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PoliomyelitisPhase 2Sabin IPVNCT01056705

The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)

A Phase 2 study testing Inactivated Poliomyelitis Vaccine (Sabin strains), Oral Poliomyelitis Vaccine and Inactivated Poliomyelitis Vaccine (Salk strains). in people with Poliomyelitis, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ 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), Oral Poliomyelitis Vaccine and Inactivated Poliomyelitis Vaccine (Salk strains).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteChina
Study dates
Jul 2009to Aug 2010
Phase
Phase 2
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

1 site in 1 country.

China1 site

  • Pingle Center for Disease Control and Prevention

    Pingle County, Guangxi, 542400

Other trials in China

About this study

Official title: The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ 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 type1, 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. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.

This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.

Conditions
Poliomyelitis
Being tested
Inactivated Poliomyelitis Vaccine (Sabin strains), Oral Poliomyelitis Vaccine, 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) formulation A. 3x0.5ml intramuscular injections,one month apart.

  • Inactivated Poliomyelitis Vaccine (Sabin strains)Biological

    Also called Sabin IPV

    Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.

  • Inactivated Poliomyelitis Vaccine (Sabin strains)Biological

    Also called Sabin IPV

    Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.

  • Oral Poliomyelitis VaccineBiological

    Also called OPV

    Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.

  • Inactivated Poliomyelitis Vaccine (Salk strains).Biological

    Also called Salk IPV

    3x0.5ml intramuscular injections, one month apart.

Study groups in NCT01056705
Study groupRoleWhat they receive
Cohort 1: Experiment InfantsExperimentalBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;
Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Cohort 2: Experiment infantsExperimentalBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;
Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Cohort 3: Experiment infantsExperimentalBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;
Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)
Cohort 4: Experiment infantsExperimentalBiological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral;
Receives: Biological: Oral Poliomyelitis Vaccine
Cohort 5: Experiment infantsExperimentalBiological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml 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.

  1. To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants .

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionMay 2010
  4. Study completionAug 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01056705
Sponsor's protocol ID
imbcams-02
Other IDs
SFDA2007L02021
Acronym
Sabin IPV
Status last verified
Jul 2016
First submitted
25 Jan 2010
Last updated
2 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110.

    PubMed 28419204

  • Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.

    PubMed 22158682

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inactivated Poliomyelitis Vaccine (Sabin strains), Oral Poliomyelitis Vaccine and Inactivated Poliomyelitis Vaccine (Salk strains). 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 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 2 Aug 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants . (time frame: one 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 NCT01056705, which also lists 2 linked publications.

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 2 Aug 2016.

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