PoliomyelitisPhase 3NCT03821441
Trail To Evaluate the Immune Effects of Primary and Booster Immunizations With Poliovirus Vaccine
A Phase 3 study testing bOPV(Candy) and bOPV(Liquid) in people with Poliomyelitis, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Trail To Evaluate the Immunity Duration of healthy children who already took part in " The safety and immunogenicity by different sequential schedules of bOPV and bOPV in dragee candy with sIPV, a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month old in… Read more about this study
- Who is it for?
- Ages 24 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- bOPV(Candy) and bOPV(Liquid)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,165 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2018to Aug 2020
- 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 24 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who have already taken part in phase 3 clinical trail in Guangxi and were vaccinated 3-dose primary immunization with polio vaccines .Moreover，the results of the selected paired serum are required.
- 24 months old(calendar month).
- Guardians understand the contents and requirements of this trail , meanwhile, voluntarily joined this study with informed consents.
- Able to attend all scheduled visits and to comply with all trial procedures(including vaccinate and blood collection)
Who cannot join
- Any booster immunization with polio vaccine after finishing 3-dose primary immunizations research.
- Polio virus infection was demonstrated in laboratory experiment.
- Participation in another clinical trial at the same times.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives or increase the risk of subjects,such as acute or chronic diseases 、some abnormal detected by lab,and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi
Zhaojun Mo, Master
Zhaojun Mo, Master
About this study
Official title: Trail To Evaluate the Immunity Duration of Different Sequential Immunization Schedules and Effectiveness for Bivalent Oral Poliomyelitis Vaccine Co-administered With IPV Booster Immunization for Poliovirus Vaccine
Trail To Evaluate the Immunity Duration of healthy children who already took part in " The safety and immunogenicity by different sequential schedules of bOPV and bOPV in dragee candy with sIPV, a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month old in Guangxi Province, China" and continue to search for the effects of booster immunization.
Read the detailed description
According to the requirement of the Strategy of Polio Eradication \& Endgame Strategic Plan 2013-2018, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) need to be used to eradiation both the wild poliovirus and vaccine-derived poliovirus. To evaluate the safety and immunogenicity by different sequential immunization schedules of bOPV and bOPV in dragee candy with sIPV,a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Guangxi Province in China. A total of 1200 infants at 2 months old were selected, and randomlydivided into 12 different groups (100 individuals were included in each group) administrated the vaccines at 0, 28, 56 days schedule.The detail of each group as following:1)1-dose cIPV + 2-dose bOPV (Candy); 2)1-dose sIPV + 2-dose bOPV (Candy); 3)2-dose cIPV + 1-dose bOPV (Candy); 4)2-dose sIPV + 1-dose bOPV (Candy); 5)2-dose cIPV + 1-dose tOPV (Candy); 6)2-dose sIPV + 1-dose tOPV (Candy); 7)1-dose cIPV + 2-dose bOPV (Liquid); 8)1-dose sIPV + 2-dose bOPV (Liquid); 9)2-dose cIPV + 1-dose bOPV (Liquid); 10)2-dose sIPV + 1-dose bOPV (Liquid); 11)2-dose cIPV + 1-dose tOPV (Liquid); 12)2-dose sIPV + 1-dose tOPV (Liquid).Blood Sample was collected before vaccination and one month after the third dose of vaccination. Neutralization antibody against type I, Type I and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The fecal samples were collected to test viral shedding.The safety by different sequential schedule of the vaccines was also evaluated.This part of study have already been done in 2016.
To further evaluate the immunity duration of different sequential immunization schedules for bOPV and IPV ,more importantly,trying to research the effectiveness of bOPV booster immunization,the previous study will continue.
The detail of the research as following:
The subject, who have already receipted 3-dose polio vaccine for primary immunization in phase III clinical trail in Guangxi and with the result of the paired-serum, are recruited again.In order to research the immunity durability of primary immunizations of primary immunization(3 doses of immunization),blood samples are collected from the subject aged 24 months,36 months and 48 months separately.Neutralization antibody titers for against type I, Type I and Type III poliomyelitis virus are detected,moreover,the positive rate and antibody geometric mean titers are analyzed.
