RotavirusPhase 4NCT02153866
The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
A Phase 4 study testing rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine in people with Rotavirus, run by Sichuan Center for Disease Control and Prevention.
Trial summary
Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study. Read more about this study
- Who is it for?
- Ages 8 to 9 months
- Conditions the study is for
- Rotavirus
- What is being tested?
- rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,800 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2014
- 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 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8~9 months healthy child
- Subjects or guardians who can and will comply with the requirements of the protocol
- Without vaccination history of rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine.
- Axillary temperature is under 37.0℃.
- Accord with the requirement of drug manual of rotavirus vaccine,measles-rubella vaccine and measles-mumps-rubella vaccine.
Who cannot join
- Allergic to any component of the vaccines.
- Women of pregnancy, lactation or about to be pregnant in 60 days.
- Infected by some rash disease within one month.
- Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
- Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 4 weeks.
- Family history of seizures or progressive neurological disease.
- Diarrheal caused by rotavirus or lasting for 3 or more days.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
About this study
Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study.
The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.
Read the detailed description
- Quality control plan:
- All vaccinators should get professional training held by local Health Bureau, and be qualified by local Health Bureau.
- All the clinical trial related staffs are trained by provincial or prefectural Center for Disease Control and prevention (CDC) at the beginning.
- Provincial and prefectural CDCs conduct supervision at each step, especially during field vaccination and Adverse Events Following Immunization (AEFI) investigation.
- Data valid check is designed to work in the database inputting, double entry and validation is also required.
- The field works are conduct under SOP (Standard Operating Procedures), The SOP for vaccination procedures which include vaccinee recruitment and vaccination practice etc. is 'Immunization Work Specification' issued by China Ministry of Health in 2005. The SOP for AEFI surveillance is 'AEFI surveillance guideline' issued by China Ministry of Health in 2010.
- Statistical plan
- Safety evaluation The analytic data include all reactions or events within 30 days after vaccination, compare the incidence of reactions among different vaccines, the statistical method is chi-square.
- Immunogenicity evaluation Compare the antibody positive rate and Geometric Mean Concentration between pre-vaccination and post-vaccination, and among different vaccine combinations.
- safety evaluation method At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, >38.5°C), angioedema, or a local injection-site reaction (diameter, >2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.
- Immunogenicity evaluation
Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.
- Conditions
- Rotavirus
- Being tested
- rotavirus vaccine, measles-rubella vaccine, measles-mumps-rubella vaccine
- Keywords
- rotavirus vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotavirus vaccineBiological
3ml/dose, oral
measles-rubella vaccineBiological
Also called measles-rubella live attenuated vaccine
0.5ml per dose, subcutaneous injection
measles-mumps-rubella vaccineBiological
Also called measles-mumps-rubella live attenuated vaccine
0.5ml per dose, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| rotavirus | Placebo comparator | vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months Receives: Biological: rotavirus vaccine |
| measles-rubella | Placebo comparator | vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months. Receives: Biological: measles-rubella vaccine |
| measles-mumps-rubella | Placebo comparator | vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months. Receives: Biological: measles-mumps-rubella vaccine |
| rotavirus, measles-rubella | Experimental | simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8~9 months. Receives: Biological: rotavirus vaccine; Biological: measles-rubella vaccine |
| rotavirus, measles-mumps-rubella | Experimental | simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8~9 months. Receives: Biological: rotavirus vaccine; Biological: measles-mumps-rubella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence rate of general reaction of different vaccination groups
general reaction includes fever (axillary temperature> 3.85℃), local injection-site reaction (diameter> 2.5 cm) etc.
Measured: 1 months after vaccination
Secondary outcomes (2)
the occurrence rate of severe adverse event of different vaccination groups
severe reaction include: anaphylaxis, angioedema, purpura, an Arthus reaction, febrile convulsion, seizure, polyneuritis, other adverse events cause fatal, result in disability or clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine)
Measured: 1 month after vaccination
The variation of antibody Geometric Mean Titer compared between before and after vaccination
this measure is used to assess the immunogenicity of different groups
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RotavirusStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Sponsor
- Investigators
- rui ao, Master, Study director, Sichuan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153866
- Sponsor's protocol ID
- cnbg-001
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
- ClinicalTrials.gov ID
- NCT02153866
- Acronym / sponsor ID
- cnbg-001
- Conditions
- Rotavirus
- Keywords
- rotavirus vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Sichuan Center for Disease Control and PreventionOther government
- Collaborators
- China National Biotec Group Company Limited
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- 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.
Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study.
The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.
Detailed description
- Quality control plan:
- All vaccinators should get professional training held by local Health Bureau, and be qualified by local Health Bureau.
- All the clinical trial related staffs are trained by provincial or prefectural Center for Disease Control and prevention (CDC) at the beginning.
- Provincial and prefectural CDCs conduct supervision at each step, especially during field vaccination and Adverse Events Following Immunization (AEFI) investigation.
- Data valid check is designed to work in the database inputting, double entry and validation is also required.
- The field works are conduct under SOP (Standard Operating Procedures), The SOP for vaccination procedures which include vaccinee recruitment and vaccination practice etc. is 'Immunization Work Specification' issued by China Ministry of Health in 2005. The SOP for AEFI surveillance is 'AEFI surveillance guideline' issued by China Ministry of Health in 2010.
- Statistical plan
- Safety evaluation The analytic data include all reactions or events within 30 days after vaccination, compare the incidence of reactions among different vaccines, the statistical method is chi-square.
- Immunogenicity evaluation Compare the antibody positive rate and Geometric Mean Concentration between pre-vaccination and post-vaccination, and among different vaccine combinations.
- safety evaluation method At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, >38.5°C), angioedema, or a local injection-site reaction (diameter, >2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.
- Immunogenicity evaluation
Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| rotavirus | Placebo comparator | Biological: rotavirus vaccinevaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months |
| measles-rubella | Placebo comparator | Biological: measles-rubella vaccinevaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months. |
| measles-mumps-rubella | Placebo comparator | Biological: measles-mumps-rubella vaccinevaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months. |
| rotavirus, measles-rubella | Experimental | Biological: rotavirus vaccine, Biological: measles-rubella vaccinesimultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8~9 months. |
| rotavirus, measles-mumps-rubella | Experimental | Biological: rotavirus vaccine, Biological: measles-mumps-rubella vaccinesimultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8~9 months. |
Who may qualify
- Ages
- 8 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 8~9 months healthy child
- Subjects or guardians who can and will comply with the requirements of the protocol
- Without vaccination history of rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine.
- Axillary temperature is under 37.0℃.
- Accord with the requirement of drug manual of rotavirus vaccine,measles-rubella vaccine and measles-mumps-rubella vaccine.
Key exclusion criteria (8 listed)
- Allergic to any component of the vaccines.
- Women of pregnancy, lactation or about to be pregnant in 60 days.
- Infected by some rash disease within one month.
- Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
- Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 4 weeks.
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 |
|---|---|---|
| rotavirus vaccine3ml/dose, oral | Biological | rotavirus, rotavirus, measles-mumps-rubella, rotavirus, measles-rubella |
| measles-rubella vaccineAlso: measles-rubella live attenuated vaccine0.5ml per dose, subcutaneous injection | Biological | measles-rubella, rotavirus, measles-rubella |
| measles-mumps-rubella vaccineAlso: measles-mumps-rubella live attenuated vaccine0.5ml per dose, subcutaneous injection | Biological | measles-mumps-rubella, rotavirus, measles-mumps-rubella |
Primary outcome
the occurrence rate of general reaction of different vaccination groups
Time frame: 1 months after vaccination
general reaction includes fever (axillary temperature> 3.85℃), local injection-site reaction (diameter> 2.5 cm) etc.
2 secondary outcomes
the occurrence rate of severe adverse event of different vaccination groups
Time frame: 1 month after vaccination
The variation of antibody Geometric Mean Titer compared between before and after vaccination
Time frame: 1 month after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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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.
rui ao, Master study director
Sichuan Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine in people with Rotavirus, run by Sichuan Center for Disease Control and Prevention.
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 5 inclusion and 8 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 3 Jun 2014. 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?
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?
Results are not available in the source record.
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 occurrence rate of general reaction of different vaccination groups (time frame: 1 months after vaccination). 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 3 Jun 2014.