NCT02038907 (NOR-107) is a Phase 2 clinical trial of Hepatitis A Vaccine in Healthy Volunteers, sponsored by Takeda.

Who is sponsoring NCT02038907?

NCT02038907 is sponsored by Takeda.

What drugs are being tested in NCT02038907?

Interventions in NCT02038907: Hepatitis A Vaccine, Norovirus Bivalent VLP Vaccine.

What condition does NCT02038907 study?

NCT02038907 studies Healthy Volunteers, Norovirus, Prevention.

Is NCT02038907 still recruiting?

NCT02038907 is currently completed. Last updated 8 August 2017.

Are results published for NCT02038907?

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

Last reviewed 2017-08-08 · How we verify

NCT02038907: NOR-107

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 VLP Vaccine

Completed Phase 2 Results posted Last updated 8 August 2017

What this trial tests

Phase 2 trial testing Hepatitis A Vaccine in Healthy Volunteers in 420 participants. Completed in 19 June 2015.

Timeline

28 March 2014

Primary endpoint
19 June 2015

19 June 2015

Quick facts

Lead sponsor	Takeda
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	420
Start date	28 March 2014
Primary completion	19 June 2015
Estimated completion	19 June 2015
Sites	2 locations across Belgium

Drugs / interventions tested

Hepatitis A Vaccine — full drug profile →
Norovirus Bivalent VLP Vaccine — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Norovirus, Prevention — all drugs for Norovirus, Prevention →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 64, any sex, with Healthy Volunteers or 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 a Seroresponse (Pan-Ig ELISA) Primary · Baseline and Day 56

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	43.3	25.5 – 62.6
GI.1/GII.4 (15/50) - MPL (50)	62.1	42.3 – 79.3
GI.1/GII.4 (50/50) - MPL (50)	46.4	27.5 – 66.1
GI.1/GII.4 (15/15) - MPL (15)	35.5	19.2 – 54.6
GI.1/GII.4 (15/50) - MPL (15)	80.0	61.4 – 92.3
GI.1/GII.4 (50/50) - MPL (15)	67.7	48.6 – 83.3
GI.1/GII.4 (15/15)	30.0	14.7 – 49.4
GI.1/GII.4 (15/50)	62.5	43.7 – 78.9
GI.1/GII.4 (50/50)	42.9	24.5 – 62.8
GI.1/GII.4 (50/150)	66.7	47.2 – 82.7
GI.1/GII.4 (15/50) - Al(OH)3 (167)	46.2	26.6 – 66.6
GI.1/GII.4 (15/50) x2	71.4	51.3 – 86.8

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1 Primary · Days 1 through 7

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.

Pain

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	43.3
GI.1/GII.4 (15/50) - MPL (50)	33.3
GI.1/GII.4 (50/50) - MPL (50)	50.0
GI.1/GII.4 (15/15) - MPL (15)	32.3
GI.1/GII.4 (15/50) - MPL (15)	46.7
GI.1/GII.4 (50/50) - MPL (15)	38.7
GI.1/GII.4 (15/15)	40.0
GI.1/GII.4 (15/50)	53.1
GI.1/GII.4 (50/50)	44.8
GI.1/GII.4 (50/150)	53.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	48.3
GI.1/GII.4 (15/50) x2	46.4

Erythema

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	0
GI.1/GII.4 (50/150)	0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Induration

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	0
GI.1/GII.4 (50/150)	0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Swelling

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	3.4
GI.1/GII.4 (50/150)	0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2 Primary · Days 28 through 34

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.

Pain

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	60.0
GI.1/GII.4 (15/50) - MPL (50)	36.7
GI.1/GII.4 (50/50) - MPL (50)	66.7
GI.1/GII.4 (15/15) - MPL (15)	51.6
GI.1/GII.4 (15/50) - MPL (15)	53.3
GI.1/GII.4 (50/50) - MPL (15)	58.1
GI.1/GII.4 (15/15)	33.3
GI.1/GII.4 (15/50)	43.8
GI.1/GII.4 (50/50)	48.3
GI.1/GII.4 (50/150)	46.7
GI.1/GII.4 (15/50) - Al(OH)3 (167)	34.5
GI.1/GII.4 (15/50) x2	32.1

Erythema

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	3.3
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	3.4
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Induration

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	3.3
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	6.7
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	3.4
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Swelling

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	3.3
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	3.2
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	3.2
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	6.9
GI.1/GII.4 (50/150)	0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0
GI.1/GII.4 (15/50) x2	0

Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1 Primary · Days 1 through 7

Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.

