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PoliomyelitisPhase 2NCT02775942

Safety and Immunogenicity of IPOVAC in Young Children

A Phase 2 study testing IMOVAC-POLIO, IPOVAC 1.5:5:5 and IPOVAC, 3:10:10 in people with Poliomyelitis, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

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

A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Read more about this study

Who is it for?
Ages 2 months and olderHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
IMOVAC-POLIO, IPOVAC 1.5:5:5 and IPOVAC, 3:10:10
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesVietnam
Study dates
Nov 2015to 31 Oct 2016
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 2 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Children of both sexes, 2 months of ages
  • Full term babies (>=37 weeks)
  • Weight at birth (>=2500gr)
  • Have not been vaccinated with polio vaccine or vaccine containing poliovirus components
  • Not currently have acute infection (assessed via clinical check up and asking parents/care givers about health history before enrolment
  • Parents/legal guardians agree to participate their children in this study and sign the informed consent.

Who cannot join

  • Currently have chronic diseases (cardiovascular, liver and spleen related etc)
  • Use (orally or through infection) with corticoid containing drug (>1mg/kg dose)
  • Use of immunocompromised treatment within 4 weeks of enrolment
  • Being immunocompromised and autoimmune diseases (HIV, lupus)
  • the history of immunocompromised in the family
  • history of high fever
Show all 11Show fewer
  • Allergic for any vaccine component
  • Fever (>38oC) within 3 days before vaccination or at enrolment
  • Malnourished (3rd level or above)
  • Blood disorder
  • use of vaccines which have not been licences 7 days before enrolment in this study

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • Preventive Medicine center

    Thanh Sơn, Phu Tho

  • Phu Tho Preventive Medicine Center

    Viet Tri, Phu Tho

Other trials in Vietnam

About this study

Official title: Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children

A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for each of vaccine serotypes.

Read the detailed description

The use of oral poliomyelitis vaccine (OPV) in Vietnam expanded immunisation program has resulted in successful eradication of polio in Vietnam. However due to the concern of OPV-related poliomyelitis cases occurred worldwide, WHO has recommended the countries to gradually change to inactivated polio vaccine (IPV). In Vietnam, POLYVAC has been approved and sponsored by the Ministry of Science and Technology to produce IPV under Japanese technology. The vaccine consisting of 3 serotypes (Serotype 1,2 and 3) has been proven safety in volunteer adults.

In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues evaluated include immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Seroconversion rates of neutralising antibodies for each of vaccine serotypes are to be assessed.

Conditions
Poliomyelitis
Being tested
IMOVAC-POLIO, IPOVAC 1.5:5:5, IPOVAC, 3:10:10, IPOVAC, 6:20:20
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMOVAC-POLIOBiological

    Also called IMOVAC

    IMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval

  • IPOVAC 1.5:5:5Biological

    Also called IPOVAC-low

    IPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form

  • IPOVAC, 3:10:10Biological

    Also called IPOVAC-medium

    IPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form

  • IPOVAC, 6:20:20Biological

    Also called IPOVAC-high

    IPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form

Study groups in NCT02775942
Study groupRoleWhat they receive
IPOVAC 1.5:5:5ExperimentalIPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
Receives: Biological: IPOVAC 1.5:5:5
IPOVAC 3:10:10ExperimentalIPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
Receives: Biological: IPOVAC, 3:10:10
IPOVAC 6:20:20ExperimentalIPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
Receives: Biological: IPOVAC, 6:20:20
IMOVAC-POLIOActive comparatorIMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval
Receives: Biological: IMOVAC-POLIO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events after each dose of vaccine

    Number of participants with treatment-related adverse events after each dose of vaccine, immediately after vaccination (within 30 min), within 7 days and 30 days of vaccination, as assessed by CTCAE v.4.0

    Measured: Upto 30 days after each dose

  2. Number of participants with 4-fold or more increase in in antibody titers after 2 or 3 doses of vaccine (compared to pre-vaccination)

    Seroconversion rate of each IPOVAC regimen and IMOVAC after 2 or 3 doses of vaccines

    Measured: Upto 30 days after the final dose

Secondary outcomes (2)

  1. Number of participants with treatment-related SAE after each vaccination dose

    Number of participants with treatment-related SAE after each vaccination doses of IPOVAC compared to that of IMOVAC, as assessed by CTCAE ver 4.0

    Measured: Upto 30 days after vaccine dose

  2. Number of participants with abnormal laboratory value

    Numbers of participants with abnormal laboratory values (blood cell counts, urea concentration, liver function (ALT, AST concentration) when administered with different IPOVAC formulations and with IMOVAC before and after each dose of vaccination

    Measured: Upto 30 days after each vaccine dose

Timeline

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

  1. First posted18 May 2016 (estimated)
  2. Study startNov 2015
  3. Primary completion25 Jul 2016
  4. Study completion31 Oct 2016

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
Participant
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775942
Sponsor's protocol ID
2015-IPOVAC-02
Status last verified
May 2016
First submitted
5 May 2016
Last updated
29 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMOVAC-POLIO, IPOVAC 1.5:5:5 and IPOVAC, 3:10:10 in people with Poliomyelitis, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

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 6 inclusion and 11 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 29 Jun 2017. 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 Vietnam. 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?

Number of participants with treatment-related adverse events after each dose of vaccine (time frame: Upto 30 days after each dose). 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?

On the ClinicalTrials.gov record for NCT02775942.

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 Jun 2017.

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