Comparison of immunogenicity and reactogenicity of split versus subunit influenza vaccine in Korean children aged 6-35 months

Yun Kyung Kim, Byung Wook Eun, Nam Hee Kim, Eun Kyeong Kang, Byung Sub Lee, Dong Ho Kim, Jung Sub Lim

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Studies comparing the immunogenicity and reactogenicity of trivalent inactivated subunit (SU) and split (SPL) vaccines in children in Asia are limited. In 2008, we assessed the safety and immunogenicity of SU and SPL influenza vaccines in Korean children aged 6-35 months. Methods: We studied 2 non-randomized cohorts of children who received either SU or SPL vaccine in an open-label non-stratified controlled trial at 6 hospitals in Korea. We measured antibody titers with a hemagglutination-inhibition assay at baseline and 30 days after the first or second flu shot. The primary goal was the determination of vaccine immunogenicity according to the European Union Committee of Human Medicinal Products licensing criteria. Results: Out of a total of 106 participants aged 6-35 months, 47 received the SPL vaccine and 59 the SU vaccine. After vaccination, 41 (87.2%), 40 (85.1%), and 33 (70.2%) of the 47 subjects in the SPL group had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. In the SU group, 42 (71.2%), 34 (57.6%), and 22 (37.3%) of 59 subjects had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. The post-vaccination geometric mean titers of H1N1, H3N2, and B (SPL vs SU) were 119.1, 99.8, and 61.4 vs 75.4, 51.2, and 24.1, respectively. There were no serious vaccine-related adverse events. There were no differences between the SPL and SU vaccines with respect to adverse events. Conclusions: The immunogenicity of the SPL vaccine appears to be better than that of the SU vaccine in children aged 6-35 months in Korea.

Original languageEnglish
Pages (from-to)460-468
Number of pages9
JournalScandinavian Journal of Infectious Diseases
Volume45
Issue number6
DOIs
Publication statusPublished - 2013 Jun 1

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Subunit Vaccines
Influenza Vaccines
Vaccines
Korea
Vaccination
Inactivated Vaccines
Hemagglutination
European Union
Licensure
Safety
Antibodies
Vaccine Immunogenicity

Keywords

  • Children
  • Immunogenicity
  • Influenza vaccine
  • Reactogenicity
  • Split vaccine
  • Subunit vaccine

ASJC Scopus subject areas

  • Medicine(all)
  • Immunology and Microbiology(all)
  • Microbiology (medical)
  • Infectious Diseases

Cite this

Comparison of immunogenicity and reactogenicity of split versus subunit influenza vaccine in Korean children aged 6-35 months. / Kim, Yun Kyung; Eun, Byung Wook; Kim, Nam Hee; Kang, Eun Kyeong; Lee, Byung Sub; Kim, Dong Ho; Lim, Jung Sub.

In: Scandinavian Journal of Infectious Diseases, Vol. 45, No. 6, 01.06.2013, p. 460-468.

Research output: Contribution to journalArticle

Kim, Yun Kyung ; Eun, Byung Wook ; Kim, Nam Hee ; Kang, Eun Kyeong ; Lee, Byung Sub ; Kim, Dong Ho ; Lim, Jung Sub. / Comparison of immunogenicity and reactogenicity of split versus subunit influenza vaccine in Korean children aged 6-35 months. In: Scandinavian Journal of Infectious Diseases. 2013 ; Vol. 45, No. 6. pp. 460-468.
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T1 - Comparison of immunogenicity and reactogenicity of split versus subunit influenza vaccine in Korean children aged 6-35 months

AU - Kim, Yun Kyung

AU - Eun, Byung Wook

AU - Kim, Nam Hee

AU - Kang, Eun Kyeong

AU - Lee, Byung Sub

AU - Kim, Dong Ho

AU - Lim, Jung Sub

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N2 - Background: Studies comparing the immunogenicity and reactogenicity of trivalent inactivated subunit (SU) and split (SPL) vaccines in children in Asia are limited. In 2008, we assessed the safety and immunogenicity of SU and SPL influenza vaccines in Korean children aged 6-35 months. Methods: We studied 2 non-randomized cohorts of children who received either SU or SPL vaccine in an open-label non-stratified controlled trial at 6 hospitals in Korea. We measured antibody titers with a hemagglutination-inhibition assay at baseline and 30 days after the first or second flu shot. The primary goal was the determination of vaccine immunogenicity according to the European Union Committee of Human Medicinal Products licensing criteria. Results: Out of a total of 106 participants aged 6-35 months, 47 received the SPL vaccine and 59 the SU vaccine. After vaccination, 41 (87.2%), 40 (85.1%), and 33 (70.2%) of the 47 subjects in the SPL group had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. In the SU group, 42 (71.2%), 34 (57.6%), and 22 (37.3%) of 59 subjects had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. The post-vaccination geometric mean titers of H1N1, H3N2, and B (SPL vs SU) were 119.1, 99.8, and 61.4 vs 75.4, 51.2, and 24.1, respectively. There were no serious vaccine-related adverse events. There were no differences between the SPL and SU vaccines with respect to adverse events. Conclusions: The immunogenicity of the SPL vaccine appears to be better than that of the SU vaccine in children aged 6-35 months in Korea.

AB - Background: Studies comparing the immunogenicity and reactogenicity of trivalent inactivated subunit (SU) and split (SPL) vaccines in children in Asia are limited. In 2008, we assessed the safety and immunogenicity of SU and SPL influenza vaccines in Korean children aged 6-35 months. Methods: We studied 2 non-randomized cohorts of children who received either SU or SPL vaccine in an open-label non-stratified controlled trial at 6 hospitals in Korea. We measured antibody titers with a hemagglutination-inhibition assay at baseline and 30 days after the first or second flu shot. The primary goal was the determination of vaccine immunogenicity according to the European Union Committee of Human Medicinal Products licensing criteria. Results: Out of a total of 106 participants aged 6-35 months, 47 received the SPL vaccine and 59 the SU vaccine. After vaccination, 41 (87.2%), 40 (85.1%), and 33 (70.2%) of the 47 subjects in the SPL group had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. In the SU group, 42 (71.2%), 34 (57.6%), and 22 (37.3%) of 59 subjects had titers ≥ 1:40 against H1N1, H3N2, and B, respectively. The post-vaccination geometric mean titers of H1N1, H3N2, and B (SPL vs SU) were 119.1, 99.8, and 61.4 vs 75.4, 51.2, and 24.1, respectively. There were no serious vaccine-related adverse events. There were no differences between the SPL and SU vaccines with respect to adverse events. Conclusions: The immunogenicity of the SPL vaccine appears to be better than that of the SU vaccine in children aged 6-35 months in Korea.

KW - Children

KW - Immunogenicity

KW - Influenza vaccine

KW - Reactogenicity

KW - Split vaccine

KW - Subunit vaccine

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