Headache

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	20.0
GI.1/GII.4 (15/50) - MPL (50)	26.7
GI.1/GII.4 (50/50) - MPL (50)	3.3
GI.1/GII.4 (15/15) - MPL (15)	19.4
GI.1/GII.4 (15/50) - MPL (15)	16.7
GI.1/GII.4 (50/50) - MPL (15)	12.9
GI.1/GII.4 (15/15)	13.3
GI.1/GII.4 (15/50)	25.0
GI.1/GII.4 (50/50)	27.6
GI.1/GII.4 (50/150)	20.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	13.8
GI.1/GII.4 (15/50) x2	17.9

Fatigue

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	23.3
GI.1/GII.4 (15/50) - MPL (50)	23.3
GI.1/GII.4 (50/50) - MPL (50)	16.7
GI.1/GII.4 (15/15) - MPL (15)	19.4
GI.1/GII.4 (15/50) - MPL (15)	10.0
GI.1/GII.4 (50/50) - MPL (15)	12.9
GI.1/GII.4 (15/15)	13.3
GI.1/GII.4 (15/50)	15.6
GI.1/GII.4 (50/50)	17.2
GI.1/GII.4 (50/150)	20.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	24.1
GI.1/GII.4 (15/50) x2	25.0

Myalgia

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	20.0
GI.1/GII.4 (15/50) - MPL (50)	6.7
GI.1/GII.4 (50/50) - MPL (50)	13.3
GI.1/GII.4 (15/15) - MPL (15)	6.5
GI.1/GII.4 (15/50) - MPL (15)	3.3
GI.1/GII.4 (50/50) - MPL (15)	9.7
GI.1/GII.4 (15/15)	6.7
GI.1/GII.4 (15/50)	18.8
GI.1/GII.4 (50/50)	10.3
GI.1/GII.4 (50/150)	10.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	17.2
GI.1/GII.4 (15/50) x2	10.7

Arthralgia

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	3.3
GI.1/GII.4 (50/50) - MPL (50)	6.7
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	3.3
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	3.3
GI.1/GII.4 (15/50)	6.3
GI.1/GII.4 (50/50)	6.9
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	3.6

Vomiting

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	3.3
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	3.2
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	0
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	0

Diarrhea

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	23.3
GI.1/GII.4 (50/50) - MPL (50)	3.3
GI.1/GII.4 (15/15) - MPL (15)	16.1
GI.1/GII.4 (15/50) - MPL (15)	20.0
GI.1/GII.4 (50/50) - MPL (15)	6.5
GI.1/GII.4 (15/15)	13.3
GI.1/GII.4 (15/50)	12.5
GI.1/GII.4 (50/50)	13.8
GI.1/GII.4 (50/150)	10.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	6.9
GI.1/GII.4 (15/50) x2	7.1

Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2 Primary · Days 28 through 34

Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.

Headache

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	13.3
GI.1/GII.4 (15/50) - MPL (50)	13.3
GI.1/GII.4 (50/50) - MPL (50)	13.3
GI.1/GII.4 (15/15) - MPL (15)	22.6
GI.1/GII.4 (15/50) - MPL (15)	23.3
GI.1/GII.4 (50/50) - MPL (15)	16.1
GI.1/GII.4 (15/15)	10.0
GI.1/GII.4 (15/50)	21.9
GI.1/GII.4 (50/50)	20.7
GI.1/GII.4 (50/150)	10.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	13.8
GI.1/GII.4 (15/50) x2	14.3

