PoliomyelitisPhase 3TTbOPVNCT02785705
Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine
A Phase 3 study testing poliovirus vaccine in people with Poliomyelitis, run by Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control.
Trial summary
Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. Read more about this study
- Who is it for?
- Ages 60 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- poliovirus vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2015
- 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 60 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.
Who cannot join
- Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.
About this study
Official title: Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine by Comparing Different Poliomyelitis Vaccination Schedules in Chinese Infant: a Randomized Controlled Non-Inferiority Clinical Trial
Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
Read the detailed description
A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.
- Conditions
- Poliomyelitis
- Being tested
- poliovirus vaccine
- Keywords
- immunization, vaccine schedule, poliomyelitis, polio, oral polio vaccine, inactivated polio vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poliovirus vaccineBiological
Also called bivalent types 1 and 3 oral poliovirus vaccine, trivalent conventional inactivated poliovirus vaccine, trivalent types 1, 2 and 3 oral poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
| Study group | Role | What they receive |
|---|---|---|
| cIPV-bOPV-bOPV poliovirus vaccine | Experimental | Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially. Receives: Biological: poliovirus vaccine |
| cIPV-tOPV-tOPV poliovirus vaccine | Experimental | Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially. Receives: Biological: poliovirus vaccine |
| cIPV-cIPV-bOPV poliovirus vaccine | Experimental | Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially. Receives: Biological: poliovirus vaccine |
| cIPV-cIPV-tOPV poliovirus vaccine | Experimental | Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially. Receives: Biological: poliovirus vaccine |
| cIPV-cIPV-cIPV poliovirus vaccine | Experimental | Participants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine. Receives: Biological: poliovirus vaccine |
| tOPV-tOPV-tOPV poliovirus vaccine | Experimental | Participants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine . Receives: Biological: poliovirus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants with seroconversion
Primary immunogenicity outcome was the proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants and the post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. Otherwise, the subjects are categories as unsusceptible ones.
Measured: 30 days after vaccination
Secondary outcomes (5)
Overall seroprotection rate
Overall seroprotection rate was defined as the proportion of subjects with reciprocal titre of at least eight.
Measured: 30 days after vaccination
Geometric mean of antibody titres (GMT)
Measured: 30 days after vaccination
Increase of geometric mean of antibody titres (GMI)
Measured: 30 days after vaccination
Proportion of infants with serious adverse events
Measured: Six months after vaccination
Solicited adverse events
Solicited adverse events involving both systemic reactions (including fever, irritability/fussiness, somnolence, vomit, diarrhea, and allergic reaction) and local reactions (including tenderness, redness, swelling, and callous around the injection sites).
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Sponsor type
- Other government
- Collaborators
- Air Force Military Medical University, China, Beijing Tiantan Biological Products Co., Ltd.
- Responsible party
- Principal investigator, Zhaojun Mo, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Investigators
- Zhaojun Mo, Principal investigator, Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785705
- Sponsor's protocol ID
- Tiantan-201417903
- Acronym
- TTbOPV
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine by Comparing Different Poliomyelitis Vaccination Schedules in Chinese Infant: a Randomized Controlled Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT02785705
- Acronym / sponsor ID
- TTbOPV / Tiantan-201417903
- Conditions
- Poliomyelitis
- Keywords
- immunization, vaccine schedule, poliomyelitis, polio, oral polio vaccine, inactivated polio vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlOther government
- Collaborators
- Air Force Military Medical University, China, Beijing Tiantan Biological Products Co., Ltd.
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 May 2016 (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.
Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
Detailed description
A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| cIPV-bOPV-bOPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially. |
| cIPV-tOPV-tOPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially. |
| cIPV-cIPV-bOPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially. |
| cIPV-cIPV-tOPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially. |
| cIPV-cIPV-cIPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine. |
| tOPV-tOPV-tOPV poliovirus vaccine | Experimental | Biological: poliovirus vaccineParticipants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine . |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.
Key exclusion criteria (1 listed)
- Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.
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 |
|---|---|---|
| poliovirus vaccineAlso: bivalent types 1 and 3 oral poliovirus vaccine, trivalent conventional inactivated poliovirus vaccine, trivalent types 1, 2 and 3 oral poliovirus vaccineDifferent vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively. | Biological | cIPV-bOPV-bOPV poliovirus vaccine, cIPV-cIPV-bOPV poliovirus vaccine, cIPV-cIPV-cIPV poliovirus vaccine, cIPV-cIPV-tOPV poliovirus vaccine, cIPV-tOPV-tOPV poliovirus vaccine, tOPV-tOPV-tOPV poliovirus vaccine |
Primary outcome
Proportion of infants with seroconversion
Time frame: 30 days after vaccination
Primary immunogenicity outcome was the proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants and the post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. Otherwise, the subjects are categories as unsusceptible ones.
5 secondary outcomes
Overall seroprotection rate
Time frame: 30 days after vaccination
Geometric mean of antibody titres (GMT)
Time frame: 30 days after vaccination
Increase of geometric mean of antibody titres (GMI)
Time frame: 30 days after vaccination
Proportion of infants with serious adverse events
Time frame: Six months after vaccination
Solicited adverse events
Time frame: 30 days after vaccination
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 30 May 2016.
- Individual participant dataSharing planned: No
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Poliomyelitis
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 principal investigator
Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing poliovirus vaccine in people with Poliomyelitis, run by Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control.
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 1 inclusion and 1 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 30 May 2016. 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. 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?
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?
Proportion of infants with seroconversion (time frame: 30 days 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 30 May 2016.