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Trivalent and quadrivalent MF59(®)-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study
Giovanni Della Cioppa1, Timo Vesikari, Etienne Sokal
1Vaccines Development, Novartis Vaccines and Diagnostics, Siena, Italy. giovanni.della cioppa@novartis.com
Insights
Adjuvanted quadrivalent influenza vaccines (QIV) show promising safety and immunogenicity in young children. MF59 adjuvant boosts antibody responses, offering potential advantages for pediatric influenza protection.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Young children face high risks of influenza infection and complications.
- Conventional trivalent inactivated influenza vaccines (TIV) offer suboptimal protection in this age group, especially against influenza B strains.
Purpose of the Study:
- To evaluate the safety and immunogenicity of adjuvanted (ATIV) and non-adjuvanted trivalent (TIV) and quadrivalent (QIV) influenza vaccines.
- To assess different vaccine combinations in healthy children aged 6 to <36 months.
Main Methods:
- A dose-ranging, factorial design trial involving 480 healthy children.
- Administration of various combinations of adjuvanted and non-adjuvanted TIV and QIV.
- Assessment of safety, tolerability, and immunogenicity through antibody response measurements.
Main Results:
- The addition of a second B strain to TIV was immunogenic and did not impact the immunogenicity of other strains.
- MF59 adjuvant significantly enhanced immune responses, with elevated antibodies observed even after a single dose.
- A dose-response relationship was noted between antibody response and MF59 adjuvant presence.
- No specific safety or tolerability patterns were associated with different adjuvant/antigen doses or the inclusion of a second B strain.
Conclusions:
- MF59-adjuvanted quadrivalent influenza vaccine (QIV) demonstrates potential benefits for enhancing influenza protection in young children.
- Adjuvanted QIV may offer improved immunogenicity and antibody responses compared to conventional vaccines in the pediatric population.
Abstract:
Young children are at increased risk for influenza infections and related complications. The protection offered to children by conventional trivalent inactivated influenza vaccines (TIV) is suboptimal, due to poor immunogenicity and a higher exposure to infection and complications in this age group, particularly from influenza B strains. In this dose-ranging, factorial design trial, we report the safety and immunogenicity of different combinations of adjuvanted (ATIV) and non-adjuvanted trivalent (TIV) and quadrivalent (QIV) influenza vaccines in 480 healthy children 6 to <36 months of age. The results show that the second B strain added to TIV was immunogenic and did not affect immunogenicity of the other strains. The addition of the MF59(®) adjuvant promoted robust immune responses with notable elevations in antibodies observed even after one dose. A dose-response relationship was observed between the antibody response and MF59 adjuvant. No patterns in safety and tolerability emerged with different adjuvant and antigen doses nor with the addition of a second B strain. MF59-adjuvanted QIV offers potential advantages to young children.
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