NorovirusPhase 2NCT02153112

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children

A Phase 2 study testing GI.1/GII.4 (15/15), GI.1/GII.4 (15/50) and GI.1/GII.4 (50/50) in people with Norovirus, run by Takeda at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children. Read more about this study

Who is it for?: Ages 6 weeks to 8 yearsHealthy volunteers can take part
Conditions the study is for: Norovirus
What is being tested?: GI.1/GII.4 (15/15), GI.1/GII.4 (15/50) and GI.1/GII.4 (50/50)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 840 participants
Where: 12 sitesin 3 countries
Study dates: 23 Jun 2015to 20 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male and female participants aged between 6 weeks and less than 9 years at the time of enrollment.
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.
Participants legally authorized representative (LAR) signs and dates a written, informed consent form (ICF) 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. An assent will also be obtained according to age-appropriate country-specific regulations.
Participants who can comply with trial procedures and are available for the duration of the trial.

Who cannot join

Participants with a clinically significant active infection (as assessed by the investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the intended date of vaccination.
Have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
Known hypersensitivity or allergy to investigational vaccine (including excipients of the investigational vaccines).
Participants with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the ability to participate in the trial.
Has a history of any progressive or severe neurologic disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including the following:

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Children <18 months of age with history of repeated episodes of acute otitis media (AOM) in the first 6 months of life (AOM defined as a bulging tympanic membrane) and not to be confused with otitis media with effusion (OME).
Chronic use of oral steroids (equivalent to 20 mg/day prednisone for ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1.
Receipt of immunostimulants within 60 days prior to Day 1.
Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.
Receipt of immunosuppressive therapy within 6 months prior to Day 1.
Human immunodeficiency virus (HIV) infection or HIV-related disease.
Chronic Hepatitis B or C infection.
Heritable immunodeficiency.
Abnormalities of splenic or thymic function.
Has a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
Has any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
Is participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial.
Are first degree relatives of individuals involved in trial conduct.
Has a history of autoimmune disease.

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

Finland9 sites

Espoon Rokotetutkimusklinikka
Espoo, 2230
Etela-Helsingin Rokotetutkimusklinikka
Helsinki, 00100
Ita-Helsingin Rokotetutkimusklinikka
Helsinki, 90220
Jarvenpaan Rokotetutkimusklinikka
Jarvenpaan, 04400
Oulun Rokotetutkimusklinikka
Oulu, 33100
Porin Rokotetutkimusklinikka
Pori, 28100
Seinajoen Rokotetutkimusklinikka
Seinäjoki, 60100
Tampere Vaccine Research Clinic
Tampere, 33100
Turun Rokotetutkimusklinikka
Turku, 20520

Other trials in Finland

Panama2 sites

CEVAXIN Plaza Carolina - Ciudad de Panama
Panama City
CEVAXIN
Panama City

Other trials in Panama

Colombia1 site

Centro de Estudios em Infectologia Pediatrica SAS
Cali, San Fernando

Other trials in Colombia

About this study

Official title: A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Combined With Aluminum Hydroxide Adjuvant in Children, Toddlers, and Infants

Read the detailed description

The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine with aluminum hydroxide. The norovirus vaccine is being tested to assess different formulations of the vaccine that will then be further developed. This study will look at the number of antibodies to norovirus formed in children, toddlers and infants who are administered different formulations of the norovirus vaccine.

The study enrolled 840 patients. Participants will be randomly assigned (by chance) to one of ten treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

All participants in Cohort 1 will be vaccinated on Day 1 and Day 29 of the study, and all participants in Cohort 2 will be vaccinated on Day 1, Day 56, and Day 112. All treatment groups in Cohort 1 will receive either one dose of the norovirus vaccine, or two doses. One treatment group in Cohort 2 will receive 2 doses of the norovirus vaccine, and the other group will receive 3. In order to keep the treatment undisclosed to the participant and the doctor in Cohort 1, those randomized to the one-dose groups will receive the norovirus vaccine on Day 1, followed by a dose of placebo vaccine on Day 29. In order to keep the treatment arms undisclosed to the participant and the doctor in Cohort 2, those randomized to the two-dose groups will receive the norovirus vaccine on Day 1 and Day 56, followed by a dose of placebo vaccine on Day 112. Placebo vaccine is saline solution. Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after each vaccination.

This multi-center trial will be conducted in Finland, Panama, and Colombia. The overall time to participate in this study is up to 210 days for participants in Cohort 1 and up to 293 Days for participants in Cohort 2. Participants in Cohort 1 will make 6 visits to the clinic, and participants in Cohort 2 will make 10 visits to the clinic.

