GastroenteritisEarly Phase 1NCT05805618
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects
A Early Phase 1 study testing Recombinant Norovirus Hexavalent Vaccine in people with Gastroenteritis, run by Syneos Health.
Trial summary
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Recombinant Norovirus Hexavalent Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-59 years (inclusive);
- Subjects with a body mass index ( 18 kg/m2 and 35 kg/m2;
- Capable and willing to give informed consent prior to any study-specific activities/procedures;
- Subjects who are able to comply with the requirements of the clinical study protocol to complete the study;
- Subjects who haven't been vaccinated or haven't plan to be vaccinated with other vaccines (including live attenuated vaccines, non-live vaccines, and novel coronavirus vaccines) within 14 days before the first dose of study vaccines;
- Subjects who are clinically determined to be healthy by the investigator after being inquired about their medical history and relevant physical examinations;
- Female subjects who are not breastfeeding; all subjects who have no childbearing plan or sperm/egg donation plan from ICF signing to 6 months after the completion of the vaccination series and agree to take effective contraceptive measures (See the appendix 3) from 4 weeks prior to the first dose to 6 months after the completion of the vaccination series.
Who cannot join
- Subjects with positive COVID-19 test by PCR for nasopharyngeal or oropharyngeal swabs (nasopharyngeal swabs are preferred) on the day of the first dose vaccination;
- Subjects who have previously participated in a clinical study of any type of norovirus vaccines within the past year before enrollment in this study;
- Subjects with a history of chronic gastrointestinal disorder or having gastroenteritis that required treatment (for example, seek medical advice, etc.) within the past year before screening; or subjects have diarrhea, vomiting, or other digestive system conditions before 2 weeks of the first dose vaccination;
- Subjects have cancer or have a history of cancer within 5 years before screening;
- Subjects with the following conditions: (1) serious congenital malformations, serious developmental disorders, serious genetic defects, serious malnutritions, etc.; (2) thrombocytopenia, coagulation disorder or receipt of anticoagulant therapy, and other contraindications to intramuscular injections; (3) congenital or acquired immunodeficiency or receipt of immunosuppressant therapy (excluding topical treatment, surface treatment for acute non-complicated dermatitis, spray treatment for allergic rhinitis, ICS use for asthma treatmen, etc.) within 6 months; (4) history of infectious diseases, such as tuberculosis; (5) history or family history of convulsions, epilepsy, encephalopathy; (6) asplenia, functional asplenia, and asplenia or splenectomy due to any cause; (7) serious cardiovascular diseases (pulmonary heart disease and pulmonary edema), serious liver and kidney diseases, type I diabetes, celiac disease, autoimmune diseases, etc.; (8) use of medications within the timeframes specified in Section 6.5.2 ;
- Subjects with a clinicallly significant history of serious hypersensitivity to any component of study vaccines, including adjuvant components and yeast, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrotic reaction (Arthus reaction); a history of serious adverse vaccine or drug reactions, such as allergy, urticaria, skin eczema(small, local rashes on a single body part are permitted), dyspnea, and angioedema;
Show all 21Show fewer
- Subjects with abnormal and clinically significant results of laboratory tests at the discretion of Investigator, such as hematology, serum chemistry, and urinalysis;
- Subjects with abnormal and clinically significant ECG results up to the Investigator's discretion at screening;
- Females of childbearing potential with positive serum pregnancy test results;
- Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or anti-treponema pallidum (anti-TP) antibody at screening;
- Subjects with hypertension (systolic blood pressure 140 mmHg and/or diastolic blood pressure 90 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure 40 mmHg) (regardless of medication use) in the physical examination before enrollment;
- Subjects with fever (oral temperature ≥ 37.5 °C) on the day of vaccination with study vaccines or within 72 h before vaccination;
- Subjects who have donated blood or lost blood (≥ 400 mL) or received blood transfusion or used blood products within 30 days before signing the ICF or plan to donate blood during the study(from the first vaccination dose to 3 months after the completion of the vaccination series);
- Subjects who have undergone surgery within 3 months before signing the ICF or plan to undergo surgery (including cosmetic surgery, dental surgery, and oral surgery(excluding tooth filling, protaper and tooth extraction)) during the study (from the first vaccination dose to 3 months after the completion of the vaccination series);
- Smoking more than 10 cigarettes per week within 3 months prior to screening;
- History of alcohol abuse within 1 year prior to screening, or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%);
- History of drug abuse within 1 year prior to screening, or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, codeine and amphetamine derivatives) within 1 month prior to screening;
- Subjects with positive tests for drugs of abuse (including Amphetamines (AMP), Methamphetamines (MET), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Opiates (OPI), Methyl enedioxy methamphetamine (MDMA) , Phencyclidine (PCP), Tetrahydrocannabinol (THC)) and alcohol breath test;
- Subjects with tattoos, scars or skin defects covering the deltoid muscle who are not suitable to participate in the study up to the investigator's discretion;
- Subjects who cannot tolerate venipuncture or have a history of fear of needles or hemophobia;
- Subjects who are not suitable to participate in the study as determined by the investigator .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects Aged 18-59 Years
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.
