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Cited by 14Influenza Virus Research StudiesBacterial Infections and VaccinesImmunotherapy and Immune Responses

The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.

Immunogenicity and Safety of AS03-adjuvanted H5N1 Influenza Vaccine in Children 6–35 Months of Age: Results From a Phase 2, Randomized, Observer-blind, Multicenter, Dose-ranging Study

Open access
Kim, Joon Hyung, Drame, Mamadou, Puthanakit, Thanyawee, Chiu, Nan-Chang, Supparatpinyo, Khuanchai, Huang, Li-Min, Chiu, Cheng-Hsun, Chen, Po-Yen, Hwang, Kao-Pin, Danier, Jasur, Friel, Damien, Salaun, Bruno, Woo, Wayne, Vaughn, David W., Innis, Bruce, Schuind, Anne·2021·Pediatric Infectious Disease Journal
DOI 10.1097/inf.0000000000003247PMC PMC8357047
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Abstract

Background: This phase 2 observer-blind, randomized, multicenter, dose-ranging study evaluated immunogenicity and safety of different formulations of an AS03-adjuvanted H5N1 influenza vaccine in children 6–35 months of age. Methods: One hundred eighty-five children randomized into 5 groups [1.9 µg hemagglutinin (HA)/AS03 B, 0.9 µg HA/AS03 C, 1.9 µg HA/AS03 C, 3.75 µg HA/AS03 C or 3.75 µg HA/AS03 D] were to receive 2 doses administered 21 days apart (primary vaccination). AS03 was classified by amount of DL-α-tocopherol, with AS03 B the highest amount. One year later, all subjects were to receive unadjuvanted 3.75 µg HA as antigen challenge. Immunogenicity was assessed 21 days after primary vaccination (day 42) and 7 days after antigen challenge (day 392). Immunogenicity-fever index, based on hemagglutination inhibition and microneutralization antibody titers at day 42 and fever 7 days after each vaccination, was used to guide the selection of an acceptable formulation. Results: After primary vaccination, formulations elicited strong homologous immune responses with all subjects’ hemagglutination inhibition titers ≥1:40 post-vaccination. Immunogenicity-fever index based on hemagglutination inhibition and microneutralization assays showed that 1.9 µg HA/AS03 B ranked the highest. Antibody levels persisted >4 times above baseline 12 months after primary vaccination with all formulations (day 385). Antibodies increased >4-fold after antigen challenge (day 392/day 385) with 1.9 µg HA/AS03 B, 0.9 µg HA/AS03 C and 1.9 µg HA/AS03 C formulations. Overall per subject, the incidence of fever ranged from 28.6% (3.75 µg HA/AS03 D) to 60.5% (1.9 µg HA/AS03 B). Conclusions: All formulations were highly immunogenic and demonstrated acceptable safety profiles, with the 1.9 µg HA/AS03 B providing the most favorable balance of immunogenicity versus reactogenicity for use in children 6–35 months of age.

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  • The United States has approved H5N1 vaccines based on additional H5 HAs such as the Q-Pan H5N1 vaccine by GlaxoSmithKline which contains both A/Vietnam and the A/Indonesia/5/2005 H5N1 clade 2.1.3.2 HA.

    “In addition, the United States has approved H5N1 vaccines based on additional H5 HAs such as the Q-Pan H5N1 vaccine by GlaxoSmithKline which contains both A/Vietnam and the A/Indonesia/5/2005 H5N1 clade 2.1.3.2 HA8,34”

    From Clade 2.3.4.4b but not historical clade 1 HA replicating RNA vaccine protects against bovine H5N1 challenge in mice (2025) · cites this paper as [34]

    Materials and Methods (Vaccines, Schedule and Blinding; page unavailable) identifies the GSK Q-Pan vaccine used in the study as containing A/Indonesia/5/2005 clade 2.1.3.2 HA. The introductory passage says GSK vaccines contain A/Indonesia or A/Vietnam HA, not that this Q-Pan formulation contains both. The cited copy does not establish U.S. approval. (LLM, conf=0.88)

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Metadata

Authors
Kim, J. H., Drame, M., Puthanakit, T., Chiu, N.-C., Supparatpinyo, K., Huang, L.-M., Chiu, C.-H., Chen, P.-Y., Hwang, K.-P., Danier, J., Friel, D., Salaun, B., Woo, W., Vaughn, D. W., Innis, B., & Schuind, A.
Affiliations
  • GlaxoSmithKline (United States) (US)
  • Vaccine Biostatistics Department, GSK, Rockville, Maryland
  • Chulalongkorn University (TH)
  • Department of Pediatrics, Mackay Children’s Hospital, Taipei, Taiwan
  • Chiang Mai University (TH)
  • National Taiwan University Hospital (TW)
  • Chang Gung University (TW)
  • Taichung Veterans General Hospital (TW)
  • China Medical University (TW)
  • GlaxoSmithKline (Belgium) (BE)
  • Program for Appropriate Technology in Health (US)
Corresponding author
  • Kim, Joon Hyung
  • Chiu, Cheng-Hsun
  • Woo, Wayne
ORCID
Venue
Pediatric Infectious Disease Journal
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2021-07-19
Volume
40
Issue
9
Pages
e333-e339
ISSN
0891-3668 (ISSN-L)
DOI
10.1097/inf.0000000000003247
PMC
PMC8357047
OpenAlex
W3184436507
Cited by
14
References
14
Citations by year
2026: 2 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 4
FWCI
1.62
Type
journal article
Language
en
Open access
Licence
Locations
  • The Pediatric Infectious Disease Journal (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords
AS03 adjuvant, childhood immunization, immunogenicity, vaccine safety, hemagglutination inhibition, microneutralization, antigen challenge, fever incidence, tocopherol content, dose-ranging, antibody persistence
MeSH terms
Immunogenicity, Vaccine, Adjuvants, Immunologic, Antibodies, Viral, Child, Preschool, Dose-Response Relationship, Immunologic, Female, Humans, Infant, Influenza, Human, Influenza Vaccines, Male, Influenza A Virus, H5N1 Subtype

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