Conditions: Norovirus
Being tested: GI.1/GII.4 (15/15), GI.1/GII.4 (15/50), GI.1/GII.4 (50/50), GI.1/GII.4 (50/150), Placebo
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GI.1/GII.4 (15/15)Biological
Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
GI.1/GII.4 (15/50)Biological
Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
GI.1/GII.4 (50/50)Biological
Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
GI.1/GII.4 (50/150)Biological
Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
PlaceboDrug
Placebo saline solution

Study groups in NCT02153112
Study group	Role	What they receive
Cohort 1, Group 1: 1 Dose	Experimental	Children 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150); Drug: Placebo
Cohort 1, Group 1: 2 Doses	Experimental	Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150)
Cohort 1, Group 2: 1 Dose	Experimental	Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150); Drug: Placebo
Cohort 1, Group 2: 2 Doses	Experimental	Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150)
Cohort 1, Group 2a: 1 Dose	Experimental	Children 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150); Drug: Placebo
Cohort 1, Group 2a: 2 Doses	Experimental	Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150)
Cohort 1, Group 3: 1 Dose	Experimental	Toddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150); Drug: Placebo
Cohort 1, Group 3: 2 Doses	Experimental	Toddlers 6 months to <1 year of age will receive 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150)
Cohort 2, Group 4: 2 Doses	Experimental	Infants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150); Drug: Placebo
Cohort 2, Group 4: 3 Doses	Experimental	Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112. Receives: Biological: GI.1/GII.4 (15/15); Biological: GI.1/GII.4 (15/50); Biological: GI.1/GII.4 (50/50); Biological: GI.1/GII.4 (50/150)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1
Seroresponse was defined as 4-fold rise or greater at Day 57 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).
Measured: Day 57
Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 2
Seroresponse was defined as 4-fold rise or greater at Day 140 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).
Measured: Day 140
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 3 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 4 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 5 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 6 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Measured: Day 7 after either of the vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination
Systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to <9 years; and irritability/fussiness, drowsiness, loss of appetite, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 6 weeks to <4 years on the day of vaccination and daily through Day 7 after each vaccination.
Measured: Days 1 through 7 after each vaccination given on Days 1, 29, 56 or 112
Body Temperature Through Day 7 Following Either Vaccination
Body temperature measurement was performed using the thermometer provided by the site through Day 7 after each vaccination. The highest body temperature observed each day was recorded on the Diary Card. Body temperature is categorized as 1) Any (temperature 38°C or higher), 2) 38°C - <38.5°C, 3) 38.5°C - <39°C, 4) 39°C - <39.5°C, 5) 39.5°C - <40°C, 6) 40°C or higher. Number of participants with the particular body temperature is reported within the pre-defined categories.
Measured: Post-vaccination approximately 30 minutes and 6 hours later, then daily through Day 7 after each vaccination given on Days 1, 29, 56 or 112
Percentage of Participants With at Least One Unsolicited AE Following Either Vaccination Dose
Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
Measured: Unsolicited AEs were collected within 28 days of all vaccinations (Day 1 to 57 for Cohort 1 and Day 1 to 140 for Cohort 2)
Percentage of Participants With Serious Adverse Events (SAEs)
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.
Measured: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293

Secondary outcomes (14)

Percentage of Participants With a Seroresponse for GI.1 Virus-Like Particle (VLP) (Pan-Ig ELISA)
Seroresponse was defined as 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).
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a Seroresponse for GII.4 Virus-Like Particle (VLP) (Pan-Ig ELISA)
Seroresponse was defined as 4-fold rise or greater 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).
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP (HBGA)
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 histoblood group antigen (HBGA) binding assay.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
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 HBGA binding assay.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)
Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Measured: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.
Measured: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 201520 Jun 2018