A single dose of bOPV（liquid/candy) will be given orally to subjects at the age of 48 months which can in support of the effectiveness research of booster immunization with bOPV. To protect the rights and interests of subjects,the investigator can use other poliovirus vaccine such as IPV instead when bOPV（liquid/candy）is not available.
The anticoagulant blood will be collected separatly at 48 months and the 28 days after booster immunization from subjects,which will be used to detect cellular immune response.
- Conditions
- Poliomyelitis
- Being tested
- bOPV(Candy), bOPV(Liquid)
- Keywords
- bOPV, IPV, Sequential immunization, Immunity Duration, Booster Immunization
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bOPV(Candy)Biological
A single dose of 1 pill orally of bOPV to subjects aged 48 months who recieved bOPV (candy) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization.
If bOPV(candy/liquid) is not available ,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV.
bOPV(Liquid)Biological
A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who recieved bOPV (liquid) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization.
If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV.
bOPV(Liquid)Biological
A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who received tOPV (liquid) produced by Beijing Tiantan Biological Products Co., Ltd. in primary immunization.
If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV.
| Study group | Role | What they receive |
|---|---|---|
| bOPV(Candy) | Experimental | bOPV (Candy): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 in Dragee Candy (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.
1g/pill,10 pills/pach,one pill each time; each pill containing polio virus≥5.92 lgCCID50 including type1 polio virus≥5.8 lgCCID50，type 3 polio virus ≥5.3lgCCID50. Receives: Biological: bOPV(Candy) |
| bOPV(Liquid) | Experimental | bOPV (Liquid): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.
0.5ml or 1.0ml each bottle;total content of polio virus≥7.12lgCCID50/ml，type1 polio virus≥7.0 lgCCID50/ml，type 3 polio virus ≥6.5lgCCID50/ml.(2 drops each person;be be equivalent to 0.1ml each person ) Receives: Biological: bOPV(Liquid) |
| bOPV（liquid） | Experimental | bOPV(Liquid):Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral Produced by Beijing Tiantan Biological Products Co., Ltd. 1.0ml each bottle,2 drops each person(be be equivalent to 0.1ml each person).(total content of polio virus≥6.12lgCCID50，type1 polio virus≥6.0 lgCCID50，type 3 polio virus ≥5.5lgCCID50 in each 0.1 ml) Receives: Biological: bOPV(Liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of anti-poliovirus antibodies.
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
Measured: at aged 24 months
Positive rate of anti-poliovirus antibodies.
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
Measured: at aged 36 months
Positive rate of anti-poliovirus antibodies.
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
Measured: at aged 48 months
Secondary outcomes (4)
The GMT and of positive rate anti-poliovirus antibodies in different age.
In order to know the duration of anti-poliovirus antibodies level.We will use the neutralization assay to research the duration of anti-poliovirus antibodies types1, 2, and 3 induced by bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with IPV.Using the method of neutralization assay. Defined ≥ 8 (1/dil) for anti-Poliovirus as positive.The data are used to analysis the GMT 、 positive rate of poliovirus antibodies.
Measured: at aged 24、36、48 months
The adverse reaction and event of polio vaccine occur in subjects
Local and systemic adverse events were active collected in subjects after boosting dose of bOPV.
Measured: following 28 days after the boosting dose of bOPV
The GMT 、seroconversion rate of poliovirus antibodies after booster immunization.
In order to know the rationality of booster immunization and make sure dose the subject need a booster immunization and when is the best time.The investigator will give one dose boosting vaccine（bOPV）when the subject aged 48 months.The type of bOPV (liquid/candy) depends on what kind of vaccine the child had eaten in" Randomized, Double Blind, Single Center, Parallel Trial to Evaluate the Safety and Immunogenicity by Different Sequential Immunization Schedules of Bivalent Oral Poliomyelitis Vaccine Co-administered With IPV in Infants Aged 2 Months." Using the method of neutralization assay to detect the poliovirus antibodies，defined ≥ 8 (1/dil) for anti-Poliovirus as positive.The data are used to analysis the GMT 、seroconversion rate of poliovirus antibodies.