Fatigue

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	16.7
GI.1/GII.4 (15/50) - MPL (50)	13.3
GI.1/GII.4 (50/50) - MPL (50)	20.0
GI.1/GII.4 (15/15) - MPL (15)	12.9
GI.1/GII.4 (15/50) - MPL (15)	10.0
GI.1/GII.4 (50/50) - MPL (15)	12.9
GI.1/GII.4 (15/15)	10.0
GI.1/GII.4 (15/50)	18.8
GI.1/GII.4 (50/50)	17.2
GI.1/GII.4 (50/150)	13.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	13.8
GI.1/GII.4 (15/50) x2	7.1

Myalgia

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	13.3
GI.1/GII.4 (15/50) - MPL (50)	3.3
GI.1/GII.4 (50/50) - MPL (50)	13.3
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	13.3
GI.1/GII.4 (50/50) - MPL (15)	12.9
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	6.3
GI.1/GII.4 (50/50)	6.9
GI.1/GII.4 (50/150)	0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	10.3
GI.1/GII.4 (15/50) x2	7.1

Arthralgia

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	3.3
GI.1/GII.4 (50/50) - MPL (50)	3.3
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	3.3
GI.1/GII.4 (50/50) - MPL (15)	3.2
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	3.1
GI.1/GII.4 (50/50)	0
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	3.6

Vomiting

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	0
GI.1/GII.4 (15/15) - MPL (15)	0
GI.1/GII.4 (15/50) - MPL (15)	0
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	0
GI.1/GII.4 (15/50)	0
GI.1/GII.4 (50/50)	0
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	0

Diarrhea

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	3.3
GI.1/GII.4 (15/50) - MPL (50)	10.0
GI.1/GII.4 (50/50) - MPL (50)	16.7
GI.1/GII.4 (15/15) - MPL (15)	12.9
GI.1/GII.4 (15/50) - MPL (15)	16.7
GI.1/GII.4 (50/50) - MPL (15)	9.7
GI.1/GII.4 (15/15)	6.7
GI.1/GII.4 (15/50)	15.6
GI.1/GII.4 (50/50)	17.2
GI.1/GII.4 (50/150)	10.0
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	7.1

Oral Body Temperature Within 7 Days After Dose 1 Primary · Days 1 through 7

Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	36.54	± 0.294
GI.1/GII.4 (15/50) - MPL (50)	36.76	± 0.376
GI.1/GII.4 (50/50) - MPL (50)	36.66	± 0.345
GI.1/GII.4 (15/15) - MPL (15)	36.71	± 0.260
GI.1/GII.4 (15/50) - MPL (15)	36.65	± 0.388
GI.1/GII.4 (50/50) - MPL (15)	36.67	± 0.255
GI.1/GII.4 (15/15)	36.74	± 0.323
GI.1/GII.4 (15/50)	36.63	± 0.366
GI.1/GII.4 (50/50)	36.52	± 0.405
GI.1/GII.4 (50/150)	36.77	± 0.341
GI.1/GII.4 (15/50) - Al(OH)3 (167)	36.71	± 0.404
GI.1/GII.4 (15/50) x2	36.61	± 0.368

Oral Body Temperature Within 7 Days After Dose 2 Primary · Days 28 through 34

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	36.54	± 0.282
GI.1/GII.4 (15/50) - MPL (50)	36.76	± 0.301
GI.1/GII.4 (50/50) - MPL (50)	36.68	± 0.351
GI.1/GII.4 (15/15) - MPL (15)	36.75	± 0.466
GI.1/GII.4 (15/50) - MPL (15)	36.60	± 0.286
GI.1/GII.4 (50/50) - MPL (15)	36.72	± 0.317
GI.1/GII.4 (15/15)	36.71	± 0.394
GI.1/GII.4 (15/50)	36.64	± 0.342
GI.1/GII.4 (50/50)	36.59	± 0.463
GI.1/GII.4 (50/150)	36.73	± 0.293
GI.1/GII.4 (15/50) - Al(OH)3 (167)	36.68	± 0.345
GI.1/GII.4 (15/50) x2	36.56	± 0.351

Percentage of Participants With Unsolicited Adverse Events (AEs) Primary · Day 1 up to Day 56

Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	56.7
GI.1/GII.4 (15/50) - MPL (50)	60.0
GI.1/GII.4 (50/50) - MPL (50)	53.3
GI.1/GII.4 (15/15) - MPL (15)	45.2
GI.1/GII.4 (15/50) - MPL (15)	43.3
GI.1/GII.4 (50/50) - MPL (15)	54.8
GI.1/GII.4 (15/15)	43.3
GI.1/GII.4 (15/50)	62.5
GI.1/GII.4 (50/50)	69.0
GI.1/GII.4 (50/150)	43.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	48.3
GI.1/GII.4 (15/50) x2	50.0

Percentage of Participants With Serious Adverse Events (SAEs) Primary · Day 1 up to Day 393

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.

