Rotavirus InfectionsPhase 2NCT05621655
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
A Phase 2 study testing Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine and High dose Recombinant Trivalent Subunit Rotavirus Vaccine in people with Rotavirus Infections and Rotavirus Gastroenteritis, run by MAXVAX Biotechnology Limited Liability Company at 2 sites in China.
Trial summary
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months. Read more about this study
- Who is it for?
- Ages 6 weeks to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections, Rotavirus Gastroenteritis
- What is being tested?
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine and High dose Recombinant Trivalent Subunit Rotavirus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,512 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jan 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months;
- Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).
Who cannot join
- First dose exclusion criteria:
- Axillary temperature >37.0℃ before vaccination;
- Recepit of any rotavirus vaccine in the past;
- History of intussusception or suffering from intussusception or history of any chronic gastrointestinal disease, including congenital malformations of the gastrointestinal tract that are likely to cause intussusception (such as Meckel's diverticulum);
- Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.;
- Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage;
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- Subjects aged 2 years or younger with history of premature birth (<37 weeks' gestation) or low birth weight (weight at birth of<2500 g);
- History of convulsions, epilepsy and cerebral palsy, or mental illness and family history;
- History of severe anaphylactic reaction to vaccination, or allergy to any components of the study vaccine;
- Acute diseases (such as fever>39.0℃) or acute exacerbation of chronic disease within 3 days before vaccination;
- Receipt of immune enhancement (including oral or intravenous immunoglobulin, but hepatitis B immunoglobulin is acceptable) or immunosuppressive therapy (continuous oral or intravenous infusion for more than 14 days) within 3 months;
- Recepit of live attenuated vaccines within 14 days, or other vaccines within 7 days;
- Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
- History of coagulation abnormalities (such as lack of blood coagulation factors, blood coagulopathy);
- Primary and secondary impairment of immune function (history of thyroid, pancreas, liver, spleen resection, or treatment due to thyroid disease within the past 12 months);
- Concurrent participation or plan to participate in another clinical trial throughout the study;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
- Subsequent vaccination exclusion criteria:
- Severe allergic reaction after the previous injection of study vaccine;
- Serious adverse reactions that are causally related to the previous vaccination;
- After the first vaccination, subjects with newly discovered or newly happened diseases that meet the first dose exclusion criteria will be determined by the investigator whether to continue participating the study;
- Other reasons for exclusion judged by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shangqiu Liangyuan District Center for Disease Control and Prevention
Shangqiu, Henan, 476000
Ningling County Center for Disease Control and Prevention
Shangqiu, Henan, 476700
About this study
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Subunit Rotavirus Vaccine in Healthy Infants Aged 6-12 Weeks and Healthy Toddlers Aged 7-71 Months
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
Read the detailed description
This clinical trial is aimed to evaluate the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in Chinese healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.The subjects will be divided into 12 subgroups. Two different immune regimens and two dose levels will be evaluated in each age group. Toddlers aged 7-71 months will receive two intramuscular injections on Day 0 and 28 or three intramuscular injections on Day 0, 28 and 56. Infants aged 6-12 weeks will receive three intramuscular injections on Day 0, 28 and 56 or Day 0, 56 and 112. Two dose (mid dose and high dose) will be included in each age group. To maintain blindness in the trial, in each age group with fixed immune regimen, subjects will be randomized in a 1:1:1 ratio to receive mid dose vaccine, high dose vaccine, or placebo.
- Conditions
- Rotavirus Infections, Rotavirus Gastroenteritis
- Being tested
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine, High dose Recombinant Trivalent Subunit Rotavirus Vaccine, Placebo
- Keywords
- Rotavirus, Gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid dose Recombinant Trivalent Subunit Rotavirus VaccineBiological
0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
High dose Recombinant Trivalent Subunit Rotavirus VaccineBiological
0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.
PlaceboBiological
0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Mid dose in toddlers (7-71 months old, 3 doses) | Experimental | Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| Mid dose in toddlers (7-71 months old, 2 doses) | Experimental | Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. Receives: Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| High dose in toddlers (7-71 months old, 3 doses) | Experimental | High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| High dose in toddlers (7-71 months old, 2 doses) | Experimental | High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. Receives: Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| Placebo in toddlers (7-71 months old, 3 doses) | Placebo comparator | Placebo in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: Placebo |
| Placebo in toddlers (7-71 months old, 2 doses) | Placebo comparator | Placebo in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. Receives: Biological: Placebo |
| Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Experimental | Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Experimental | Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. Receives: Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Experimental | High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Experimental | High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. Receives: Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine |
| Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Placebo comparator | Placebo in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. Receives: Biological: Placebo |
| Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Placebo comparator | Placebo in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
Incidence of adverse events within 30 minutes after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 30 minutes after each vaccination
The incidence of adverse events
Incidence of adverse events within 14 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 14 days after each vaccination
The incidence of adverse events
Incidence of adverse events Day 15 to 28/30 after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Day 15 to 28/30 after each vaccination
The incidence of adverse events
Incidence of adverse events within 28/30 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 28/30 days after each vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)
Measured by ELISA at baseline and 30 days after the last vaccination.
Measured: Day 30 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG)
Measured by ELISA at baseline and 30 days after the last vaccination.
Measured: Day 30 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test at baseline and 30 days after the last vaccination.
Measured: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Measured: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Measured: Day 30 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Measured: Day 30 after the last vaccination
Secondary outcomes (19)
Incidence of serious adverse events (SAE)
Incidence of serious adverse events throughout the study.
Measured: From the first vaccination to 12 months after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Measured: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Measured: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Measured by ELISA.
Measured: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Measured: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Measured: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Measured by ELISA.
