Chauhan, Anahita R.
Nandanwar, Yogeshwar S.
Ramaiah, Aruna
Yelikar, Kanan A.
Rashmi, M. D.
Sachan, Rekha
Mayekar, Rahul V.
Trivedi, Yamini N.
Paradkar, Gopalkrishna V.
Patole, Kiran P.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Funding for this research was provided by:
Bharat Serums and Vaccines Ltd.
Article History
Received: 12 December 2018
Accepted: 29 April 2019
First Online: 3 June 2019
Compliance with Ethical Standards
:
: The trial protocol was approved by the Indian drug regulatory authority CDSCO (Central Drugs Standard Control Organization). The trial protocol was approved by the institutional ethics committees of all nine participating centres individually. The trial was registered with the CTRI (Clinical Trials Registry - India) prior to commencement. The trial was performed in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, and local regulatory requirements.
: The authors declare that they have no conflict of interest, nor do they have any commercial association or financial interest in the publication of this manuscript. The authors take complete responsibility for the integrity of the data and the accuracy of the data analysis.
: Informed consent was obtained from all individual participants included in the study by the respective investigators at each study site.
: The clinical study was unconditionally supported financially and materially by Bharat Serums and Vaccines Limited.
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