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Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children.
Hum Vaccin Immunother. 2015; 11(2):358-76.HV

Abstract

Mass immunization of children has the potential to decrease infection rates and prevent the transmission of influenza. We evaluated the immunogenicity, safety, and tolerability of different formulations of cell-derived MF59-adjuvanted and nonadjuvanted A/H1N1 influenza vaccine in children and adolescents. This was a randomized, single-blind, multicenter study with a total of 666 healthy subjects aged 6 months-17 y in one of 3 vaccination groups, each receiving formulations containing different amounts of influenza A/H1N1 antigen with or without MF59. A booster trivalent seasonal MF59 vaccine was administered one year after primary vaccinations. Antibody titers were assessed by hemagglutination inhibition (HI) and microneutralization assays obtained on days 1, 22, 43, 366, and 387 (3 weeks post booster). Safety was monitored throughout the study. One vaccination with 3.75 μg of A/H1N1 antigen formulated with 50% MF59 (3.75_halfMF59) or 7.5 μg of A/H1N1 antigen formulated with 100% MF59 (7.5_fullMF59) induced an HI titer ≥1:40 in >70% of children in the 1-<3, 3-8, and 9-17 y cohorts; however, 2 vaccinations with nonadjuvanted 15 μg A/H1N1 antigen were needed to achieve this response in the 1-<3 and 3-8 y cohorts. Among children aged 6-11 months, 1 dose of 7.5_fullMF59 resulted in an HI titer ≥1:40 in >70% while 2 doses of 3.75_halfMF59 were required to achieve this result. All vaccines were well tolerated. Our findings support the immunogenicity and safety of the 3.75_halfMF59 (2 doses for children <12 months) and 7.5_fullMF59 vaccine formulations for use in children and adolescents aged 6 months to 17 y The use of the 3.75_halfMF59 could have the benefit of antigen and adjuvant sparing, increasing the available vaccine doses allowing vaccination of more people.

Authors+Show Affiliations

a Clinic for Children and Youth; Dr. Horst Schmidt Clinics ; Wiesbaden , Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25621884

Citation

Knuf, Markus, et al. "Immunogenicity and Safety of Cell-derived MF59®-adjuvanted A/H1N1 Influenza Vaccine for Children." Human Vaccines & Immunotherapeutics, vol. 11, no. 2, 2015, pp. 358-76.
Knuf M, Leroux-Roels G, Rümke H, et al. Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358-76.
Knuf, M., Leroux-Roels, G., Rümke, H., Rivera, L., Pedotti, P., Arora, A. K., Lattanzi, M., Kieninger, D., & Cioppa, G. D. (2015). Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children. Human Vaccines & Immunotherapeutics, 11(2), 358-76. https://doi.org/10.4161/21645515.2014.987014
Knuf M, et al. Immunogenicity and Safety of Cell-derived MF59®-adjuvanted A/H1N1 Influenza Vaccine for Children. Hum Vaccin Immunother. 2015;11(2):358-76. PubMed PMID: 25621884.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children. AU - Knuf,Markus, AU - Leroux-Roels,Geert, AU - Rümke,Hans, AU - Rivera,Luis, AU - Pedotti,Paola, AU - Arora,Ashwani Kumar, AU - Lattanzi,Maria, AU - Kieninger,Dorothee, AU - Cioppa,Giovanni Della, PY - 2015/1/27/entrez PY - 2015/1/27/pubmed PY - 2015/12/17/medline KW - AE, adverse event KW - CHMP, European Committee for Medicinal Products for Human Use KW - CI, confidence interval KW - GMR, geometric mean ratio KW - GMT, geometric mean titer KW - H1N1 KW - HI, hemagglutination inhibition KW - MF59 KW - MN, microneutralization KW - PPS, per-protocol set KW - SAE, serious adverse event KW - WHO, World Health Organization KW - adjuvant KW - cell-culture KW - pandemic KW - pediatric SP - 358 EP - 76 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 11 IS - 2 N2 - Mass immunization of children has the potential to decrease infection rates and prevent the transmission of influenza. We evaluated the immunogenicity, safety, and tolerability of different formulations of cell-derived MF59-adjuvanted and nonadjuvanted A/H1N1 influenza vaccine in children and adolescents. This was a randomized, single-blind, multicenter study with a total of 666 healthy subjects aged 6 months-17 y in one of 3 vaccination groups, each receiving formulations containing different amounts of influenza A/H1N1 antigen with or without MF59. A booster trivalent seasonal MF59 vaccine was administered one year after primary vaccinations. Antibody titers were assessed by hemagglutination inhibition (HI) and microneutralization assays obtained on days 1, 22, 43, 366, and 387 (3 weeks post booster). Safety was monitored throughout the study. One vaccination with 3.75 μg of A/H1N1 antigen formulated with 50% MF59 (3.75_halfMF59) or 7.5 μg of A/H1N1 antigen formulated with 100% MF59 (7.5_fullMF59) induced an HI titer ≥1:40 in >70% of children in the 1-<3, 3-8, and 9-17 y cohorts; however, 2 vaccinations with nonadjuvanted 15 μg A/H1N1 antigen were needed to achieve this response in the 1-<3 and 3-8 y cohorts. Among children aged 6-11 months, 1 dose of 7.5_fullMF59 resulted in an HI titer ≥1:40 in >70% while 2 doses of 3.75_halfMF59 were required to achieve this result. All vaccines were well tolerated. Our findings support the immunogenicity and safety of the 3.75_halfMF59 (2 doses for children <12 months) and 7.5_fullMF59 vaccine formulations for use in children and adolescents aged 6 months to 17 y The use of the 3.75_halfMF59 could have the benefit of antigen and adjuvant sparing, increasing the available vaccine doses allowing vaccination of more people. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/25621884/Immunogenicity_and_safety_of_cell_derived_MF59®_adjuvanted_A/H1N1_influenza_vaccine_for_children_ L2 - https://www.tandfonline.com/doi/full/10.4161/21645515.2014.987014 DB - PRIME DP - Unbound Medicine ER -