Safety and immunogenicity of locally produced trivalent inactivated influenza vaccine (Tri Fluvac) in healthy Thai adults aged 18–64 years in Nakhon Phanom: A Phase III double blinded, three-arm, randomized, controlled trial

Author:

Prasert Kriengkrai,Praphasiri PrabdaORCID,Lerdsamran Hatairat,Nakphook Sutthichai,Ditsungnoen Darunee,Chawalchitiporn Sutthinan,Sornwong Kanlaya,Poopipatpol Kittisak,Wirachwong Ponthip,Narakorn Piengthong,Surichan Somchaiya,Suthepakul Nava,Thangsupanimitchai Napawan,Pittayawonganon Chakrarat,Puthavathana Pilaipan,Davis William W.,Mott Joshua A.,Olsen Sonja J.,Patumanond Jayanton

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference29 articles.

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2. Development of influenza vaccine production capacity by the Government Pharmaceutical Organization of Thailand: addressing the threat of an influenza pandemic;Surichan;Vaccine,2011

3. FDA. Non-Inferiority Clinical Trials to Establish Effectiveness: Guidance for Industry. Available at: https://www.fda.gov/media/78504/download [accessed April 14].

4. FDA. Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines. Available at: https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Guidance-for-Industry--Clinical-Data-Needed-to-Support-the-Licensure-of-Seasonal-Inactivated-Influenza-Vaccines.pdf [accessed April 13].

5. WHO. WHO surveillance case definitions for ILI and SARI. Available at: https://www.who.int/teams/global-influenza-programme/surveillance-and-monitoring/case-definitions-for-ili-and-sari#:∼:text=SARI%20case%20definition,within%20the%20last%2010%20days.

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