Measured: at aged 48 months and 28 days after the boosting dose of bOPV
Cellular immunity situation in booster immunization
The anticoagulant blood will be collected separatly at 48 months and the 28 days after booster immunization from subjects,which will be used to detect cellular immune response. The blood were measured by flow cytometry,luminex or microarray,etc.
Measured: at aged 48 months and 28 days after the boosting dose of bOPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start4 Jan 2018
- Primary completionMay 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Jingsi Yang, Chinese Academy of Medical Sciences
- Investigators
- Zhaojun Mo, Master, Principal investigator, Guangxi Province Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821441
- Sponsor's protocol ID
- 201518502-C（bOPV-PRO-C）
- Status last verified
- May 2018
- First submitted
- 3 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trail To Evaluate the Immunity Duration of Different Sequential Immunization Schedules and Effectiveness for Bivalent Oral Poliomyelitis Vaccine Co-administered With IPV Booster Immunization for Poliovirus Vaccine
- ClinicalTrials.gov ID
- NCT03821441
- Acronym / sponsor ID
- 201518502-C（bOPV-PRO-C）
- Conditions
- Poliomyelitis
- Keywords
- bOPV, IPV, Sequential immunization, Immunity Duration, Booster Immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,165 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Jan 2019 (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.
Trail To Evaluate the Immunity Duration of healthy children who already took part in " The safety and immunogenicity by different sequential schedules of bOPV and bOPV in dragee candy with sIPV, a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month old in Guangxi Province, China" and continue to search for the effects of booster immunization.
Detailed description
According to the requirement of the Strategy of Polio Eradication \& Endgame Strategic Plan 2013-2018, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) need to be used to eradiation both the wild poliovirus and vaccine-derived poliovirus. To evaluate the safety and immunogenicity by different sequential immunization schedules of bOPV and bOPV in dragee candy with sIPV,a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Guangxi Province in China. A total of 1200 infants at 2 months old were selected, and randomlydivided into 12 different groups (100 individuals were included in each group) administrated the vaccines at 0, 28, 56 days schedule.The detail of each group as following:1)1-dose cIPV + 2-dose bOPV (Candy); 2)1-dose sIPV + 2-dose bOPV (Candy); 3)2-dose cIPV + 1-dose bOPV (Candy); 4)2-dose sIPV + 1-dose bOPV (Candy); 5)2-dose cIPV + 1-dose tOPV (Candy); 6)2-dose sIPV + 1-dose tOPV (Candy); 7)1-dose cIPV + 2-dose bOPV (Liquid); 8)1-dose sIPV + 2-dose bOPV (Liquid); 9)2-dose cIPV + 1-dose bOPV (Liquid); 10)2-dose sIPV + 1-dose bOPV (Liquid); 11)2-dose cIPV + 1-dose tOPV (Liquid); 12)2-dose sIPV + 1-dose tOPV (Liquid).Blood Sample was collected before vaccination and one month after the third dose of vaccination. Neutralization antibody against type I, Type I and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The fecal samples were collected to test viral shedding.The safety by different sequential schedule of the vaccines was also evaluated.This part of study have already been done in 2016.
To further evaluate the immunity duration of different sequential immunization schedules for bOPV and IPV ,more importantly,trying to research the effectiveness of bOPV booster immunization,the previous study will continue.
The detail of the research as following:
The subject, who have already receipted 3-dose polio vaccine for primary immunization in phase III clinical trail in Guangxi and with the result of the paired-serum, are recruited again.In order to research the immunity durability of primary immunizations of primary immunization(3 doses of immunization),blood samples are collected from the subject aged 24 months,36 months and 48 months separately.Neutralization antibody titers for against type I, Type I and Type III poliomyelitis virus are detected,moreover,the positive rate and antibody geometric mean titers are analyzed.
A single dose of bOPV（liquid/candy) will be given orally to subjects at the age of 48 months which can in support of the effectiveness research of booster immunization with bOPV. To protect the rights and interests of subjects,the investigator can use other poliovirus vaccine such as IPV instead when bOPV（liquid/candy）is not available.
