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Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039790
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE February 21, 2017
Estimated Primary Completion Date October 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]
    GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay.
  • GMBT50 of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]
    GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Geometric Mean Blocking Titers (GMBT50) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years ]
    GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay.
  • Geometric Mean Blocking Titers (GMBT50) of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years ]
    GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]
    GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA).
  • GMT of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]
    GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years ]
    GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA).
  • Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years ]
    GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
Official Title  ICMJE A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
Brief Summary The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.
Detailed Description

The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.

The study will enroll maximum of 575 participants. Participants who previously received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants from study NOR-107 will enter the study at the time of their 3rd year post-primary vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary vaccination. The duration of participation in the study will be different for each participant.

This multi-center trial will be conducted in Belgium and the United States. The overall time to participate in this study is maximum 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Volunteers
  • Norovirus
Intervention  ICMJE Biological: NoV Vaccine
No NoV vaccine injection administered.
Study Arms  ICMJE Experimental: NoV Vaccine
Participants who previously received NoV vaccine adjuvanted with aluminum as aluminum hydroxide or with monophosphoryl lipid A (MPL), injection, intramuscularly as planned in studies NOR-107, NOR-210 and NOR-204 will be assessed over 5 years post-primary vaccination. Vaccine formulations according to the parent trials: NOR-107, 210 and 204.
Intervention: Biological: NoV Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
528
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
800
Estimated Study Completion Date  ICMJE October 26, 2021
Estimated Primary Completion Date October 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107, NOR-210 and NOR-204, have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

Exclusion Criteria:

  1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
  2. In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
  3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03039790
Other Study ID Numbers  ICMJE NOR-213
2016-004288-37 ( EudraCT Number )
U1111-1189-7907 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP