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Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial.
Vaccine. 2010 Aug 16; 28(36):5857-63.V

Abstract

This study was conducted to determine the immunogenicity and safety of an inactivated split-virus influenza A/H1N1 vaccine in healthy Korean children from 6 months to <18 years of age. The immunization schedule consisted of two vaccinations, 21 days apart. The unadjuvanted vaccine contained 7.5microg (subjects 6 months to <3 years of age) or 15microg (subjects 3 to <18 years of age) of hemagglutinin antigen per dose. A total of 251 subjects were enrolled and 248 and 242 subjects, respectively, were included in the post-first dose and post-second dose immunogenicity evaluations conducted on a per protocol basis. By day 21, after the first dose, hemagglutination-inhibition titers of 1:40 or more were observed in 5.9% of subjects 6 months to <3 years of age, 34.9% of subjects 3 to <9 years of age and 81.4% of subjects 9-18 years of age. By day 21 after the second dose, the titer had been achieved 55.9%, 69.5% and 90.5%, respectively. No vaccination-related serious adverse events were observed. A single 15-microg dose of vaccine was highly immunogenic in subjects equal to or more than 9 years of age. However, a two-dose regimen is needed to produce potentially protective antibody titers in younger children.

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Authors+Show Affiliations

Oh CE
Department of Pediatrics, Seoul National University Children's Hospital, Seoul, Republic of Korea.
Lee J
No affiliation info available
Kang JH
No affiliation info available
Hong YJ
No affiliation info available
Kim YK
No affiliation info available
Cheong HJ
No affiliation info available
Ahn YJ
No affiliation info available
Kim SH
No affiliation info available
Lee HJ
No affiliation info available

MeSH

AdolescentAntibodies, ViralChildChild, PreschoolFemaleHemagglutination Inhibition TestsHemagglutinin Glycoproteins, Influenza VirusHumansImmunization ScheduleInfantInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesInfluenza, HumanMaleProspective StudiesRepublic of KoreaVaccines, Inactivated

Pub Type(s)

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

Language

eng

PubMed ID

20600483

Citation

Oh, Chi-Eun, et al. "Safety and Immunogenicity of an Inactivated Split-virus Influenza A/H1N1 Vaccine in Healthy Children From 6 Months to <18 Years of Age: a Prospective, Open-label, Multi-center Trial." Vaccine, vol. 28, no. 36, 2010, pp. 5857-63.
Oh CE, Lee J, Kang JH, et al. Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial. Vaccine. 2010;28(36):5857-63.
Oh, C. E., Lee, J., Kang, J. H., Hong, Y. J., Kim, Y. K., Cheong, H. J., Ahn, Y. J., Kim, S. H., & Lee, H. J. (2010). Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial. Vaccine, 28(36), 5857-63. https://doi.org/10.1016/j.vaccine.2010.06.060
Oh CE, et al. Safety and Immunogenicity of an Inactivated Split-virus Influenza A/H1N1 Vaccine in Healthy Children From 6 Months to <18 Years of Age: a Prospective, Open-label, Multi-center Trial. Vaccine. 2010 Aug 16;28(36):5857-63. PubMed PMID: 20600483.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial. AU - Oh,Chi-Eun, AU - Lee,Jina, AU - Kang,Jin-Han, AU - Hong,Young-Jin, AU - Kim,Yun-Kyung, AU - Cheong,Hee-Jin, AU - Ahn,Young-Joo, AU - Kim,Sang-Hoon, AU - Lee,Hoan-Jong, Y1 - 2010/06/30/ PY - 2010/02/10/received PY - 2010/06/12/revised PY - 2010/06/18/accepted PY - 2010/7/6/entrez PY - 2010/7/6/pubmed PY - 2010/11/16/medline SP - 5857 EP - 63 JF - Vaccine JO - Vaccine VL - 28 IS - 36 N2 - This study was conducted to determine the immunogenicity and safety of an inactivated split-virus influenza A/H1N1 vaccine in healthy Korean children from 6 months to <18 years of age. The immunization schedule consisted of two vaccinations, 21 days apart. The unadjuvanted vaccine contained 7.5microg (subjects 6 months to <3 years of age) or 15microg (subjects 3 to <18 years of age) of hemagglutinin antigen per dose. A total of 251 subjects were enrolled and 248 and 242 subjects, respectively, were included in the post-first dose and post-second dose immunogenicity evaluations conducted on a per protocol basis. By day 21, after the first dose, hemagglutination-inhibition titers of 1:40 or more were observed in 5.9% of subjects 6 months to <3 years of age, 34.9% of subjects 3 to <9 years of age and 81.4% of subjects 9-18 years of age. By day 21 after the second dose, the titer had been achieved 55.9%, 69.5% and 90.5%, respectively. No vaccination-related serious adverse events were observed. A single 15-microg dose of vaccine was highly immunogenic in subjects equal to or more than 9 years of age. However, a two-dose regimen is needed to produce potentially protective antibody titers in younger children. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20600483/Safety_and_immunogenicity_of_an_inactivated_split_virus_influenza_A/H1N1_vaccine_in_healthy_children_from_6_months_to_<18_years_of_age:_a_prospective_open_label_multi_center_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)00882-0 DB - PRIME DP - Unbound Medicine ER -