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Clinical / Regulatory

Section Editor(s): Ronald Ellis, Biotech and Biopharma, Jerusalem, IL

Clinical trial design and related issues, regulatory issues for preclinical studies, clinical trials, and post-marketing trials.

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Human Vaccines & Immunotherapeutics
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Human Vaccines & Immunotherapeutics sections

Acceptance & Hesitation
Clinical / Regulatory
Communication
Coronavirus
Field Use
Hepatitis
HPV
Immunology
Immunotherapy - Cancer
Immunotherapy - Other
Influenza
Licensed Vaccines
Meningococcal
Novel Vaccines
Passive Immunization
Pneumococcal
Public Health and Policy
Rotavirus
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“Direct and indirect impacts of the COVID-19 pandemic on operational conduct of pediatric vaccine clinical trials”Open Access
Monica Anne McArthur, Siham Bchir, Estelle Dubois, Lucia Gan, Eric Gerchman, Sandeep Gupta, Olga Liabis, Lucia Perez, Fabienne Roche, Gustavo Vasquez, Betzana Zambrano, Sanjay Gurunathan & Mandeep Singh Dhingra
Human Vaccines & Immunotherapeutics, Volume 19, 2023 - Issue 3
Article | Published online: 09 Nov 2023 | Views: 742
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Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of NepalOpen Access
Ram Hari Chapagain, Jessica Maharjan, Santosh Adhikari, Prabhat Thapa, Kshitij Kunwar, Bishnu Rath Giri, Nisha Jyoti Shrestha, Anil Kumar Shrestha, Sanjeet Kumar Shrestha, Suresh Man Tamang, Haeun Cho, Eun Lyeong Park, Jiyoung Lee, Jinae Lee, Deok Ryun Kim, Jae Seung Yang, Tarun Saluja, Anh Wartel, Julia Lynch & Katerina Rok Song
Human Vaccines & Immunotherapeutics, Volume 19, 2023 - Issue 2
Brief Report | Published online: 04 Aug 2023 | Views: 763
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The collective voice of early phase COVID-19 vaccine trial participants: Insights for improving confidence in novel vaccinesOpen Access
Tonia M. Thomas, Susanne H. Hodgson, Katherine Emary, Maia Patrick-Smith, Rebecca te Water Naude, Arabella S. V. Stuart, John Henry, Marcus English, Maria Moore, Naomi Douglas, Andrew J. Pollard & Samantha Vanderslott
Human Vaccines & Immunotherapeutics, Volume 19, 2023 - Issue 1
Brief Report | Published online: 03 May 2023 | Views: 1507
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Foundations for improved vaccine correlate of risk analysis using positive-unlabeled learningOpen Access
Natasha S. Kelkar, Kyle S. Morrison & Margaret E. Ackerman
Human Vaccines & Immunotherapeutics, Volume 19, 2023 - Issue 1
Article | Published online: 03 May 2023 | Views: 1226 | Citations: 2
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