JPRN-jRCT2051230076
Recruiting
Phase 1
A Phase 1, Randomized, Double-blind, Multi-center, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Healthy Japanese Infants 5 Months of Age at First Trial Vaccine Administration
Takahashi Kazuma0 sites21 target enrollmentJuly 25, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of norovirus-associated acute gastroenteritis.
- Sponsor
- Takahashi Kazuma
- Enrollment
- 21
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subject aged 5 months (\-14/\+14 days).
- •Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
- •The subjects legally acceptable representative (LAR) signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- •The subjects LAR is willing and able to comply with trial procedures and is available for the duration of follow\-up.
Exclusion Criteria
- •Clinically significant abnormality in growth by length/height, weight, or head circumference (according to national guidelines).
- •Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
- •Chronic use of oral corticosteroids (equivalent to 20 mg/day prednisolone for \>\=12 weeks / \>\=2 mg/kg body weight /day for \>\=2 weeks) within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
- •Use of parenteral corticosteroids (equivalent to 20 mg/day prednisolone for \>\=12 weeks / \>\=2 mg/kg body weight /day for \>\=2 weeks. Use of inhaled, intranasal or topical corticosteroid is allowed) within 60 days prior to Visit 1\.
- •Receipt of immunostimulants within 60 days prior to Visit 1\.
- •Receipt of parenteral, epidural or intra\-articular immunoglobulin (Ig) preparations, blood products, and/or plasma derivatives within 90 days prior to Visit 1 or planned during the full duration of the trial.
- •Receipt of immunosuppressive therapy prior to Visit 1\.
- •Known hypersensitivity or allergy to any of the trial vaccine components (including excipients).
- •Any clinically significant active infection (as assessed by the investigator) or temperature \>\= 38\.0 C (\>100\.4 F), regardless of method used, within 3 days prior to intended trial vaccine administration.
- •Gastroenteritis within 7 days before planned dosing (can warrant delay of trial vaccine administration).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Intranasal Adenoviral vector COVID-19 vaccine (BBV154) Phase 1 studyCTRI/2021/02/031295Bharat Biotech International Ltd
Terminated
Phase 1
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Topical SM04755 Solution Following Topical Administration to Subjects with Mild to Moderate Plaque PsoriasisACTRN12617001178336Samumed Pacific Pty Ltd13
Not yet recruiting
Phase 1
A Study to Evaluate BW-00163 in Subjects with HypertensioACTRN12622001430729ARGO BIOPHARMA AUSTRALIA PTY LTD48
Completed
Not Applicable
A Phase 1 Clinical study, Safety, Tolerability and PK of SP-8203Diseases of the nervous systemKCT0001742Shin Poong Pharm72
Active, not recruiting
Not Applicable
A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg plus Copegus 800 mg in Interferon-naïve Patients with Chronic Hepatitis C Genotype 1 virus infection coinfected with human immunodeficiency virus (HIV-1).Patients with chronic hepatitis C (CHC) genotype 1 virus coinfected with human immunodeficiency virus type 1 (HIV-1)EUCTR2005-005506-23-PTF. Hoffmann-La Roche Ltd400