Read the detailed description
It is planned to enroll healthy subjects and adopt a 3-dose vaccination schedule (day 0 to day 56) of intramuscular injections of study vaccines in the deltoid muscle of the upper arm of subjects on day 0, day 28 and day 56, respectively. The subjects will sequentially enter into the low and high dose groups by stages, with approximately 30 subjects in each group (test group:control group = 2:1) and approximately up to 60 subjects in total. At least half of the subjects are Chinese in the two cohorts respectively
- Conditions
- Gastroenteritis
- Being tested
- Recombinant Norovirus Hexavalent Vaccine, Matching Placebo
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Norovirus Hexavalent VaccineBiological
Also called KH002
To prevent acute gastroenteritis caused by norovirus of genotypes GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17
Matching PlaceboOther
matching placebo for Recombinant Norovirus Hexavalent Vaccine / KH002
| Study group | Role | What they receive |
|---|---|---|
| KH002 | Experimental | at low dose,150 mg(Cohort 1 ), 20 subjects are dosed Vaccine as experimental at high dose,300mg (Cohort 2), 20 subjects are dosed Vaccine as experimental Receives: Biological: Recombinant Norovirus Hexavalent Vaccine |
| matching placebo | Placebo comparator | at low dose,150 mg(Cohort 1 ), 10 subjects are dosed placebo at high dose, 300mg(Cohort 2),10 subjects are dosed placebo Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited AEs within 7 days after each vaccination dose.
Safety will be assessed through 7 days after vaccination (including the day of vaccination) via collection of solicited AEs. The solicited AEs include local AEs (injection site: pain,tenderness， induration,swelling,erythema,pruritus)and systemic AEs (Headache, Fatigue,Myalgia,Arthralgia,Vomiting, Diarrhea, Fever).
Measured: 7 Days
Incidence of unsolicited AEs within 28 days after each vaccination dose
Unsolicited AEs are AEs other than those designated as solicited AEs, and also include eponymous solicited AEs that occur after the solicitation period. Unsolicited AEs mainly include any AEs that have been reported by the subjects, learned from interrogation or observed by the investigator during the study visits, or discovered during review of medical records or original files. the incidence of unsolicited AEs within 28 days after each dose of the study vaccine will be calculated.
Measured: 28 Days
Incidence of AEs related to serum chemistry, hematology, and urinalysis parameters in all subjects on day 4 after each vaccination dose and on day 14, day 42 after the first dose
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry,hematology or urinalysis) collected.
Measured: 42 days
SAE, MAAE in all subjects within 12 months after the completion of the vaccination series.
The subjects will also be monitored for SAEs, MAAEs from the first dose to 12 months after the completion of the vaccination series.
Measured: 12 Months
Secondary outcomes (13)
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA (BT50)
GMT is geometric mean titer. HBGA is Histo-blood group antigen. Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination (up to Day 421)
Measured: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA
GMFR is geometric mean fold rise. Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination (up to Day 421)
Measured: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA
SCR is Seroconversion rate. Seroconversion is defined as: For the subject whose antibody titer is below the lower limit of quantification before vaccination, the antibody titer is increased to the lower limit of quantification or above after vaccination; for the subject whose antibody titer is at the lower limit of quantification or above before vaccination, the antibody titer is increased at least 4-fold after vaccination. Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination
Measured: 12 Months
Norovirus-specific T-cell IFN-γ,IL-2, IL-4 and IL-10 levels In the high dose group.
Predose 0 and 7, 28 days after completion of full vaccination
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jul 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Kanghua Biological Products Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, Dr, Principal investigator, Q-Pharm Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805618
- Sponsor's protocol ID
- KH-CT-002-01
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects Aged 18-59 Years
- ClinicalTrials.gov ID
- NCT05805618
- Acronym / sponsor ID
- KH-CT-002-01
- Conditions
- Gastroenteritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Chengdu Kanghua Biological Products Co., Ltd
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.