First posted2 Jun 2014 (estimated)
Study start23 Jun 2015
Primary completion20 Jun 2018
Study completion20 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NorovirusStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 840 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02153112
Sponsor's protocol ID: NOR-202
Other IDs: 2014-000778-20, U1111-1154-9733, 2014
Status last verified: Dec 2018
First submitted: 29 May 2014
Last updated: 1 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Lopez P, Lopez-Medina E, Saez-Llorens X, deAntonio R, Masuda T, Mendelman PM, Sherwood J, Baehner F, Borkowski A. Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2204787. doi: 10.1080/21645515.2023.2204787. Epub 2023 May 4.
PubMed 37140558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Norovirus trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Combined With Aluminum Hydroxide Adjuvant in Children, Toddlers, and Infants
ClinicalTrials.gov ID: NCT02153112
Acronym / sponsor ID: NOR-202
Conditions: Norovirus
Keywords: Drug therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 840 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 23 Jun 2015 (actual)
Primary completion: 20 Jun 2018 (actual)
Study completion: 20 Jun 2018 (actual)
First posted: 2 Jun 2014 (estimated)
Results: Posted 1 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Cohort 1, Group 1: 1 Dose	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150), Drug: PlaceboChildren 4 to <9 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent virus-like particle (VLP) vaccine, intramuscularly (IM) and 500 µg aluminum hydroxide on Day 1, followed by placebo matching norovirus bivalent VLP vaccine IM on Day 29.
Cohort 1, Group 1: 2 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150)Children 4 to <9 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide IM on Days 1 and 29.
Cohort 1, Group 2: 1 Dose	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150), Drug: PlaceboChildren 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 29.
Cohort 1, Group 2: 2 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150)Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
Cohort 1, Group 2a: 1 Dose	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150), Drug: PlaceboChildren 1 to <4 years of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
Cohort 1, Group 2a: 2 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150)Children 1 to <4 years of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
Cohort 1, Group 3: 1 Dose	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150), Drug: PlaceboToddlers 6 months to <1 year of age received one dose of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Day 1, followed by placebo matching norovirus bivalent VLP vaccine, IM on Day 29.
Cohort 1, Group 3: 2 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150)Toddlers 6 months to <1 year of age will receive 2 doses either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 29.
Cohort 2, Group 4: 2 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150), Drug: PlaceboInfants 6 weeks to <6 months of age received 2 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) formulations of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1 and 56, followed by placebo-matching norovirus bivalent VLP vaccine, IM on Day 112.
Cohort 2, Group 4: 3 Doses	Experimental	Biological: GI.1/GII.4 (15/15), Biological: GI.1/GII.4 (15/50), Biological: GI.1/GII.4 (50/50), Biological: GI.1/GII.4 (50/150)Infants 6 weeks to <6 months of age received 3 doses of either of the 4 formulations (15 µg of GI.1 norovirus VLP and 15 µg GII.4/GI.1/GII.4 (15 μg/50 μg)/GI.1/GII.4 (50 μg/50 μg) or GI.1/GII.4 (50 μg/150 μg) of the norovirus bivalent VLP vaccine and 500 µg aluminum hydroxide, IM on Days 1, 56 and 112.

Who may qualify

Ages: 6 weeks to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male and female participants aged between 6 weeks and less than 9 years at the time of enrollment.
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.
Participants legally authorized representative (LAR) signs and dates a written, informed consent form (ICF) 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. An assent will also be obtained according to age-appropriate country-specific regulations.
Participants who can comply with trial procedures and are available for the duration of the trial.

Key exclusion criteria (22 listed)

Participants with a clinically significant active infection (as assessed by the investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the intended date of vaccination.
Have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
Known hypersensitivity or allergy to investigational vaccine (including excipients of the investigational vaccines).
Participants with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the ability to participate in the trial.
Has a history of any progressive or severe neurologic disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barré syndrome).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GI.1/GII.4 (15/15)Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection	Biological	Cohort 1, Group 1: 1 Dose, Cohort 1, Group 1: 2 Doses, Cohort 1, Group 2: 1 Dose, Cohort 1, Group 2: 2 Doses, Cohort 1, Group 2a: 1 Dose, Cohort 1, Group 2a: 2 Doses, Cohort 1, Group 3: 1 Dose, Cohort 1, Group 3: 2 Doses, Cohort 2, Group 4: 2 Doses, Cohort 2, Group 4: 3 Doses
GI.1/GII.4 (15/50)Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection	Biological	Cohort 1, Group 1: 1 Dose, Cohort 1, Group 1: 2 Doses, Cohort 1, Group 2: 1 Dose, Cohort 1, Group 2: 2 Doses, Cohort 1, Group 2a: 1 Dose, Cohort 1, Group 2a: 2 Doses, Cohort 1, Group 3: 1 Dose, Cohort 1, Group 3: 2 Doses, Cohort 2, Group 4: 2 Doses, Cohort 2, Group 4: 3 Doses
GI.1/GII.4 (50/50)Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection	Biological	Cohort 1, Group 1: 1 Dose, Cohort 1, Group 1: 2 Doses, Cohort 1, Group 2: 1 Dose, Cohort 1, Group 2: 2 Doses, Cohort 1, Group 2a: 1 Dose, Cohort 1, Group 2a: 2 Doses, Cohort 1, Group 3: 1 Dose, Cohort 1, Group 3: 2 Doses, Cohort 2, Group 4: 2 Doses, Cohort 2, Group 4: 3 Doses
GI.1/GII.4 (50/150)Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection	Biological	Cohort 1, Group 1: 1 Dose, Cohort 1, Group 1: 2 Doses, Cohort 1, Group 2: 1 Dose, Cohort 1, Group 2: 2 Doses, Cohort 1, Group 2a: 1 Dose, Cohort 1, Group 2a: 2 Doses, Cohort 1, Group 3: 1 Dose, Cohort 1, Group 3: 2 Doses, Cohort 2, Group 4: 2 Doses, Cohort 2, Group 4: 3 Doses
PlaceboPlacebo saline solution	Drug	Cohort 1, Group 1: 1 Dose, Cohort 1, Group 2: 1 Dose, Cohort 1, Group 2a: 1 Dose, Cohort 1, Group 3: 1 Dose, Cohort 2, Group 4: 2 Doses