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	6.7
GI.1/GII.4 (15/50) - MPL (50)	0
GI.1/GII.4 (50/50) - MPL (50)	16.7
GI.1/GII.4 (15/15) - MPL (15)	6.5
GI.1/GII.4 (15/50) - MPL (15)	3.3
GI.1/GII.4 (50/50) - MPL (15)	0
GI.1/GII.4 (15/15)	10.0
GI.1/GII.4 (15/50)	9.4
GI.1/GII.4 (50/50)	3.4
GI.1/GII.4 (50/150)	3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	3.4
GI.1/GII.4 (15/50) x2	7.1

Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA) Secondary · Baseline and Days 28, 208 and 393

D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0	0.0 – 11.6
GI.1/GII.4 (15/50) - MPL (50)	0	0.0 – 11.6
GI.1/GII.4 (50/50) - MPL (50)	0	0.0 – 11.9
GI.1/GII.4 (15/15) - MPL (15)	0	0.0 – 11.2
GI.1/GII.4 (15/50) - MPL (15)	0	0.0 – 11.6
GI.1/GII.4 (50/50) - MPL (15)	0	0.0 – 11.2
GI.1/GII.4 (15/15)	0	0.0 – 11.6
GI.1/GII.4 (15/50)	0	0.0 – 10.9
GI.1/GII.4 (50/50)	0	0.0 – 12.3
GI.1/GII.4 (50/150)	0	0.0 – 11.6
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0	0.0 – 12.8
GI.1/GII.4 (15/50) x2	71.4	51.3 – 86.8

D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	10.0	2.1 – 26.5
GI.1/GII.4 (15/50) - MPL (50)	17.2	5.8 – 35.8
GI.1/GII.4 (50/50) - MPL (50)	10.0	2.1 – 26.5
GI.1/GII.4 (15/15) - MPL (15)	19.4	7.5 – 37.5
GI.1/GII.4 (15/50) - MPL (15)	20.0	7.7 – 38.6
GI.1/GII.4 (50/50) - MPL (15)	20.0	7.7 – 38.6
GI.1/GII.4 (15/15)	6.7	0.8 – 22.1
GI.1/GII.4 (15/50)	34.4	18.6 – 53.2
GI.1/GII.4 (50/50)	17.2	5.8 – 35.8
GI.1/GII.4 (50/150)	23.3	9.9 – 42.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	14.8	4.2 – 33.7
GI.1/GII.4 (15/50) x2	32.1	15.9 – 52.4

D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	17.2	5.8 – 35.8
GI.1/GII.4 (15/50) - MPL (50)	20.7	8.0 – 39.7
GI.1/GII.4 (50/50) - MPL (50)	13.3	3.8 – 30.7
GI.1/GII.4 (15/15) - MPL (15)	16.1	5.5 – 33.7
GI.1/GII.4 (15/50) - MPL (15)	10.0	2.1 – 26.5
GI.1/GII.4 (50/50) - MPL (15)	13.8	3.9 – 31.7
GI.1/GII.4 (15/15)	10.3	2.2 – 27.4
GI.1/GII.4 (15/50)	15.6	5.3 – 32.8
GI.1/GII.4 (50/50)	6.9	0.8 – 22.8
GI.1/GII.4 (50/150)	13.3	3.8 – 30.7
GI.1/GII.4 (15/50) - Al(OH)3 (167)	7.4	0.9 – 24.3
GI.1/GII.4 (15/50) x2	21.4	8.3 – 41.0

Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA) Secondary · Baseline and Days 28, 56, 208 and 393

