ImmunotoxicityPhase 4NCT05161845
Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live
A Phase 4 study testing Measles, Mumps and Rubella Combined Vaccine, Live in people with Immunotoxicity and Vaccine, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live. Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunotoxicity, Vaccine
- What is being tested?
- Measles, Mumps and Rubella Combined Vaccine, Live
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,068 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to 1 Oct 2022
- Phase
- Phase 4
- 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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
- Volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form；
- The volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
Who cannot join
- The axillary body temperature on the day of enrollment was more than 37.0 ℃;
- Have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella;
- Any previous vaccination containing measles, mumps and rubella;
- Persons known to be allergic to any ingredient in the investigational vaccine;
- Any previous history of vaccine or drug allergy;
- Premature (delivered before the 37th week of pregnancy) and low weight (birth weight < 2500g);
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- History of dystocia, asphyxia rescue and nervous system damage;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination;
- Have a history of live attenuated vaccine within 28 days before vaccination and other vaccines within 7 days;
- Those who receive immune enhancement or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days);
- Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- History of asthma, unstable in the past two years, requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids;
- Have received blood or blood related products;
- Patients with progressive nervous system diseases have a history of convulsion, epilepsy, encephalopathy, GuillainBarre syndrome, mental history or family history;
- Have a history of abnormal coagulation function (such as coagulation factor deficiency and coagulation diseases);
- Plan to move out before the end of the study or leave for a long time during the scheduled study visit;
- Participating in or planning to participate in other clinical trials in the near future;
- The investigator judges any situation that is not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu
About this study
Official title: A Phase IV Randomized, Blinded Clinical Trial to Assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) Lot-to-lot Consistency in Healthy Chinese Children at the Age of 8-12 Months
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Read the detailed description
To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
- Conditions
- Immunotoxicity, Vaccine
- Being tested
- Measles, Mumps and Rubella Combined Vaccine, Live
- Keywords
- MMR Combined Vaccines, safety, immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles, Mumps and Rubella Combined Vaccine, LiveBiological
0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0. Receives: Biological: Measles, Mumps and Rubella Combined Vaccine, Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean concentrations (GMC)
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
Measured: 42 days
Secondary outcomes (5)
The positive conversion rate of antibodies
- The positive conversion rate of antibodies to measles, mumps and rubella in each group 42 days after vaccination.The seroconversion rate refers to the proportion of subjects whose serum antibodies are negative before vaccination, which turn positive after vaccination, or serum antibodies are positive before vaccination, which increased by 4 times or more after vaccination.
Measured: 42 days
The Seropositivity rate
The seroprevalence rate refers to the proportion of subjects whose serum antibodies are positive. The cut-off for seropositivity for the antibody titers is as follows:
- Anti-measles IgG antibody concentration by ELISA of >200 mIU/mL.
- Anti-mumps IgG antibody concentration by ELISA of >100 U/mL.
- Anti-rubella IgG antibody concentration by ELISA of >20 IU/mL
Measured: 42 days
The incidence of adverse events within 14 days
The incidence of adverse events within 14 days after vaccination
Measured: 14 days
All adverse events
All adverse events from day 0 to 42 after vaccination
Measured: 42 days
Serious adverse events
Serious adverse events within 6 months after vaccination
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start23 Dec 2021
- Primary completion4 Apr 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotoxicityStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongxing Pan, Principal investigator, Jiangsu Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161845
- Sponsor's protocol ID
- SIBP-MMR-01
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 14 Aug 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomized, Blinded Clinical Trial to Assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) Lot-to-lot Consistency in Healthy Chinese Children at the Age of 8-12 Months
- ClinicalTrials.gov ID
- NCT05161845
- Acronym / sponsor ID
- SIBP-MMR-01
- Conditions
- Immunotoxicity, Vaccine
- Keywords
- MMR Combined Vaccines, safety, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 17 Dec 2021 (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 immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Detailed description
To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Measles, Mumps and Rubella Combined Vaccine, LiveParticipants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0. |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
- Volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form；
- The volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
Key exclusion criteria (19 listed)
- The axillary body temperature on the day of enrollment was more than 37.0 ℃;
- Have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella;
- Any previous vaccination containing measles, mumps and rubella;
- Persons known to be allergic to any ingredient in the investigational vaccine;
- Any previous history of vaccine or drug allergy;
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 |
|---|---|---|
| Measles, Mumps and Rubella Combined Vaccine, Live0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus. | Biological | Experimental group |
Primary outcome
The geometric mean concentrations (GMC)
Time frame: 42 days
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
5 secondary outcomes
The positive conversion rate of antibodies
Time frame: 42 days
The Seropositivity rate
Time frame: 42 days
The incidence of adverse events within 14 days
Time frame: 14 days
All adverse events
Time frame: 42 days
Serious adverse events
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- 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.
Hongxing Pan principal investigator
Jiangsu Provincial Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measles, Mumps and Rubella Combined Vaccine, Live in people with Immunotoxicity and Vaccine, run by Shanghai Institute Of Biological Products at 1 site 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 3 inclusion and 19 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 geometric mean concentrations (GMC) (time frame: 42 days). 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 14 Aug 2023.