Immunogenicity and safety of Havisure TM vaccine developed by Human Biologicals Institute in healthy subjects of 12 months to 49 years of age: A phase II/III, randomized, single blind, non-inferiority study - Susarla, Sai Krishna; Gupta, Madhu; Uttam, Kheya Ghosh; Palkar, Sonali; Dhongade, Ashish Ramachandra; Siva Ram Prasad, K; Rajapantula, Vasudev; Ravi, M.D; Pradeep, N; Satish, M; Rajashakar, B.C; Sandhya, G; et al. (Vaccine, 2023)
Keywords: Adverse events; Age; Age groups; Allergy and Immunology; Aluminum; Antibodies; Antigens; Clinical trials; Disease transmission; Estimation; Food contamination; Headache; Hepatitis; Hepatitis A; Hygiene; Immunogenicity; Infections; Ingestion; Liver diseases; Oral administration; Personal hygiene; Randomization; Safety; Sample size; Seroconversion; Vaccines; India; PP; CTCAE; Not less than; Hepatitis A virus; ITT; Standard Deviation; Legally Acceptable Representative; Adverse Event; HBI; Medical Dictionary for Regulatory Activities; SD; Havrix® vaccine; Non-inferiority; NLT; Safety; Per Protocol; Common Terminology Criteria for Adverse Events; Havisure™ vaccine; Geometric Mean Titre; AE; MedDRA; CI; DAIDS; GMT; Intention to Treat; Serious Adverse Event; Immunogenicity; Confidence Interval; Division of AIDS; NMT; SAE; q.s; quantum sufficient; HAV; LAR; Human Biologicals Institute; Not more than