A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants
| Autor: | Rajeev Zachariah Kompithra, Dan Bi, Amita Sapru, Adrian Caplanusi, Shruti Saha, Leentje Moerman, Brigitte Cheuvart, Sanjay Gandhi, Mallesh Kariyappa, Sanjay Lalwani, Catherine Cohet, Monjori Mitra, P.V. Varughese |
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| Rok vydání: | 2021 |
| Předmět: |
Rotavirus
Immunoglobulin A medicine.medical_specialty Immunology Antibodies Viral Vaccines Attenuated Gastroenterology Rotavirus Infections Immunogenicity Vaccine Internal medicine Human rotavirus otorhinolaryngologic diseases medicine Humans Immunology and Allergy Seroconversion Adverse effect Pharmacology Reactogenicity biology business.industry Rotavirus Vaccines Infant virus diseases Rotavirus vaccine Confidence interval Clinical trial biology.protein business circulatory and respiratory physiology |
| Zdroj: | Human Vaccines & Immunotherapeutics. 17:4646-4653 |
| ISSN: | 2164-554X 2164-5515 |
| DOI: | 10.1080/21645515.2021.1960136 |
| Popis: | The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6-10 weeks received 2 doses (1 month apart) of either Liq HRV or Lyo HRV. Non-inferiority of Liq HRV compared to Lyo HRV was assessed in terms of geometric mean concentrations (GMCs) of anti-RV immunoglobulin A (IgA), 1-month post-second dose (primary objective). Reactogenicity/safety were also evaluated. Seroconversion was defined as anti-RV IgA antibody concentration ≥20 units [U]/mL in initially seronegative infants (anti-RV IgA antibody concentration |
| Databáze: | OpenAIRE |
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