PoliomyelitisPhase 3IPVNCT01510366
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
A Phase 3 study testing Inactivated Poliomyelitis Vaccine (Sabin strains) and Inactivated Poliomyelitis Vaccine (Salk strains) in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV). 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?
- Inactivated Poliomyelitis Vaccine (Sabin strains) and Inactivated Poliomyelitis Vaccine (Salk strains)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2012to Sep 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
- Males and females, age from 60 days to 90 days;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
Who cannot join
- Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth;
- Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Show all 12Show fewer
- Have serious anaphylaxis or high fever, convulsion during first dose;
- Have any circus of Exclusion Criteria after Eligible for study;
- Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
- Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
- Vaccinated with any other vaccine（except DTP）;
- Stop observation determined by investigator owing to occurring serious adverse event.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Pingle Center for Disease Prevention and Control
Guilin, Guangxi, 530400
Bingyang Center for Disease Prevention and Control
Nanning, Guangxi, 530400
About this study
Official title: The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Read the detailed description
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.
Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.
This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
- Conditions
- Poliomyelitis
- Being tested
- Inactivated Poliomyelitis Vaccine (Sabin strains), Inactivated Poliomyelitis Vaccine (Salk strains)
- Keywords
- Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Poliomyelitis Vaccine (Sabin strains)Biological
Also called Sabin IPV
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Inactivated Poliomyelitis Vaccine (Salk strains)Biological
Also called Salk IPV or cIPV
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections. Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) |
| Cohort 2: | Experimental | Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections. Receives: Biological: Inactivated Poliomyelitis Vaccine (Salk strains) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
Measured: fours year
Secondary outcomes (2)
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination
Measured: One year
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses.
Measured: 30-60 days after third dose immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, China
- Responsible party
- Sponsor
- Investigators
- Guoyang Liao, PH.D, Principal investigator, Institute of Medical Biology, Chinese Academy of Medical SciencesYanping Li, MD, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlChanggui Li, PHD, Principal investigator, National Institute for the Control of Pharmaceutical and Biological Products, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510366
- Sponsor's protocol ID
- IMBCAMS-03
- Other IDs
- 2011L01484
- Acronym
- IPV
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2012
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.
PubMed 37745024
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
- ClinicalTrials.gov ID
- NCT01510366
- Acronym / sponsor ID
- IPV / IMBCAMS-03
- Conditions
- Poliomyelitis
- Keywords
- Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, China
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jan 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.
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Detailed description
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.
Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.
This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections. |
| Cohort 2: | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Salk strains)Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections. |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males and females, age from 60 days to 90 days;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
Key exclusion criteria (12 listed)
- Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth;
- Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
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 |
|---|---|---|
| Inactivated Poliomyelitis Vaccine (Sabin strains)Also: Sabin IPVInactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart. | Biological | Cohort 1 |
| Inactivated Poliomyelitis Vaccine (Salk strains)Also: Salk IPV or cIPVInactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart. | Biological | Cohort 2: |
Primary outcome
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time frame: fours year
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
2 secondary outcomes
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Time frame: One year
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
Time frame: 30-60 days after third dose immunization
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 11 Oct 2023.
- Derived from this study: PubMed 37745024Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.
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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.
Guoyang Liao, PH.D principal investigator
Institute of Medical Biology, Chinese Academy of Medical Sciences
Yanping Li, MD principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Changgui Li, PHD principal investigator
National Institute for the Control of Pharmaceutical and Biological Products, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Poliomyelitis Vaccine (Sabin strains) and Inactivated Poliomyelitis Vaccine (Salk strains) in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 2 sites 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 5 inclusion and 12 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants (time frame: fours year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510366, which also lists 1 linked publication.
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 11 Oct 2023.