NCT02661490 is a Phase 2 clinical trial of Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Norovirus, sponsored by Takeda.

Who is sponsoring NCT02661490?

NCT02661490 is sponsored by Takeda.

What drugs are being tested in NCT02661490?

Interventions in NCT02661490: Norovirus GI.1/GII.4 Bivalent VLP Vaccine, 0.9% sodium chloride (saline), Norovirus GI.1/GII.4 Bivalent VLP Vaccine.

Is NCT02661490 still recruiting?

NCT02661490 is currently completed. Last updated 18 May 2020.

Are results published for NCT02661490?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-05-18 · How we verify

NCT02661490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population

Completed Phase 2 Results posted Last updated 18 May 2020

What this trial tests

Phase 2 trial testing Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Norovirus in 320 participants. Completed in 29 September 2017.

Timeline

1 February 2016

Primary endpoint
28 October 2016

29 September 2017

Quick facts

Lead sponsor	Takeda
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	320
Start date	1 February 2016
Primary completion	28 October 2016
Estimated completion	29 September 2017
Sites	10 locations across United States

Drugs / interventions tested

Norovirus GI.1/GII.4 Bivalent VLP Vaccine — full drug profile →
0.9% sodium chloride (saline)
Norovirus GI.1/GII.4 Bivalent VLP Vaccine — full drug profile →

Conditions studied

Norovirus — all drugs for Norovirus →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Norovirus. 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 a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 Primary · Day 57

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	42.3	30.6 – 54.6
Arm 2: NoV Vaccine Formulation A_2-Dose	41.5	29.4 – 54.4
Arm 3: NoV Vaccine Formulation B_1-Dose	56.5	43.3 – 69.0
Arm 4: NoV Vaccine Formulation B_2-Dose	63.6	50.9 – 75.1
Arm 5: NoV Vaccine Formulation A_1-Dose	45.8	25.6 – 67.2

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 Primary · Within 7 days of first vaccination on Day 1

Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.

Any Solicited Local AEs

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	6.6
Arm 2: NoV Vaccine Formulation A_2-Dose	26.0
Arm 3: NoV Vaccine Formulation B_1-Dose	15.3
Arm 4: NoV Vaccine Formulation B_2-Dose	34.7
Arm 5: NoV Vaccine Formulation A_1-Dose	4.0

Pain

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	5.3
Arm 2: NoV Vaccine Formulation A_2-Dose	23.3
Arm 3: NoV Vaccine Formulation B_1-Dose	9.7
Arm 4: NoV Vaccine Formulation B_2-Dose	34.7
Arm 5: NoV Vaccine Formulation A_1-Dose	4.0

Erythema

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	1.3
Arm 2: NoV Vaccine Formulation A_2-Dose	2.7
Arm 3: NoV Vaccine Formulation B_1-Dose	4.2
Arm 4: NoV Vaccine Formulation B_2-Dose	1.4
Arm 5: NoV Vaccine Formulation A_1-Dose	4.0

Swelling

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	2.7
Arm 3: NoV Vaccine Formulation B_1-Dose	2.8
Arm 4: NoV Vaccine Formulation B_2-Dose	1.4
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Induration

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	1.4
Arm 3: NoV Vaccine Formulation B_1-Dose	1.4
Arm 4: NoV Vaccine Formulation B_2-Dose	1.4
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 Primary · Within 7 days of second vaccination on Day 29

Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.

Any Solicited Local AEs

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	37.0
Arm 2: NoV Vaccine Formulation A_2-Dose	21.7
Arm 3: NoV Vaccine Formulation B_1-Dose	38.2
Arm 4: NoV Vaccine Formulation B_2-Dose	39.4
Arm 5: NoV Vaccine Formulation A_1-Dose	41.7

Pain

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	32.9
Arm 2: NoV Vaccine Formulation A_2-Dose	21.7
Arm 3: NoV Vaccine Formulation B_1-Dose	38.2
Arm 4: NoV Vaccine Formulation B_2-Dose	37.9
Arm 5: NoV Vaccine Formulation A_1-Dose	41.7

Erythema

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	2.7
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	1.5
Arm 4: NoV Vaccine Formulation B_2-Dose	3.0
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Swelling

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	1.4
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	1.5
Arm 4: NoV Vaccine Formulation B_2-Dose	1.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Induration

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	1.4
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	1.5
Arm 4: NoV Vaccine Formulation B_2-Dose	1.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 Primary · Within 7 days of first vaccination on Day 1

Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.