Measured: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Measured: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Measured: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Neutralizing antibodies will be measured by Micro serum neutralization test.
Measured: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Measured: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Measured: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Measured: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Measured: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Measured: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Measured: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Measured: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Measured: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
Measured: Day 360 after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start8 Jan 2023
- Primary completion29 Apr 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,512 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621655
- Sponsor's protocol ID
- MKKCT2021002
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2022
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Subunit Rotavirus Vaccine in Healthy Infants Aged 6-12 Weeks and Healthy Toddlers Aged 7-71 Months
- ClinicalTrials.gov ID
- NCT05621655
- Acronym / sponsor ID
- MKKCT2021002
- Conditions
- Rotavirus Infections, Rotavirus Gastroenteritis
- Keywords
- Rotavirus, Gastroenteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,512 participants (actual)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Nov 2022 (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.
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
Detailed description
This clinical trial is aimed to evaluate the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in Chinese healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.The subjects will be divided into 12 subgroups. Two different immune regimens and two dose levels will be evaluated in each age group. Toddlers aged 7-71 months will receive two intramuscular injections on Day 0 and 28 or three intramuscular injections on Day 0, 28 and 56. Infants aged 6-12 weeks will receive three intramuscular injections on Day 0, 28 and 56 or Day 0, 56 and 112. Two dose (mid dose and high dose) will be included in each age group. To maintain blindness in the trial, in each age group with fixed immune regimen, subjects will be randomized in a 1:1:1 ratio to receive mid dose vaccine, high dose vaccine, or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Mid dose in toddlers (7-71 months old, 3 doses) | Experimental | Biological: Mid dose Recombinant Trivalent Subunit Rotavirus VaccineMid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. |
| Mid dose in toddlers (7-71 months old, 2 doses) | Experimental | Biological: Mid dose Recombinant Trivalent Subunit Rotavirus VaccineMid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. |
| High dose in toddlers (7-71 months old, 3 doses) | Experimental | Biological: High dose Recombinant Trivalent Subunit Rotavirus VaccineHigh dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. |
| High dose in toddlers (7-71 months old, 2 doses) | Experimental | Biological: High dose Recombinant Trivalent Subunit Rotavirus VaccineHigh dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. |
| Placebo in toddlers (7-71 months old, 3 doses) | Placebo comparator | Biological: PlaceboPlacebo in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected. |
| Placebo in toddlers (7-71 months old, 2 doses) | Placebo comparator | Biological: PlaceboPlacebo in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected. |
| Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Experimental | Biological: Mid dose Recombinant Trivalent Subunit Rotavirus VaccineMid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. |
| Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Experimental | Biological: Mid dose Recombinant Trivalent Subunit Rotavirus VaccineMid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. |
| High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Experimental | Biological: High dose Recombinant Trivalent Subunit Rotavirus VaccineHigh dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. |
| High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Experimental | Biological: High dose Recombinant Trivalent Subunit Rotavirus VaccineHigh dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. |
| Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals) | Placebo comparator | Biological: PlaceboPlacebo in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected. |
| Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals) | Placebo comparator | Biological: PlaceboPlacebo in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected. |
Who may qualify
- Ages
- 6 weeks to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months;
- Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).
Key exclusion criteria (22 listed)
- Axillary temperature >37.0℃ before vaccination;
- Recepit of any rotavirus vaccine in the past;
- History of intussusception or suffering from intussusception or history of any chronic gastrointestinal disease, including congenital malformations of the gastrointestinal tract that are likely to cause intussusception (such as Meckel's diverticulum);
- Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.;
- Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage;
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 |
|---|---|---|
| Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide. | Biological | Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals), Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals), Mid dose in toddlers (7-71 months old, 2 doses), Mid dose in toddlers (7-71 months old, 3 doses) |
| High dose Recombinant Trivalent Subunit Rotavirus Vaccine0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide. | Biological | High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals), High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals), High dose in toddlers (7-71 months old, 2 doses), High dose in toddlers (7-71 months old, 3 doses) |
| Placebo0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant. | Biological | Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals), Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals), Placebo in toddlers (7-71 months old, 2 doses), Placebo in toddlers (7-71 months old, 3 doses) |
Primary outcome
The incidence of adverse events
Time frame: Within 30 minutes after each vaccination
Incidence of adverse events within 30 minutes after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence of adverse events
Time frame: Within 14 days after each vaccination
Incidence of adverse events within 14 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence of adverse events
Time frame: Day 15 to 28/30 after each vaccination
Incidence of adverse events Day 15 to 28/30 after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence of adverse events
Time frame: Within 28/30 days after each vaccination
Incidence of adverse events within 28/30 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)
Time frame: Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG)
Time frame: Day 30 after the last vaccination
Measured by ELISA at baseline and 30 days after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 30 after the last vaccination
Neutralizing antibodies will be measured by Micro serum neutralization test at baseline and 30 days after the last vaccination.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 30 after the last vaccination
Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 30 after the last vaccination
Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 30 after the last vaccination
Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.
19 secondary outcomes
Incidence of serious adverse events (SAE)
Time frame: From the first vaccination to 12 months after the last vaccination.
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 360 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 90 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 180 after the last vaccination
Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
Time frame: Day 360 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 90 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 180 after the last vaccination
Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
Time frame: Day 360 after the last vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine and High dose Recombinant Trivalent Subunit Rotavirus Vaccine in people with Rotavirus Infections and Rotavirus Gastroenteritis, run by MAXVAX Biotechnology Limited Liability Company at 2 sites in China.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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?
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?
This study is still under way. Results are not available in the source record yet.
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?
The incidence of adverse events (time frame: Within 30 minutes after each vaccination). The study lists 10 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 20 Nov 2024.