Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants-Reference-Cited by-同舟云学术

Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants

Published:2023-11-15 Issue:3 Volume:19 Page:
ISSN:2164-5515
Container-title:Human Vaccines & Immunotherapeutics
language:en
Short-container-title:Human Vaccines & Immunotherapeutics

Author:

P Krishna Kumari¹,Chiteti Siddharth Reddy¹,Aileni Vinay K.¹,Babji Sudhir²,Blackwelder William C.³,Kumar Ashok⁴,Vagha Jayant⁵,Nayak Uma⁶,Mitra Monjori⁷,D Narayanaappa⁸,Kar Sonali⁹,Yadav Sangeeta¹⁰,Naidu Swamy¹¹,Mahantshetti Niranjan¹²,Khalatkar Vasant¹³,Mohapatra Satyajit¹⁴,Purthi P. K.¹⁵,Sharma Pawan¹⁶,Kannan A.¹⁷,Dhongade Ramchandra Keshav¹⁸,Prasad Sai D.¹,Ella Raches¹,Vadrevu Krishna Mohan¹

Affiliation:

1. Medical Affairs Department, Bharat Biotech International Limited, Hyderabad, India

2. Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India

3. Statistics, Independent Clinical Development Consultant, Bethesda, MD, USA

4. Department of Paediatrics, Banaras Hindu University, Varanasi, India

5. Department of Paediatrics, Datta Megha Institute of Medical Sciences, Wardha, India

6. Department of Paediatrics, GMERS Medical College, Vadodara, India

7. Department of Paediatrics, Institute of Child Health, Kolkata, India

8. Department of Paediatrics, Jagadguru Shivarathreeshwara Medical College, Mysore, India

9. Department of Community Medicine, Kalinga Institute of Medical Sciences, Bhubaneswar, India

10. Department of Paediatrics, Maulana Azad Medical College, New Delhi, India

11. Department of Paediatrics, King George Hospital, Vishakapatnam, India

12. Department of Paediatrics, Dr. Prabhakar Kore Medical College & Hospital, Belgaum, India

13. Department of Paediatrics, Khalatkar Hospital, Nagpur, India

14. Department of Pharmacology, SRM Medical College, Chennai, India

15. Department of Paediatrics, Sri Ganga Ram Hospital, New Delhi, India

16. Department of Paediatrics, Maharshi Hospital & Research Centre, Jaipur, India

17. Department of Paediatrics, Meenakshi Mission Hospital, Chennai, India

18. Department of Paediatrics, Sant Dnyaneshwar Medical Education Research Center, Pune, India

Funder

Bharat Biotech International Limited

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/21645515.2023.2278346

Reference35 articles.

1. Meeting of the Strategic Advisory Group of Experts on Immunization April 2009: conclusions and recommendations. [accessed 2023 May 17]. https://www.who.int/publications-detail-redirect/WER8423.

2. Protection Conferred by Neonatal Rotavirus Infection against Subsequent Rotavirus Diarrhea

3. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial

4. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life

5. Introducing rotavirus vaccine in the Universal Immunization Programme in India: From evidence to policy to implementation

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