre-vaccination geometric mean titer ratios, seroconversion and seropositivity rates. Safety and tolerability were assessed using CHMP guidelines.


RESULTS
All subjects entered the study and were vaccinated (ITT population). All 120 subjects attended the control visit on Day 21 (PP population). All immunogenicity licensing criteria were met in both age groups for all three vaccine virus strains. No serious adverse events were detected and the vaccine was well tolerated by both age groups.


DISCUSSION
Using a whole virion vaccine and aluminum phosphate adjuvants, a reduction in the amount of the viral hemmaglutinin is possible while maintaining immunogenicity, safety and tolerability in pediatric and adolescent patients.
['Vajo|Zoltan|Z|0000-0003-1049-1694', 'Balaton|Gergely|G|', 'Vajo|Peter|P|', 'Torzsa|Peter|P|']
D000276:Adjuvants, Immunologic D000293:Adolescent D017607:Aluminum Compounds D002648:Child D002675:Child, Preschool D005260:Female D006801:Humans D006814:Hungary D053118:Influenza A Virus, H1N1 Subtype D053122:Influenza A Virus, H3N2 Subtype D009981:Influenza B virus D007252:Influenza Vaccines D007251:Influenza, Human D008297:Male D010710:Phosphates D011446:Prospective Studies D014771:Virion
influenza vaccine immunogenicity children reactogenity