Any solicited systemic AEs

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	28.9
Arm 2: NoV Vaccine Formulation A_2-Dose	34.2
Arm 3: NoV Vaccine Formulation B_1-Dose	30.6
Arm 4: NoV Vaccine Formulation B_2-Dose	44.4
Arm 5: NoV Vaccine Formulation A_1-Dose	36.0

Headache

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	7.9
Arm 2: NoV Vaccine Formulation A_2-Dose	2.7
Arm 3: NoV Vaccine Formulation B_1-Dose	11.1
Arm 4: NoV Vaccine Formulation B_2-Dose	12.5
Arm 5: NoV Vaccine Formulation A_1-Dose	20.0

Fatigue

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	18.4
Arm 2: NoV Vaccine Formulation A_2-Dose	24.7
Arm 3: NoV Vaccine Formulation B_1-Dose	9.7
Arm 4: NoV Vaccine Formulation B_2-Dose	27.8
Arm 5: NoV Vaccine Formulation A_1-Dose	28.0

Myalgia

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	5.3
Arm 2: NoV Vaccine Formulation A_2-Dose	13.7
Arm 3: NoV Vaccine Formulation B_1-Dose	11.1
Arm 4: NoV Vaccine Formulation B_2-Dose	20.8
Arm 5: NoV Vaccine Formulation A_1-Dose	16.0

Arthralgia

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	5.3
Arm 2: NoV Vaccine Formulation A_2-Dose	8.2
Arm 3: NoV Vaccine Formulation B_1-Dose	6.9
Arm 4: NoV Vaccine Formulation B_2-Dose	6.9
Arm 5: NoV Vaccine Formulation A_1-Dose	4.0

Vomiting

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	1.4
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0
Arm 4: NoV Vaccine Formulation B_2-Dose	2.8
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Diarrhea

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	5.3
Arm 2: NoV Vaccine Formulation A_2-Dose	6.8
Arm 3: NoV Vaccine Formulation B_1-Dose	8.3
Arm 4: NoV Vaccine Formulation B_2-Dose	18.1
Arm 5: NoV Vaccine Formulation A_1-Dose	8.0

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 Primary · Within 7 days of second vaccination on Day 29

Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.

Any solicited systemic AEs

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	19.2
Arm 2: NoV Vaccine Formulation A_2-Dose	20.3
Arm 3: NoV Vaccine Formulation B_1-Dose	20.6
Arm 4: NoV Vaccine Formulation B_2-Dose	28.8
Arm 5: NoV Vaccine Formulation A_1-Dose	16.7

Headache

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	8.2
Arm 2: NoV Vaccine Formulation A_2-Dose	5.8
Arm 3: NoV Vaccine Formulation B_1-Dose	5.9
Arm 4: NoV Vaccine Formulation B_2-Dose	6.1
Arm 5: NoV Vaccine Formulation A_1-Dose	4.2

Fatigue

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	12.3
Arm 2: NoV Vaccine Formulation A_2-Dose	15.9
Arm 3: NoV Vaccine Formulation B_1-Dose	13.2
Arm 4: NoV Vaccine Formulation B_2-Dose	15.2
Arm 5: NoV Vaccine Formulation A_1-Dose	8.3

Myalgia

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	6.8
Arm 2: NoV Vaccine Formulation A_2-Dose	5.8
Arm 3: NoV Vaccine Formulation B_1-Dose	7.4
Arm 4: NoV Vaccine Formulation B_2-Dose	13.6
Arm 5: NoV Vaccine Formulation A_1-Dose	4.2

Arthralgia

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	4.1
Arm 2: NoV Vaccine Formulation A_2-Dose	7.2
Arm 3: NoV Vaccine Formulation B_1-Dose	4.4
Arm 4: NoV Vaccine Formulation B_2-Dose	6.1
Arm 5: NoV Vaccine Formulation A_1-Dose	4.2

Vomiting

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0
Arm 4: NoV Vaccine Formulation B_2-Dose	1.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Diarrhea

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	1.4
Arm 2: NoV Vaccine Formulation A_2-Dose	4.3
Arm 3: NoV Vaccine Formulation B_1-Dose	2.9
Arm 4: NoV Vaccine Formulation B_2-Dose	4.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 Primary · Within 7 days of first vaccination on Day 1

The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0
Arm 4: NoV Vaccine Formulation B_2-Dose	0.0
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 Primary · Within 7 days of second vaccination on Day 29

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0
Arm 2: NoV Vaccine Formulation A_2-Dose	0.0
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0
Arm 4: NoV Vaccine Formulation B_2-Dose	1.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 Primary · Within 28 days of first vaccination on Day 1

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	32.9
Arm 2: NoV Vaccine Formulation A_2-Dose	28.4
Arm 3: NoV Vaccine Formulation B_1-Dose	33.3
Arm 4: NoV Vaccine Formulation B_2-Dose	26.4
Arm 5: NoV Vaccine Formulation A_1-Dose	20.0

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 Primary · Within 28 days of second vaccination on Day 29

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	34.2
Arm 2: NoV Vaccine Formulation A_2-Dose	18.8
Arm 3: NoV Vaccine Formulation B_1-Dose	25.0
Arm 4: NoV Vaccine Formulation B_2-Dose	30.3
Arm 5: NoV Vaccine Formulation A_1-Dose	8.3

Percentage of Participants With At Least One Serious Adverse Event (SAE) Primary · From first vaccination up to Day 393

An SAE is any untoward medical occurrence 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.