The anticoagulant blood will be collected separatly at 48 months and the 28 days after booster immunization from subjects,which will be used to detect cellular immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bOPV(Candy) | Experimental | Biological: bOPV(Candy)bOPV (Candy): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 in Dragee Candy (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 1g/pill,10 pills/pach,one pill each time; each pill containing polio virus≥5.92 lgCCID50 including type1 polio virus≥5.8 lgCCID50，type 3 polio virus ≥5.3lgCCID50. |
| bOPV(Liquid) | Experimental | Biological: bOPV(Liquid)bOPV (Liquid): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 0.5ml or 1.0ml each bottle;total content of polio virus≥7.12lgCCID50/ml，type1 polio virus≥7.0 lgCCID50/ml，type 3 polio virus ≥6.5lgCCID50/ml.(2 drops each person;be be equivalent to 0.1ml each person ) |
| bOPV（liquid） | Experimental | Biological: bOPV(Liquid)bOPV(Liquid):Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral Produced by Beijing Tiantan Biological Products Co., Ltd. 1.0ml each bottle,2 drops each person(be be equivalent to 0.1ml each person).(total content of polio virus≥6.12lgCCID50，type1 polio virus≥6.0 lgCCID50，type 3 polio virus ≥5.5lgCCID50 in each 0.1 ml) |
Who may qualify
- Ages
- 24 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects who have already taken part in phase 3 clinical trail in Guangxi and were vaccinated 3-dose primary immunization with polio vaccines .Moreover，the results of the selected paired serum are required.
- 24 months old(calendar month).
- Guardians understand the contents and requirements of this trail , meanwhile, voluntarily joined this study with informed consents.
- Able to attend all scheduled visits and to comply with all trial procedures(including vaccinate and blood collection)
Key exclusion criteria (4 listed)
- Any booster immunization with polio vaccine after finishing 3-dose primary immunizations research.
- Polio virus infection was demonstrated in laboratory experiment.
- Participation in another clinical trial at the same times.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives or increase the risk of subjects,such as acute or chronic diseases 、some abnormal detected by lab,and so on.
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 |
|---|---|---|
| bOPV(Candy)A single dose of 1 pill orally of bOPV to subjects aged 48 months who recieved bOPV (candy) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization. If bOPV(candy/liquid) is not available ,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV. | Biological | bOPV(Candy) |
| bOPV(Liquid)A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who recieved bOPV (liquid) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization. If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV. | Biological | bOPV(Liquid) |
| bOPV(Liquid)A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who received tOPV (liquid) produced by Beijing Tiantan Biological Products Co., Ltd. in primary immunization. If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV. | Biological | bOPV（liquid） |
Primary outcome
Positive rate of anti-poliovirus antibodies.
Time frame: at aged 24 months
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
Positive rate of anti-poliovirus antibodies.
Time frame: at aged 36 months
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
Positive rate of anti-poliovirus antibodies.
Time frame: at aged 48 months
To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.
4 secondary outcomes
The GMT and of positive rate anti-poliovirus antibodies in different age.
Time frame: at aged 24、36、48 months
The adverse reaction and event of polio vaccine occur in subjects
Time frame: following 28 days after the boosting dose of bOPV
The GMT 、seroconversion rate of poliovirus antibodies after booster immunization.
Time frame: at aged 48 months and 28 days after the boosting dose of bOPV
Cellular immunity situation in booster immunization
Time frame: at aged 48 months and 28 days after the boosting dose of bOPV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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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.
Zhaojun Mo, Master principal investigator
Guangxi Province Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bOPV(Candy) and bOPV(Liquid) in people with Poliomyelitis, run by Chinese Academy of Medical Sciences 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 4 inclusion and 4 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 29 Jan 2019. 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 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?
Contact Jingsi Yang, Master (+8687168334986, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of anti-poliovirus antibodies. (time frame: at aged 24 months). The study lists 3 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 29 Jan 2019.