Safety and immunogenicity of adjuvanted inactivated split-virion and whole-virion influenza A (H5N1) vaccines in children: a phase I-II randomized trial

Vaccine
Jiang WuZi-Jian Feng

Abstract

Highly pathogenic avian influenza A virus H5N1 has the potential to cause a pandemic. Many prototype pandemic influenza A (H5N1) vaccines had been developed and well evaluated in adults in recent years. However, data in children are limited. Herein we evaluate the safety and immunogenicity of adjuvanted split-virion and whole-virion H5N1 vaccines in children. An open-labelled phase I trial was conducted in children aged 3-11 years to receive aluminum-adjuvated, split-virion H5N1 vaccine (5-30 microg) and in children aged 12-17 years to receive aluminum-adjuvated, whole-virion H5N1 vaccine (5-15 microg). Safety of the two formulations was assessed. Then a randomized phase II trial was conducted, in which 141 children aged 3-11 years received the split-virion vaccine (10 or 15 microg) and 280 children aged 12-17 years received the split-virion vaccine (10-30 microg) or the whole-virion vaccine (5 microg). Serum samples were collected for hemagglutination-inhibition (HI) assays. 5-15 microg adjuvated split-virion vaccines were well tolerated in children aged 3-11 years and 5-30 microg adjuvated split-virion vaccines and 5 microg adjuvated whole-virion vaccine were well tolerated in children aged 12-17 years. Most local and systemi...Continue Reading

References

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Citations

Mar 5, 2014·Molecular Therapy : the Journal of the American Society of Gene Therapy·Min-Chul KimSang-Moo Kang
Jun 4, 2015·Emerging Microbes & Infections·Zhenglun LiangJunzhi Wang
Jul 16, 2014·Expert Review of Vaccines·Brendon Y ChuaDavid C Jackson
Jun 23, 2015·Expert Review of Vaccines·Barnaby E YoungYee Sin Leo
Feb 9, 2012·Expert Review of Vaccines·Roberto GaspariniDonatella Panatto
Jun 4, 2013·Virus Research·Mariana BazKanta Subbarao
Aug 17, 2011·Biotechnology Advances·Assunta PelosiAmanda M Walmsley
Sep 18, 2013·The Journal of Infectious Diseases·Maikel V W van der VeldenGerald Aichinger
Dec 28, 2016·International Journal of Molecular Sciences·Aitor Nogales, Luis Martínez-Sobrido

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