Prevention of gastroenteritis caused by norovirus MedDRA version: 20.1 Level: PT Classification code 10068189 Term: Gastroenteritis norovirus System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not available
Current Sponsor code: GI.1 NV-VLP
Other descrip
Sponsors
Takeda Vaccines, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male and female subjects aged between 6 weeks and less than 9 years at the time of enrollment. * Subjects 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 subject’s legally authorized 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. An assent will also be obtained according to age appropriate country-specific regulations. * Individuals who can comply with trial procedures and are available for the duration of the trial. Are the trial subjects under 18? yes Number of subjects for this age range: 840 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a clinically significant active infection (as assessed by the investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the intended date of vaccination. 2. Subjects who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration. 3. Known hypersensitivity or allergy to investigational vaccine 4. Subjects with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the trial. 5. Subjects with a history of any progressive or severe neurologic disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barré syndrome). 6. Known or suspected impairment/alteration of immune function, including the following: a. Children <18 months of age with history of repeated episodes of acute otitis media (AOM) in the first 6 months of life (AOM defined as a bulging tympanic membrane) and not to be confused with otitis media with effusion (OME). b. Chronic use of oral steroids (equivalent to 20 mg/day prednisone for =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed). c. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1. d. Receipt of immunostimulants within 60 days prior to Day 1. e. Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial. f. Receipt of immunosuppressive therapy within 6 months prior to Day 1. g. Human immunodeficiency virus (HIV) infection or HIV-related disease. h. Chronic Hepatitis B or C infection. i. Heritable immunodeficiency. 7. Abnormalities of splenic or thymic function. 8. Subjects with a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 9. Subjects with any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease). 10. Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial. 11. Subjects who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial. 12. Subjects who are first degree relatives of individuals involved in trial conduct. 13. Subjects with a history of autoimmune disease. 14. There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (eg, body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for trial enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To select the optimal formulation of the NoV bivalent VLP vaccine from different dosages of VLP for further development: * By assessing the seroresponse rate (percentage of subjects with =4-fold rises) in serum anti-NoV GI.1 VLP and GII.4 VLP antibody titers by Pan immunoglobin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). * By assessing the safety profile of different formulations of the NoV bivalent VLP vaccine as measured by solicited local and systemic adverse events (AEs) for the period of 7 days after each vaccination and as measured by the occurrence of unsolicited AEs 28 days after each vaccination, and serious adverse events (SAEs) throughout the trial.;Secondary Objective: * To evaluate the geometric mean titers (GMT) and GMFRs of anti-NoV GI.1 VLP and GII.4 VLP antibody titers as measured by Pan-Ig ELISA. * To evaluate the seroresponse rate in serum anti-NoV GI.1 VLP and/or GII.4 VLP antibody blocking titers as measured by histoblood group antigen (HBGA) binding assay. * To evaluate Geometric Mean Blocking Titers (BT50) and GMFR of serum anti-NoV antibody titers for GI.1 VLP and GII.4 VLP as measured by the HBGA binding assay. * To assess safety by the incidence of AEs leading to subject’s withdrawal from the trial throughout the trial.;Primary end point(s): Immunogenicity • Seroresponse rate (defined as percentage of subjects with a 4-fold rise or greater) in serum anti-NoV antibody titers for both GI.1 VLP and GII.4 VLP as measured by Pan-Ig ELISA at Day 57 (Cohort 1) and Day 140 (Cohort 2). Safety • Percentage of subjects with solicited local AEs of injection site pain, erythema, induration, and swelling on the day of vaccination and then daily through Day 7 after each vaccination (including the day of vaccination). • Percentage of subjects with solicited systemic AEs of headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to <9 years; and irri | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity Pan-Ig ELISA • Seroresponse rate in serum anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). • Seroresponse rate in serum anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMT of anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMT of anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMFR of anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMFR of anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2). HBGA Binding Assay • Seroresponse rate in serum anti-NoV GI.1 VLP and GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • Seroresponse rate in serum anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • Seroresponse rate in serum anti-NoV GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • BT50 of anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • BT50 of anti-NoV GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMFR of anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). • GMFR of anti-NoV GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2). Safety • Percentage of subjects with any AE leading to subject’s withdrawal from the trial - from the day of vaccination through Day 210 (Cohort 1) and Day 293 (Cohort 2).;Timepoint(s) of evaluation of this end point: Timepoint of evalution occuring a | — |
Countries
Colombia, Finland, Panama
Contacts
Public ContactTaisei Masuda
Takeda Vaccines Inc
Outcome results
None listed