Prevention of gastroenteritis caused by norovirus MedDRA version: 16.1 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: Injection
INN or Proposed INN: Not available
Current Sponsor code: GI.1 NV-VLP
Other descriptive name: GI.1
Sponsors
Takeda Vaccines (Montana), Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects between 17 and 64 years of age 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 or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form (and assent form in the case of adolescents) 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. - Subjects 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: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects who have received any vaccination that included Hepatitis A vaccine within the last 5 years. - Subjects with known hypersensitivity to any of the vaccine components. - Subjects with contraindications, warnings, and/or precautions to vaccinations with Havrix. - Subjects with known or suspected impairment/alteration of immune function. - Female subjects who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To select the optimal formulation of the investigational vaccine from different concentrations of VLP and MPL adjuvant for further development: - By assessing the seroresponse rate (=4-fold rise) of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers by Pan-Ig enzyme-linked immunosorbent assay (ELISA) at Day 56. - By assessing the safety profile of different formulations of the investigational vaccine as measured by solicited local and systemic adverse events (AEs) for the period of 7 days after each vaccination (including the day of 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: GMT & GMFR of anti-norovirus GI.1 VLP and GII.4 VLP AB titers Percentage of subjects with 4-fold rise or > of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB titers. GMT and GMFR of anti-norovirus GI.1 VLP and GII.4 VLP AB titers Percentage of subjects with a 4-fold rise or > of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB titers BT50 & GMFR of serum anti-norovirus AB titers for GI.1 VLP and GII.4 VLP as measured by the HBGA binding assay at Day 28, 56, 208 & 393. Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB blocking titers BT50 and GMFR of serum anti-norovirus AB titers of a panel of GI.1 and GII.4 not represented in the vaccine To assess safety by the occurrence of Significant New Medical Conditions and unsolicited 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-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by Pan-Ig ELISA at Day 56. Safety - Percentage of subjects with solicited local AEs at injection site: pain, erythema, induration, and swelling for 7 days after each vacc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for this trial are as follows (note that immunogenicity analyses at Day 28 apply only to the 2 dose groups): Immunogenicity Pan-Ig ELISA - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 208, and Day 393. - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. - GMT of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. - GMT of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. - GMFR of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. - GMFR of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393. IgA ELISA - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393. - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393. - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393. - GMT of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393. - GMT of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393. GMFR of anti-norovirus GI.1 VLP | — |
Countries
Belgium
Contacts
Public ContactFrank Baehner
Takeda Pharmaceuticals International GmbH
Outcome results
None listed