Adults 18 to 49, any sex, with Norovirus Prevention. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First InjectionPrimary· Days 1 through 7
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First InjectionPrimary· Days 1 through 7
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.
Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First InjectionPrimary· Days 1 through 7
Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Percentage of Participants With Serious Adverse Events (SAEs) After the First InjectionPrimary· From first injection (Day 1) to second injection pre-dose (Up to Day 365)
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With Serious Adverse Events (SAEs) After the Second InjectionPrimary· From second injection (Day 365) to 6 months after second injection (Up to Day 545)
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With Adverse Events of Special Interest (AESI) After the First InjectionPrimary· From first injection (Day 1) to second injection pre-dose (Up to Day 365)
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second InjectionPrimary· From second injection (Day 365) to 6 months after second injection (Up to Day 545)
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the StudyPrimary· Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second InjectionSecondary· Days 365 through 371
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second InjectionSecondary· Days 365 through 371
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.
Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second InjectionSecondary· Days 365 through 371
Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Time frame: Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545).
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs, Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from the trial.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02038907 — Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
· Phase 2
· completed
Other Takeda trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 21 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02142504.