The Phase I, double-blind, randomized study in 50 healthy adults aged 18–49 years (CTRI/2010/091/000082) compared see more the safety of two Al(OH)3 adjuvanted whole virion formulations (10 μg and 15 μg haemagglutinin (HA) per dose). Satisfactory

42-day follow-up data led to authorization for the Phase II/III double-blind, randomized study, carried out in 330 individuals (110 adults, 110 elderly and 110 adolescents and children ≥3 years) at five sites in India (CTRI/2010/091/000093). Following single dose of either 10 μg or 15 μg HA of the study vaccine given intramuscularly at 21 days apart, safety and immunogenicity were assessed and the vaccine found safe in all age groups. After 42 days of follow-up, no SAEs were reported and none of the few unsolicited events detected in each group was causally related to the study products. All solicited reactions reported in the groups were similar, mild in intensity and resolved without sequelae. Immunogenicity was assessed on Day click here 0 and 21 by

HAI assay. The vaccine-induced immune responses of both formulations were in line with published studies [6], [7] and [8]. Seroconversion and seroprotection (HI titres ≥1:40) rates met the requirements of the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for licensure in all three age groups. The DCG(I) granted the licence to market the 15 μg adjuvanted vaccine on 6 August 2010. As soon as six months of stability data are available, the 10 μg formulation will be registered and launched under the brand name Enzavac® in India. All the clinical studies were approved by the DCG(I), the Independent Review Board and the Institutional Ethics Committee. Additionally, all data were periodically reviewed and approved by an independent Data Safety Monitoring Board. Among other controls, an on-site regulatory audit for the manufacturing processes and quality control Calpain testing was carried out by an inspection team from WHO, the CDSCO/DCG(I), and local FDA in April 2010. During the entire clinical development and licensing of the IIV and

LAIV, SII was actively supported by the government agencies since the need for a pandemic vaccine in India was clear. As a result, they approved importation of the H1N1 vaccine strain, clinical trial protocols and finally licensure on a fast-track basis. In parallel, SII proactively apprised these agencies of developments at each stage of the project. For instance, while requirements for the production and use of IIV are long established, the WHO guidelines for the manufacture and evaluation of LAIV were being updated. Policy-makers and the scientific community were also apprehensive over issues such as potential reversion of attenuation to virulent phenotype, emergence of more pathogenic viruses from reassortant between vaccine strain and wild type strain, and limited safety data.