A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac^®) in India

Abstract

A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (≥ 3 y) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 d. Among 7,565 individuals (3–85 y), a total of 81 solicited adverse reactions (1%) were reported in 49 subjects (0.65%). The reactions included mild to moderate respiratory symptoms. No H1N1 case was encountered during one year post vaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.

Keywords: :

• live attenuated
• pandemic H1N1 vaccine
• post-marketing surveillance

Acknowledgments

We thank the study participants and the field workers who collected the data.

Disclosure of Potential Conflicts of Interest

P.S.K. and R.MD are employed by Serum Institute of India Ltd which is the manufacturer of the study vaccine. S.K.R. is a past employee of the same organization.

Funding

The study was funded by Serum Institute of India Ltd which is the manufacturer of the study vaccine.