RandomizedPhase 3NCT01738074
Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
A Phase 3 study testing trivalent rotavirus genetic reassortment vaccine in people with Randomized and Double-blind, run by Center for Disease Control and Prevention, Henan Province.
Trial summary
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine. Read more about this study
- Who is it for?
- Ages 6 to 13 weeksHealthy volunteers can take part
- Conditions the study is for
- Randomized, Double-blind, Placebo Control Design
- What is being tested?
- trivalent rotavirus genetic reassortment vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,020 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 3
- 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 6 to 13 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 13 weeks aged healthy baby;
- Guardian volunteer to participate in the study and sign informed consent;
- have use thermometer as required and the ability to fill in the diary table;
- Subjects guardian can abide by the requirements of clinical research scheme;
- The past has not been vaccinated rotavirus vaccine;
- Normal term eutocia, birth weight up to standard;
- Axillary temperature is 37.0 ℃ or less.
Who cannot join
- With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
- Be allergy to any ingredients in the vaccine;
- Known immunology function damage or low person;
- Immunosuppressant therapy Accepter;
- Suffering from congenital malformation and developmental disorder;
- Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
- Inoculation other vaccine within 7 days.
About this study
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
- Conditions
- Randomized, Double-blind, Placebo Control Design
- Being tested
- trivalent rotavirus genetic reassortment vaccine, Placebo
- Keywords
- rotavirus, trivalent genetic reassortment vaccine, Phase three clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent rotavirus genetic reassortment vaccineBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| trivalent rotavirus genetic reassortment vaccine | Experimental | 2ml of rotavirus genetic reassortment vaccine by mouth every month for three month Receives: Biological: trivalent rotavirus genetic reassortment vaccine |
| Placebo | Placebo comparator | 2ml of placebo by mouth every month for three month Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titer differences in serum
Measured: 4 weeks after full vaccination
Incidence differences of rotavirus diarrhea
Measured: 2 years after full vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RandomizedStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Disease Control and Prevention, Henan Province
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738074
- Sponsor's protocol ID
- HNCDC-001
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
- ClinicalTrials.gov ID
- NCT01738074
- Acronym / sponsor ID
- HNCDC-001
- Conditions
- Randomized, Double-blind, Placebo Control Design
- Keywords
- rotavirus, trivalent genetic reassortment vaccine, Phase three clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,020 participants (actual)
- Lead sponsor
- Center for Disease Control and Prevention, Henan ProvinceOther government
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 Nov 2012 (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.
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trivalent rotavirus genetic reassortment vaccine | Experimental | Biological: trivalent rotavirus genetic reassortment vaccine2ml of rotavirus genetic reassortment vaccine by mouth every month for three month |
| Placebo | Placebo comparator | Biological: Placebo2ml of placebo by mouth every month for three month |
Who may qualify
- Ages
- 6 to 13 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6 to 13 weeks aged healthy baby;
- Guardian volunteer to participate in the study and sign informed consent;
- have use thermometer as required and the ability to fill in the diary table;
- Subjects guardian can abide by the requirements of clinical research scheme;
- The past has not been vaccinated rotavirus vaccine;
Key exclusion criteria (7 listed)
- With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
- Be allergy to any ingredients in the vaccine;
- Known immunology function damage or low person;
- Immunosuppressant therapy Accepter;
- Suffering from congenital malformation and developmental disorder;
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 |
|---|---|---|
| trivalent rotavirus genetic reassortment vaccine | Biological | trivalent rotavirus genetic reassortment vaccine |
| Placebo | Biological | Placebo |
Primary outcome
Antibody titer differences in serum
Time frame: 4 weeks after full vaccination
Incidence differences of rotavirus diarrhea
Time frame: 2 years after full vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trivalent rotavirus genetic reassortment vaccine in people with Randomized and Double-blind, run by Center for Disease Control and Prevention, Henan Province.
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 7 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 30 Nov 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Antibody titer differences in serum (time frame: 4 weeks after full vaccination). The study lists 2 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 30 Nov 2012.