Detailed description
It is planned to enroll healthy subjects and adopt a 3-dose vaccination schedule (day 0 to day 56) of intramuscular injections of study vaccines in the deltoid muscle of the upper arm of subjects on day 0, day 28 and day 56, respectively. The subjects will sequentially enter into the low and high dose groups by stages, with approximately 30 subjects in each group (test group:control group = 2:1) and approximately up to 60 subjects in total. At least half of the subjects are Chinese in the two cohorts respectively
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| KH002 | Experimental | Biological: Recombinant Norovirus Hexavalent Vaccineat low dose,150 mg(Cohort 1 ), 20 subjects are dosed Vaccine as experimental at high dose,300mg (Cohort 2), 20 subjects are dosed Vaccine as experimental |
| matching placebo | Placebo comparator | Other: Matching Placeboat low dose,150 mg(Cohort 1 ), 10 subjects are dosed placebo at high dose, 300mg(Cohort 2),10 subjects are dosed placebo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-59 years (inclusive);
- Subjects with a body mass index ( 18 kg/m2 and 35 kg/m2;
- Capable and willing to give informed consent prior to any study-specific activities/procedures;
- Subjects who are able to comply with the requirements of the clinical study protocol to complete the study;
- Subjects who haven't been vaccinated or haven't plan to be vaccinated with other vaccines (including live attenuated vaccines, non-live vaccines, and novel coronavirus vaccines) within 14 days before the first dose of study vaccines;
Key exclusion criteria (21 listed)
- Subjects with positive COVID-19 test by PCR for nasopharyngeal or oropharyngeal swabs (nasopharyngeal swabs are preferred) on the day of the first dose vaccination;
- Subjects who have previously participated in a clinical study of any type of norovirus vaccines within the past year before enrollment in this study;
- Subjects with a history of chronic gastrointestinal disorder or having gastroenteritis that required treatment (for example, seek medical advice, etc.) within the past year before screening; or subjects have diarrhea, vomiting, or other digestive system conditions before 2 weeks of the first dose vaccination;
- Subjects have cancer or have a history of cancer within 5 years before screening;
- Subjects with the following conditions: (1) serious congenital malformations, serious developmental disorders, serious genetic defects, serious malnutritions, etc.; (2) thrombocytopenia, coagulation disorder or receipt of anticoagulant therapy, and other contraindications to intramuscular injections; (3) congenital or acquired immunodeficiency or receipt of immunosuppressant therapy (excluding topical treatment, surface treatment for acute non-complicated dermatitis, spray treatment for allergic rhinitis, ICS use for asthma treatmen, etc.) within 6 months; (4) history of infectious diseases, such as tuberculosis; (5) history or family history of convulsions, epilepsy, encephalopathy; (6) asplenia, functional asplenia, and asplenia or splenectomy due to any cause; (7) serious cardiovascular diseases (pulmonary heart disease and pulmonary edema), serious liver and kidney diseases, type I diabetes, celiac disease, autoimmune diseases, etc.; (8) use of medications within the timeframes specified in Section 6.5.2 ;
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 |
|---|---|---|
| Recombinant Norovirus Hexavalent VaccineAlso: KH002To prevent acute gastroenteritis caused by norovirus of genotypes GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17 | Biological | KH002 |
| Matching Placebomatching placebo for Recombinant Norovirus Hexavalent Vaccine / KH002 | Other | matching placebo |
Primary outcome
Incidence of solicited AEs within 7 days after each vaccination dose.
Time frame: 7 Days
Safety will be assessed through 7 days after vaccination (including the day of vaccination) via collection of solicited AEs. The solicited AEs include local AEs (injection site: pain,tenderness， induration,swelling,erythema,pruritus)and systemic AEs (Headache, Fatigue,Myalgia,Arthralgia,Vomiting, Diarrhea, Fever).
Incidence of unsolicited AEs within 28 days after each vaccination dose
Time frame: 28 Days
Unsolicited AEs are AEs other than those designated as solicited AEs, and also include eponymous solicited AEs that occur after the solicitation period. Unsolicited AEs mainly include any AEs that have been reported by the subjects, learned from interrogation or observed by the investigator during the study visits, or discovered during review of medical records or original files. the incidence of unsolicited AEs within 28 days after each dose of the study vaccine will be calculated.
Incidence of AEs related to serum chemistry, hematology, and urinalysis parameters in all subjects on day 4 after each vaccination dose and on day 14, day 42 after the first dose
Time frame: 42 days
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry,hematology or urinalysis) collected.
SAE, MAAE in all subjects within 12 months after the completion of the vaccination series.
Time frame: 12 Months
The subjects will also be monitored for SAEs, MAAEs from the first dose to 12 months after the completion of the vaccination series.
13 secondary outcomes
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA (BT50)
Time frame: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA
Time frame: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA
Time frame: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
Time frame: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
Time frame: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig
Time frame: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Time frame: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Time frame: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA
Time frame: 12 Months
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
Time frame: 12 Months
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
Time frame: 12 Months
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgG
Time frame: 12 Months
Norovirus-specific T-cell IFN-γ,IL-2, IL-4 and IL-10 levels In the high dose group.
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Gastroenteritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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.
Kristi McLendon, Dr principal investigator
Q-Pharm Pty Ltd
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Recombinant Norovirus Hexavalent Vaccine in people with Gastroenteritis, run by Syneos Health.
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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny Hou, PM (+86 18502191682, fanny.hou@syneoshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of solicited AEs within 7 days after each vaccination dose. (time frame: 7 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.