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	9.2
Arm 2: NoV Vaccine Formulation A_2-Dose	12.2
Arm 3: NoV Vaccine Formulation B_1-Dose	23.6
Arm 4: NoV Vaccine Formulation B_2-Dose	12.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0

Percentage of Participants 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 HBGA Blocking Assay Secondary · Days 8, 29, 36, 211 and 393

Day 8

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 5.0
Arm 2: NoV Vaccine Formulation A_2-Dose	33.8	22.6 – 46.6
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0	0.0 – 5.4
Arm 4: NoV Vaccine Formulation B_2-Dose	55.4	42.5 – 67.7
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 14.8

Day 29

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 5.0
Arm 2: NoV Vaccine Formulation A_2-Dose	40.9	29.0 – 53.7
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0	0.0 – 5.4
Arm 4: NoV Vaccine Formulation B_2-Dose	54.5	41.8 – 66.9
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 14.2

Day 36

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	26.4	16.7 – 38.1
Arm 2: NoV Vaccine Formulation A_2-Dose	45.5	33.1 – 58.2
Arm 3: NoV Vaccine Formulation B_1-Dose	34.4	22.9 – 47.3
Arm 4: NoV Vaccine Formulation B_2-Dose	63.6	50.9 – 75.1
Arm 5: NoV Vaccine Formulation A_1-Dose	43.5	23.2 – 65.5

Day 211

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	15.5	8.0 – 26.0
Arm 2: NoV Vaccine Formulation A_2-Dose	18.2	9.8 – 29.6
Arm 3: NoV Vaccine Formulation B_1-Dose	28.1	17.6 – 40.8
Arm 4: NoV Vaccine Formulation B_2-Dose	30.3	19.6 – 42.9
Arm 5: NoV Vaccine Formulation A_1-Dose	8.7	1.1 – 28.0

Day 393

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	12.9	6.1 – 23.0
Arm 2: NoV Vaccine Formulation A_2-Dose	10.9	4.5 – 21.2
Arm 3: NoV Vaccine Formulation B_1-Dose	19.0	10.2 – 30.9
Arm 4: NoV Vaccine Formulation B_2-Dose	16.9	8.8 – 28.3
Arm 5: NoV Vaccine Formulation A_1-Dose	13.0	2.8 – 33.6

Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) Secondary · Days 8, 29, 36, 57, 211 and 393

Day 8

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	1.4	0.0 – 7.5
Arm 2: NoV Vaccine Formulation A_2-Dose	63.1	50.2 – 74.7
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0	0.0 – 5.4
Arm 4: NoV Vaccine Formulation B_2-Dose	76.9	64.8 – 86.5
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 14.8

Day 29

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 5.0
Arm 2: NoV Vaccine Formulation A_2-Dose	72.7	60.4 – 83.0
Arm 3: NoV Vaccine Formulation B_1-Dose	0.0	0.0 – 5.4
Arm 4: NoV Vaccine Formulation B_2-Dose	77.3	65.3 – 86.7
Arm 5: NoV Vaccine Formulation A_1-Dose	0.0	0.0 – 14.2

Day 36

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	55.6	43.4 – 67.3
Arm 2: NoV Vaccine Formulation A_2-Dose	74.2	62.0 – 84.2
Arm 3: NoV Vaccine Formulation B_1-Dose	65.6	52.7 – 77.1
Arm 4: NoV Vaccine Formulation B_2-Dose	89.4	79.4 – 95.6
Arm 5: NoV Vaccine Formulation A_1-Dose	60.9	38.5 – 80.3

Day 57

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	64.8	52.5 – 75.8
Arm 2: NoV Vaccine Formulation A_2-Dose	80.0	68.2 – 88.9
Arm 3: NoV Vaccine Formulation B_1-Dose	74.2	61.5 – 84.5
Arm 4: NoV Vaccine Formulation B_2-Dose	89.4	79.4 – 95.6
Arm 5: NoV Vaccine Formulation A_1-Dose	62.5	40.6 – 81.2

Day 211

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	33.8	23.0 – 46.0
Arm 2: NoV Vaccine Formulation A_2-Dose	57.6	44.8 – 69.7
Arm 3: NoV Vaccine Formulation B_1-Dose	54.7	41.7 – 67.2
Arm 4: NoV Vaccine Formulation B_2-Dose	57.6	44.8 – 69.7
Arm 5: NoV Vaccine Formulation A_1-Dose	26.1	10.2 – 48.4