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0	0.0 – 11.6
GI.1/GII.4 (15/50) - MPL (50)	0	0.0 – 11.9
GI.1/GII.4 (50/50) - MPL (50)	0	0.0 – 12.8
GI.1/GII.4 (15/15) - MPL (15)	6.9	0.8 – 22.8
GI.1/GII.4 (15/50) - MPL (15)	0	0.0 – 11.6
GI.1/GII.4 (50/50) - MPL (15)	0	0.0 – 11.2
GI.1/GII.4 (15/15)	0	0.0 – 11.6
GI.1/GII.4 (15/50)	0	0.0 – 10.9
GI.1/GII.4 (50/50)	0	0.0 – 12.8
GI.1/GII.4 (50/150)	0	0.0 – 11.6
GI.1/GII.4 (15/50) - Al(OH)3 (167)	4.2	0.1 – 21.1
GI.1/GII.4 (15/50) x2	85.7	67.3 – 96.0

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	80.0	61.4 – 92.3
GI.1/GII.4 (15/50) - MPL (50)	89.7	72.6 – 97.8
GI.1/GII.4 (50/50) - MPL (50)	100.0	87.7 – 100.0
GI.1/GII.4 (15/15) - MPL (15)	89.7	72.6 – 97.8
GI.1/GII.4 (15/50) - MPL (15)	93.3	77.9 – 99.2
GI.1/GII.4 (50/50) - MPL (15)	96.8	83.3 – 99.9
GI.1/GII.4 (15/15)	86.7	69.3 – 96.2
GI.1/GII.4 (15/50)	87.5	71.0 – 96.5
GI.1/GII.4 (50/50)	92.9	76.5 – 99.1
GI.1/GII.4 (50/150)	90.0	73.5 – 97.9
GI.1/GII.4 (15/50) - Al(OH)3 (167)	83.3	62.6 – 95.3
GI.1/GII.4 (15/50) x2	85.7	67.3 – 96.0

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	60.0	40.6 – 77.3
GI.1/GII.4 (15/50) - MPL (50)	65.5	45.7 – 82.1
GI.1/GII.4 (50/50) - MPL (50)	67.9	47.6 – 84.1
GI.1/GII.4 (15/15) - MPL (15)	72.4	52.8 – 87.3
GI.1/GII.4 (15/50) - MPL (15)	70.0	50.6 – 85.3
GI.1/GII.4 (50/50) - MPL (15)	73.3	54.1 – 87.7
GI.1/GII.4 (15/15)	66.7	47.2 – 82.7
GI.1/GII.4 (15/50)	62.5	43.7 – 78.9
GI.1/GII.4 (50/50)	85.7	67.3 – 96.0
GI.1/GII.4 (50/150)	60.0	40.6 – 77.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)	54.2	32.8 – 74.4
GI.1/GII.4 (15/50) x2	71.4	51.3 – 86.8

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	55.2	35.7 – 73.6
GI.1/GII.4 (15/50) - MPL (50)	46.4	27.5 – 66.1
GI.1/GII.4 (50/50) - MPL (50)	67.9	47.6 – 84.1
GI.1/GII.4 (15/15) - MPL (15)	69.0	49.2 – 84.7
GI.1/GII.4 (15/50) - MPL (15)	63.3	43.9 – 80.1
GI.1/GII.4 (50/50) - MPL (15)	65.5	45.7 – 82.1
GI.1/GII.4 (15/15)	55.2	35.7 – 73.6
GI.1/GII.4 (15/50)	53.1	34.7 – 70.9
GI.1/GII.4 (50/50)	82.1	63.1 – 93.9
GI.1/GII.4 (50/150)	43.3	25.5 – 62.6
GI.1/GII.4 (15/50) - Al(OH)3 (167)	45.8	25.6 – 67.2
GI.1/GII.4 (15/50) x2	64.3	44.1 – 81.4

Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA) Secondary · Baseline and Days 28, 56, 208 and 393