Primary outcome

Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1
Time frame: Day 57
Seroresponse was defined as 4-fold rise or greater at Day 57 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).
Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 2
Time frame: Day 140
Seroresponse was defined as 4-fold rise or greater at Day 140 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).
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1
Time frame: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2
Time frame: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3
Time frame: Day 3 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4
Time frame: Day 4 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5
Time frame: Day 5 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6
Time frame: Day 6 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7
Time frame: Day 7 after either of the vaccination given on Days 1, 29, 56 or 112
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination
Time frame: Days 1 through 7 after each vaccination given on Days 1, 29, 56 or 112
Systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to <9 years; and irritability/fussiness, drowsiness, loss of appetite, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 6 weeks to <4 years on the day of vaccination and daily through Day 7 after each vaccination.
Body Temperature Through Day 7 Following Either Vaccination
Time frame: Post-vaccination approximately 30 minutes and 6 hours later, then daily through Day 7 after each vaccination given on Days 1, 29, 56 or 112
Body temperature measurement was performed using the thermometer provided by the site through Day 7 after each vaccination. The highest body temperature observed each day was recorded on the Diary Card. Body temperature is categorized as 1) Any (temperature 38°C or higher), 2) 38°C - <38.5°C, 3) 38.5°C - <39°C, 4) 39°C - <39.5°C, 5) 39.5°C - <40°C, 6) 40°C or higher. Number of participants with the particular body temperature is reported within the pre-defined categories.
Percentage of Participants With at Least One Unsolicited AE Following Either Vaccination Dose
Time frame: Unsolicited AEs were collected within 28 days of all vaccinations (Day 1 to 57 for Cohort 1 and Day 1 to 140 for Cohort 2)
Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293
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.

14 secondary outcomes

Percentage of Participants With a Seroresponse for GI.1 Virus-Like Particle (VLP) (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a Seroresponse for GII.4 Virus-Like Particle (VLP) (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
Time frame: Cohort 1: Day 57; Cohort 2: Day 140
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
Time frame: Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293

Results and safety

Results posted to the registry on 1 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1, Group 1: 1 Dose	61	57
Cohort 1, Group 1: 2 Doses	59	57
Cohort 1, Group 2: 1 Dose	61	58
Cohort 1, Group 2: 2 Doses	59	57
Cohort 1, Group 2a: 1 Dose	60	57
Cohort 1, Group 2a: 2 Doses	60	58
Cohort 1, Group 3: 1 Dose	60	52
Cohort 1, Group 3: 2 Doses	60	58
Cohort 2, Group 4: 2 Doses	180	165
Cohort 2, Group 4: 3 Doses	180	166

Primary outcome: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1

Time frame: Day 57. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1, Group 1: 1 Dose n = 53	Cohort 1, Group 1: 2 Doses n = 52	Cohort 1, Group 2: 1 Dose n = 51	Cohort 1, Group 2: 2 Doses n = 56	Cohort 1, Group 2a: 1 Dose n = 47	Cohort 1, Group 2a: 2 Doses n = 54	Cohort 1, Group 3: 1 Dose n = 49	Cohort 1, Group 3: 2 Doses n = 55
Value	77.4 (63.8 to 87.7)	63.5 (49.0 to 76.4)	74.5 (60.4 to 85.7)	85.7 (73.8 to 93.6)	53.2 (38.1 to 67.9)	70.4 (56.4 to 82.0)	71.4 (56.7 to 83.4)	92.7 (82.4 to 98.0)

Population analysed: Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.