Day 393

Group	Value	95% CI
Arm 1: NoV Vaccine Formulation A_1-Dose	25.7	16.0 – 37.6
Arm 2: NoV Vaccine Formulation A_2-Dose	50.0	37.2 – 62.8
Arm 3: NoV Vaccine Formulation B_1-Dose	41.3	29.0 – 54.4
Arm 4: NoV Vaccine Formulation B_2-Dose	47.7	35.1 – 60.5
Arm 5: NoV Vaccine Formulation A_1-Dose	30.4	13.2 – 52.9

Adverse events — posted to ClinicalTrials.gov

Time frame: All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: NoV Vaccine Formulation A_1-Dose

Serious: 7/76 (9%)

Deaths: 1/76

Arm 2: NoV Vaccine Formulation A_2-Dose

Serious: 9/74 (12%)

Deaths: 1/74

Arm 3: NoV Vaccine Formulation B_1-Dose

Serious: 17/72 (24%)

Deaths: 0/72

Arm 4: NoV Vaccine Formulation B_2-Dose

Serious: 9/72 (13%)

Deaths: 1/72

Arm 5: NoV Vaccine Formulation A_1-Dose

Serious: 0/25 (0%)

Deaths: 0/25

Serious adverse events (61 terms)

Reaction	System	Arm 1: NoV Vaccine Formula…	Arm 2: NoV Vaccine Formula…	Arm 3: NoV Vaccine Formula…	Arm 4: NoV Vaccine Formula…	Arm 5: NoV Vaccine Formula…
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Haemorrhagic anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Aortic valve stenosis	Cardiac disorders	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—
Aortic valve incompetence	Cardiac disorders	—	—	—	—	—
Atrial flutter	Cardiac disorders	—	—	—	—	—
Atrioventricular block complete	Cardiac disorders	—	—	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—
Stress cardiomyopathy	Cardiac disorders	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—
Vertigo positional	Ear and labyrinth disorders	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—
Complication associated with device	General disorders	—	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—	—
Bile duct stone	Hepatobiliary disorders	—	—	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Arm 1: NoV Vaccine Formula…	Arm 2: NoV Vaccine Formula…	Arm 3: NoV Vaccine Formula…	Arm 4: NoV Vaccine Formula…	Arm 5: NoV Vaccine Formula…
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Exposure to communicable disease	Injury, poisoning and procedural complications	—	—	—	—	—
Poor quality sleep	Nervous system disorders	—	—	—	—	—

Most-reported serious reactions: Atrial fibrillation, Hip fracture, Haemorrhagic anaemia, Aortic valve stenosis, Cardiac failure congestive, Acute coronary syndrome, Acute myocardial infarction, Aortic valve incompetence.

Data from ClinicalTrials.gov NCT02661490 adverse events section.

Sponsor's own description

The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Virus-like particle vaccines: immunology and formulation for clinical translation.
Donaldson B, Lateef Z, Walker GF, Young SL, et al · · 2018 · cited 108× · PMID 30173619 · DOI 10.1080/14760584.2018.1516552
Prospects and Challenges in the Development of a Norovirus Vaccine.
Cortes-Penfield NW, Ramani S, Estes MK, Atmar RL. · · 2017 · cited 71× · PMID 28756066 · DOI 10.1016/j.clinthera.2017.07.002
Norovirus Vaccine: Priorities for Future Research and Development.
Esposito S, Principi N. · · 2020 · cited 69× · PMID 32733458 · DOI 10.3389/fimmu.2020.01383
Progress on norovirus vaccine research: public health considerations and future directions.
Mattison CP, Cardemil CV, Hall AJ. · · 2018 · cited 65× · PMID 30092671 · DOI 10.1080/14760584.2018.1510327
Structure(s), function(s), and inhibition of the RNA-dependent RNA polymerase of noroviruses.
Deval J, Jin Z, Chuang YC, Kao CC. · · 2017 · cited 59× · PMID 28041960 · DOI 10.1016/j.virusres.2016.12.018
Norovirus replication, host interactions and vaccine advances.
Prasad BVV, Atmar RL, Ramani S, Palzkill T, et al · · 2025 · cited 33× · PMID 39824927 · DOI 10.1038/s41579-024-01144-9
Plant Viruses and Bacteriophage-Based Reagents for Diagnosis and Therapy.
Shukla S, Hu H, Cai H, Chan SK, et al · · 2020 · cited 27× · PMID 32991265 · DOI 10.1146/annurev-virology-010720-052252
Epidemiology and evolution of Norovirus in China.
Wei N, Ge J, Tan C, Song Y, et al · · 2021 · cited 20× · PMID 34495811 · DOI 10.1080/21645515.2021.1961465

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02661490 (US National Library of Medicine, public domain)
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: 18 May 2020

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/NCT02661490.

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