The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	0	0.0 – 11.6
GI.1/GII.4 (15/50) - MPL (50)	0	0.0 – 11.9
GI.1/GII.4 (50/50) - MPL (50)	0	0.0 – 12.8
GI.1/GII.4 (15/15) - MPL (15)	0	0.0 – 11.9
GI.1/GII.4 (15/50) - MPL (15)	0	0.0 – 11.6
GI.1/GII.4 (50/50) - MPL (15)	0	0.0 – 11.2
GI.1/GII.4 (15/15)	3.3	0.1 – 17.2
GI.1/GII.4 (15/50)	3.1	0.1 – 16.2
GI.1/GII.4 (50/50)	0	0.0 – 12.8
GI.1/GII.4 (50/150)	3.3	0.1 – 17.2
GI.1/GII.4 (15/50) - Al(OH)3 (167)	0	0.0 – 14.2
GI.1/GII.4 (15/50) x2	78.6	59.0 – 91.7

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	50.0	31.3 – 68.7
GI.1/GII.4 (15/50) - MPL (50)	65.5	45.7 – 82.1
GI.1/GII.4 (50/50) - MPL (50)	46.4	27.5 – 66.1
GI.1/GII.4 (15/15) - MPL (15)	41.4	23.5 – 61.1
GI.1/GII.4 (15/50) - MPL (15)	83.3	65.3 – 94.4
GI.1/GII.4 (50/50) - MPL (15)	71.0	52.0 – 85.8
GI.1/GII.4 (15/15)	33.3	17.3 – 52.8
GI.1/GII.4 (15/50)	71.9	53.3 – 86.3
GI.1/GII.4 (50/50)	42.9	24.5 – 62.8
GI.1/GII.4 (50/150)	73.3	54.1 – 87.7
GI.1/GII.4 (15/50) - Al(OH)3 (167)	54.2	32.8 – 74.4
GI.1/GII.4 (15/50) x2	78.6	59.0 – 91.7

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	16.7	5.6 – 34.7
GI.1/GII.4 (15/50) - MPL (50)	27.6	12.7 – 47.2
GI.1/GII.4 (50/50) - MPL (50)	7.1	0.9 – 23.5
GI.1/GII.4 (15/15) - MPL (15)	27.6	12.7 – 47.2
GI.1/GII.4 (15/50) - MPL (15)	36.7	19.9 – 56.1
GI.1/GII.4 (50/50) - MPL (15)	23.3	9.9 – 42.3
GI.1/GII.4 (15/15)	16.7	5.6 – 34.7
GI.1/GII.4 (15/50)	46.9	29.1 – 65.3
GI.1/GII.4 (50/50)	14.3	4.0 – 32.7
GI.1/GII.4 (50/150)	30.0	14.7 – 49.4
GI.1/GII.4 (15/50) - Al(OH)3 (167)	16.7	4.7 – 37.4
GI.1/GII.4 (15/50) x2	35.7	18.6 – 55.9

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

Group	Value	95% CI
GI.1/GII.4 (15/15) - MPL (50)	20.7	8.0 – 39.7
GI.1/GII.4 (15/50) - MPL (50)	32.1	15.9 – 52.4
GI.1/GII.4 (50/50) - MPL (50)	10.7	2.3 – 28.2
GI.1/GII.4 (15/15) - MPL (15)	27.6	12.7 – 47.2
GI.1/GII.4 (15/50) - MPL (15)	20.0	7.7 – 38.6
GI.1/GII.4 (50/50) - MPL (15)	17.2	5.8 – 35.8
GI.1/GII.4 (15/15)	17.2	5.8 – 35.8
GI.1/GII.4 (15/50)	21.9	9.3 – 40.0
GI.1/GII.4 (50/50)	10.7	2.3 – 28.2
GI.1/GII.4 (50/150)	13.3	3.8 – 30.7
GI.1/GII.4 (15/50) - Al(OH)3 (167)	8.3	1.0 – 27.0
GI.1/GII.4 (15/50) x2	28.6	13.2 – 48.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GI.1/GII.4 (15/15) - MPL (50)

Serious: 2/30 (7%)

Deaths: —

GI.1/GII.4 (15/50) - MPL (50)

Serious: 0/30 (0%)

Deaths: —

GI.1/GII.4 (50/50) - MPL (50)

