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Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age.
Vaccine. 2015 Jan 01; 33(1):174-81.V

Abstract

OBJECTIVES

This study was designed to identify the optimal dose of an MF59-adjuvanted, monovalent, A/H1N1 influenza vaccine in healthy paediatric subjects.

METHODS

Subjects aged 3-8 years (n=194) and 9-17 years (n=160) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 μg antigen with half a standard dose of MF59 adjuvant, 7.5 μg antigen with a full dose of MF59, or (children 3-8 years only), a non-adjuvanted 15 μg formulation. A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming. Immunogenicity was assessed by haemagglutination inhibition (HI) and microneutralization assays. Vaccine safety was assessed throughout the study (up to 18 months).

RESULTS

A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines (HI titres ≥1:40>70%; seroconversion>40%; and GMR>2.5). Two non-adjuvanted vaccine doses were required to meet the same licensure criteria. After first and second doses, percentage of subjects with HI titres ≥1:40 were between 97% and 100% in the adjuvanted vaccine groups compared with 68% and 91% in the non-adjuvanted group, respectively. Postvaccination seroconversion rates ranged from 91% to 98% in adjuvanted groups and were 68% (first dose) and 98% (second dose) in the non-adjuvanted group. HI titres ≥1:330 after primary doses were achieved in 69% to 90% in adjuvanted groups compared with 41% in the non-adjuvanted group. Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups. All A/H1N1 vaccine formulations were generally well tolerated. No vaccine-related serious adverse events occurred, and no subjects were withdrawn from the study due to an adverse event.

CONCLUSIONS

An MF59-adjuvanted influenza vaccine containing 3.75 μg of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old.

Authors+Show Affiliations

Zentrum für Kinder-und Jugendmedizin, Universitätsmedizin, Mainz, Germany.Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium.Vaxinostics BV, University Vaccine Center Rotterdam Nijmegen, Rotterdam, The Netherlands.Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.Hospital Maternidad Ntra Sra. de la Altagracia, Gazcue, Santo Domingo, The Dominican Republic.Novartis Vaccines and Diagnostics S.r.l., Siena, Italy. Electronic address: maria.lattanzi@novartis.com.Novartis Vaccines and Diagnostics S.r.l., Siena, Italy.Novartis Vaccines and Diagnostics S.r.l., Siena, Italy.Zentrum für Kinder-und Jugendmedizin, Universitätsmedizin, Mainz, Germany.Novartis Vaccines and Diagnostics S.r.l., Siena, Italy.

Pub Type(s)

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

Language

eng

PubMed ID

25444803

Citation

Knuf, Markus, et al. "Safety and Immunogenicity of an MF59-adjuvanted A/H1N1 Pandemic Influenza Vaccine in Children From Three to Seventeen Years of Age." Vaccine, vol. 33, no. 1, 2015, pp. 174-81.
Knuf M, Leroux-Roels G, Rümke HC, et al. Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. Vaccine. 2015;33(1):174-81.
Knuf, M., Leroux-Roels, G., Rümke, H. C., Abarca, K., Rivera, L., Lattanzi, M., Pedotti, P., Arora, A., Kieninger-Baum, D., & Della Cioppa, G. (2015). Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. Vaccine, 33(1), 174-81. https://doi.org/10.1016/j.vaccine.2014.10.085
Knuf M, et al. Safety and Immunogenicity of an MF59-adjuvanted A/H1N1 Pandemic Influenza Vaccine in Children From Three to Seventeen Years of Age. Vaccine. 2015 Jan 1;33(1):174-81. PubMed PMID: 25444803.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. AU - Knuf,Markus, AU - Leroux-Roels,Geert, AU - Rümke,Hans C, AU - Abarca,Katia, AU - Rivera,Luis, AU - Lattanzi,Maria, AU - Pedotti,Paola, AU - Arora,Ashwani, AU - Kieninger-Baum,Dorothee, AU - Della Cioppa,Giovanni, Y1 - 2014/11/11/ PY - 2014/03/24/received PY - 2014/10/21/revised PY - 2014/10/30/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/7/22/medline KW - A/H1N1 KW - MF59 KW - Paediatric KW - Pandemic influenza KW - Vaccine KW - www.clinicaltrials.gov (NCT00971542) SP - 174 EP - 81 JF - Vaccine JO - Vaccine VL - 33 IS - 1 N2 - OBJECTIVES: This study was designed to identify the optimal dose of an MF59-adjuvanted, monovalent, A/H1N1 influenza vaccine in healthy paediatric subjects. METHODS: Subjects aged 3-8 years (n=194) and 9-17 years (n=160) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 μg antigen with half a standard dose of MF59 adjuvant, 7.5 μg antigen with a full dose of MF59, or (children 3-8 years only), a non-adjuvanted 15 μg formulation. A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming. Immunogenicity was assessed by haemagglutination inhibition (HI) and microneutralization assays. Vaccine safety was assessed throughout the study (up to 18 months). RESULTS: A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines (HI titres ≥1:40>70%; seroconversion>40%; and GMR>2.5). Two non-adjuvanted vaccine doses were required to meet the same licensure criteria. After first and second doses, percentage of subjects with HI titres ≥1:40 were between 97% and 100% in the adjuvanted vaccine groups compared with 68% and 91% in the non-adjuvanted group, respectively. Postvaccination seroconversion rates ranged from 91% to 98% in adjuvanted groups and were 68% (first dose) and 98% (second dose) in the non-adjuvanted group. HI titres ≥1:330 after primary doses were achieved in 69% to 90% in adjuvanted groups compared with 41% in the non-adjuvanted group. Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups. All A/H1N1 vaccine formulations were generally well tolerated. No vaccine-related serious adverse events occurred, and no subjects were withdrawn from the study due to an adverse event. CONCLUSIONS: An MF59-adjuvanted influenza vaccine containing 3.75 μg of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25444803/Safety_and_immunogenicity_of_an_MF59_adjuvanted_A/H1N1_pandemic_influenza_vaccine_in_children_from_three_to_seventeen_years_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(14)01504-7 DB - PRIME DP - Unbound Medicine ER -