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MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications.
Int J Infect Dis. 2019 Aug; 85S:S18-S25.IJ

Abstract

OBJECTIVE

To assess the safety and immunogenicity of the MF59-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad) in children aged 6 months through 5 years who are at risk of influenza complications.

METHODS

A retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated dataset from six randomized clinical studies that compared aIIV3 with non-adjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised 10 784 children, of whom 373 (3%) were at risk of influenza complications.

RESULTS

The at-risk safety population comprised 373 children aged 6 months through 5 years: 179 received aIIV3 and 194 received non-adjuvanted IIV3 (128 subjects received a licensed IIV3). The most important risk factors were respiratory system illnesses (62-70%) and infectious and parasitic diseases (33-39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk children and 55% of healthy children who received aIIV3; of those receiving licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited AE. The most common AEs were infections, including upper respiratory tract infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 participants from one study), geometric mean titers (GMTs) were approximately 2- to 3-fold higher with aIIV3 than with IIV3 for all three homologous strains (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79-96%) and IIV3 (83-89%).

CONCLUSIONS

In young children at risk of influenza complications, aIIV3 was well-tolerated and had a safety profile that was generally similar to that of non-adjuvanted IIV3. Similar to the not-at-risk population, the immune response in at-risk subjects receiving aIIV3 was increased over those receiving IIV3, suggesting aIIV3 is a valuable option in young children at risk of influenza complications.

Authors+Show Affiliations

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.Seqirus Netherlands BV, Amsterdam, The Netherlands.Seqirus Netherlands BV, Amsterdam, The Netherlands. Electronic address: janine.oberye@seqirus.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31051279

Citation

Patel, Sanjay S., et al. "MF59-adjuvanted Seasonal Trivalent Inactivated Influenza Vaccine: Safety and Immunogenicity in Young Children at Risk of Influenza Complications." International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, vol. 85S, 2019, pp. S18-S25.
Patel SS, Bizjajeva S, Heijnen E, et al. MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications. Int J Infect Dis. 2019;85S:S18-S25.
Patel, S. S., Bizjajeva, S., Heijnen, E., & Oberye, J. (2019). MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications. International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, 85S, S18-S25. https://doi.org/10.1016/j.ijid.2019.04.023
Patel SS, et al. MF59-adjuvanted Seasonal Trivalent Inactivated Influenza Vaccine: Safety and Immunogenicity in Young Children at Risk of Influenza Complications. Int J Infect Dis. 2019;85S:S18-S25. PubMed PMID: 31051279.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications. AU - Patel,Sanjay S, AU - Bizjajeva,Svetlana, AU - Heijnen,Esther, AU - Oberye,Janine, Y1 - 2019/04/30/ PY - 2019/02/16/received PY - 2019/04/22/revised PY - 2019/04/24/accepted PY - 2019/5/6/pubmed PY - 2019/10/28/medline PY - 2019/5/4/entrez KW - Adjuvant KW - Children KW - Influenza KW - MF59 KW - Risk of influenza complications KW - Vaccine SP - S18 EP - S25 JF - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JO - Int J Infect Dis VL - 85S N2 - OBJECTIVE: To assess the safety and immunogenicity of the MF59-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad) in children aged 6 months through 5 years who are at risk of influenza complications. METHODS: A retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated dataset from six randomized clinical studies that compared aIIV3 with non-adjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised 10 784 children, of whom 373 (3%) were at risk of influenza complications. RESULTS: The at-risk safety population comprised 373 children aged 6 months through 5 years: 179 received aIIV3 and 194 received non-adjuvanted IIV3 (128 subjects received a licensed IIV3). The most important risk factors were respiratory system illnesses (62-70%) and infectious and parasitic diseases (33-39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk children and 55% of healthy children who received aIIV3; of those receiving licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited AE. The most common AEs were infections, including upper respiratory tract infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 participants from one study), geometric mean titers (GMTs) were approximately 2- to 3-fold higher with aIIV3 than with IIV3 for all three homologous strains (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79-96%) and IIV3 (83-89%). CONCLUSIONS: In young children at risk of influenza complications, aIIV3 was well-tolerated and had a safety profile that was generally similar to that of non-adjuvanted IIV3. Similar to the not-at-risk population, the immune response in at-risk subjects receiving aIIV3 was increased over those receiving IIV3, suggesting aIIV3 is a valuable option in young children at risk of influenza complications. SN - 1878-3511 UR - https://www.unboundmedicine.com/medline/citation/31051279/MF59_adjuvanted_seasonal_trivalent_inactivated_influenza_vaccine:_Safety_and_immunogenicity_in_young_children_at_risk_of_influenza_complications_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1201-9712(19)30194-8 DB - PRIME DP - Unbound Medicine ER -