Serious: 5/30 (17%)

Deaths: —

GI.1/GII.4 (15/15) - MPL (15)

Serious: 2/31 (6%)

Deaths: —

GI.1/GII.4 (15/50) - MPL (15)

Serious: 1/30 (3%)

Deaths: —

GI.1/GII.4 (50/50) - MPL (15)

Serious: 0/31 (0%)

Deaths: —

GI.1/GII.4 (15/15)

Serious: 3/30 (10%)

Deaths: —

GI.1/GII.4 (15/50)

Serious: 3/32 (9%)

Deaths: —

GI.1/GII.4 (50/50)

Serious: 1/29 (3%)

Deaths: —

GI.1/GII.4 (50/150)

Serious: 1/30 (3%)

Deaths: —

GI.1/GII.4 (15/50) - Al(OH)3 (167)

Serious: 1/29 (3%)

Deaths: —

GI.1/GII.4 (15/50) x2

Serious: 2/28 (7%)

Deaths: —

GI.1/GII.4 (50/150) x2

Serious: 1/29 (3%)

Deaths: —

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Serious: 1/31 (3%)

Deaths: —

Serious adverse events (25 terms)

Reaction	System	GI.1/GII.4 (15/15) - MPL (…	GI.1/GII.4 (15/50) - MPL (…	GI.1/GII.4 (50/50) - MPL (…	GI.1/GII.4 (15/15) - MPL (…	GI.1/GII.4 (15/50) - MPL (…	GI.1/GII.4 (50/50) - MPL (…	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH…	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH…
Chondropathy	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Foot deformity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis bacterial	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leptospirosis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Meningitis aseptic	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Compression fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tendon injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intestinal polyp	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Large intestinal polyp	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Biliary colic	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Goitre	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Major depression	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pharyngeal abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	GI.1/GII.4 (15/15) - MPL (…	GI.1/GII.4 (15/50) - MPL (…	GI.1/GII.4 (50/50) - MPL (…	GI.1/GII.4 (15/15) - MPL (…	GI.1/GII.4 (15/50) - MPL (…	GI.1/GII.4 (50/50) - MPL (…	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH…	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Chondropathy, Foot deformity, Intervertebral disc protrusion, Osteoarthritis, Appendicitis, Erysipelas, Gastroenteritis bacterial, Leptospirosis.

Data from ClinicalTrials.gov NCT02038907 adverse events section.

Sponsor's own description

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.

Publications & conference data

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

Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial.
Leroux-Roels G, Cramer JP, Mendelman PM, Sherwood J, et al · · 2018 · cited 54× · PMID 29140444 · DOI 10.1093/infdis/jix572
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
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
6-Valent Virus-Like Particle-Based Vaccine Induced Potent and Sustained Immunity Against Noroviruses in Mice.
Hou W, Lv L, Wang Y, Xing M, et al · · 2022 · cited 8× · PMID 35711416 · DOI 10.3389/fimmu.2022.906275
Unraveling the interplay between norovirus infection, gut microbiota, and novel antiviral approaches: a comprehensive review.
Bai GH, Tsai MC, Lin SC, Hsu YH, et al · · 2023 · cited 7× · PMID 37485533 · DOI 10.3389/fmicb.2023.1212582
Virus-like Particles for TEM Regulation and Antitumor Therapy.
Yang Z, Chi Y, Bao J, Zhao X, et al · · 2022 · cited 4× · PMID 36547564 · DOI 10.3390/jfb13040304
Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults.
Leroux-Roels G, Atmar RL, Cramer JP, Escudero I, et al · · 2025 · cited 3× · PMID 39852862 · DOI 10.3390/vaccines13010082

Verify or expand the search:

Other trials of Hepatitis A Vaccine

Trials testing the same drug.

NCT03231605 — Comparative Immunogenicity Study of Two Hepatitis A Vaccines · Phase 4 · unknown

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

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 NCT02038907 (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: 8 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/NCT02038907.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02038907: NOR-107

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (25 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Hepatitis A Vaccine

Other recruiting trials for Healthy Volunteers

Other Takeda trials

Verify against primary sources