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Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study

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Abstract

Introduction and Aim

A trivalent live attenuated influenza vaccine (Nasovac-S®) was developed and licensed in India. A phase 4 study was conducted to assess safety.

Methodology

This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries.

Results

Among 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18–49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine.

Conclusions

The data from the study adds to the existing safety database of Nasovac-S.

Registry

Clinical Trials Registry of India (CTRI/2015/08/006074).

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Acknowledgements

The authors gratefully acknowledge the contributions of all the study participants for making this study a success. We also acknowledge the support of Dr. Rajeev Dhere, Dr. Leena Yeolekar, Dr. Bhagwat Gunale and Dr. Dhananjay Kapse of SIIPL for their work during the study. We also thank Dr. Larissa Rudenko of IEM, Russian Federation. Lastly, we thank Dr. Sanjeev Sarmukaddam for his contribution to the statistical calculations.

Author information

Authors and Affiliations

  1. Pravara Institute of Medical Sciences, Loni, India

    Prashant V. Nigwekar & Anuj Kumar

  2. Jehangir Hospital, Pune, India

    Vikram V. Padbidri

  3. KPC Medical College, Kolkata, India

    Amlan Choudhury

  4. Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India

    Amol B. Chaudhari & Prasad S. Kulkarni

Authors
  1. Prashant V. Nigwekar
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  2. Anuj Kumar
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  3. Vikram V. Padbidri
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  4. Amlan Choudhury
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  5. Amol B. Chaudhari
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  6. Prasad S. Kulkarni
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Corresponding author

Correspondence to Amol B. Chaudhari.

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Funding

The study was sponsored by the Serum Institute of India Pvt. Ltd., Pune, which manufactured the vaccine.

Conflict of Interest

Amol Chaudhari and Prasad Kulkarni are employed by the Serum Institute of India Pvt. Ltd., which manufactured the vaccine. Prashant Nigwekar, Anuj Kumar, Vikram Padbidri, and Amlan Choudhury have no conflict of interest that is directly relevant to the content of this study.

Ethical Approval

The study was initiated only after obtaining written approval from institutional ethics committees (IECs) of the respective sites as well as the Indian regulatory authority (Drugs controller General of India). The Declaration of Helsinki, Good Clinical Practice guidelines, and Indian regulatory and ethical guidelines were complied with.

Consent

Written informed consent from subjects (≥ 18 years of age) or parents (for subjects < 18 years of age) and written assent from children (7–17 years) were obtained prior to performing any study procedures. The consent forms and any subsequent amendments were reviewed and approved by respective sites’ IECs. The entire process of informed consent was audio-visually recorded only after additional consent for audio visual recording, as per the prevalent regulatory norms.

Additional information

Sponsor

Serum Institute of India Pvt. Ltd., Pune (which is also the manufacturer of the vaccine).

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Nigwekar, P.V., Kumar, A., Padbidri, V.V. et al. Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study. Drug Saf 41, 171–177 (2018). https://doi.org/10.1007/s40264-017-0605-3

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  • DOI: https://doi.org/10.1007/s40264-017-0605-3

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