Primary outcome: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 2

Time frame: Day 140. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 2, Group 4: 2 Doses n = 131	Cohort 2, Group 4: 3 Doses n = 146
Value	57.3 (48.3 to 65.9)	84.9 (78.1 to 90.3)

Primary outcome: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1

Time frame: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112. Number. Unit: percentage of participants

Measure	Cohort 1, Group 1: 1 Dose n = 61	Cohort 1, Group 1: 2 Doses n = 59	Cohort 1, Group 2: 1 Dose n = 61	Cohort 1, Group 2: 2 Doses n = 59	Cohort 1, Group 2a: 1 Dose n = 60	Cohort 1, Group 2a: 2 Doses n = 60	Cohort 1, Group 3: 1 Dose n = 60	Cohort 1, Group 3: 2 Doses n = 60	Cohort 2, Group 4: 2 Doses n = 180	Cohort 2, Group 4: 3 Doses n = 179
Any solicited local AEs	52.5	66.1	34.4	45.8	26.7	30.0	11.7	13.3	22.2	30.7
Pain	52.5	66.1	34.4	35.6	26.7	25.0	8.3	13.3	22.2	28.5
Erythema	0	1.7	1.6	0	0	1.7	3.3	0	1.1	2.8
Induration	1.6	1.7	0	1.7	0	1.7	1.7	0	0	0
Swelling	0	5.1	0	0	0	1.7	0	0	0.6	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.

Primary outcome: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2

Time frame: Day 1 after either of the vaccination given on Days 1, 29, 56 or 112. Number. Unit: percentage of participants

Measure	Cohort 1, Group 1: 1 Dose n = 60	Cohort 1, Group 1: 2 Doses n = 58	Cohort 1, Group 2: 1 Dose n = 61	Cohort 1, Group 2: 2 Doses n = 59	Cohort 1, Group 2a: 1 Dose n = 60	Cohort 1, Group 2a: 2 Doses n = 60	Cohort 1, Group 3: 1 Dose n = 58	Cohort 1, Group 3: 2 Doses n = 59	Cohort 2, Group 4: 2 Doses n = 176	Cohort 2, Group 4: 3 Doses n = 178
Any solicited local AEs	41.0	44.1	8.2	25.4	13.3	15.0	10.0	5.0	13.3	14.5
Pain	41.7	44.8	6.6	23.7	13.3	13.3	6.9	5.1	13.6	14.6
Erythema	0	0	3.3	5.1	0	0	1.7	0	0.6	0
Induration	0	0	0	1.7	0	1.7	0	0	0	0
Swelling	0	0	0	1.7	0	1.7	1.7	0	0.6	0

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) and AEs leading to trial withdrawal throughout the trial (Up to Day 210 for Cohort 1 and Day 293 for Cohort 2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1, Group 1: 1 Dose	1 of 61 (1.6%)	25 of 61 (41%)	0 of 61
Cohort 1, Group 1: 2 Doses	2 of 59 (3.4%)	27 of 59 (45.8%)	0 of 59
Cohort 1, Group 2: 1 Dose	1 of 61 (1.6%)	28 of 61 (45.9%)	0 of 61
Cohort 1, Group 2: 2 Doses	2 of 59 (3.4%)	32 of 59 (54.2%)	0 of 59
Cohort 1, Group 2a: 1 Dose	6 of 60 (10%)	21 of 60 (35%)	0 of 60
Cohort 1, Group 2a: 2 Doses	1 of 60 (1.7%)	19 of 60 (31.7%)	0 of 60
Cohort 1, Group 3: 1 Dose	6 of 60 (10%)	36 of 60 (60%)	0 of 60
Cohort 1, Group 3: 2 Doses	5 of 60 (8.3%)	35 of 60 (58.3%)	0 of 60
Cohort 2, Group 4: 2 Doses	17 of 180 (9.4%)	119 of 180 (66.1%)	0 of 180
Cohort 2, Group 4: 3 Doses	24 of 179 (13.4%)	122 of 179 (68.2%)	0 of 179

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37140558Lopez P, Lopez-Medina E, Saez-Llorens X, deAntonio R, Masuda T, Mendelman PM, Sherwood J, Baehner F, Borkowski A. Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2204787. doi: 10.1080/21645515.2023.2204787. Epub 2023 May 4.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GI.1/GII.4 (15/15), GI.1/GII.4 (15/50) and GI.1/GII.4 (50/50) in people with Norovirus, run by Takeda at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Finland, Panama, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1 (time frame: Day 57). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.