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Safety and Immunogenicity of IPOVAC in Young Children

NCT ID: NCT02775942

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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

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Poliomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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IPOVAC 1.5:5:5

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

Group Type EXPERIMENTAL

IPOVAC 1.5:5:5

Intervention Type BIOLOGICAL

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 3:10:10

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

Group Type EXPERIMENTAL

IPOVAC, 3:10:10

Intervention Type BIOLOGICAL

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 6:20:20

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

Group Type EXPERIMENTAL

IPOVAC, 6:20:20

Intervention Type BIOLOGICAL

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

IMOVAC-POLIO

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

Group Type ACTIVE_COMPARATOR

IMOVAC-POLIO

Intervention Type BIOLOGICAL

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

Interventions

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IMOVAC-POLIO

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

Intervention Type BIOLOGICAL

IPOVAC 1.5:5:5

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

Intervention Type BIOLOGICAL

IPOVAC, 3:10:10

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

Intervention Type BIOLOGICAL

IPOVAC, 6:20:20

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

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOVAC IPOVAC-low IPOVAC-medium IPOVAC-high

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Technology, Vietnam

OTHER_GOV

Sponsor Role collaborator

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Dang Duc Anh

General Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dang D Anh, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Hygiene and Epidemiology, Vietnam

Locations

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Preventive Medicine center

Thanh Sơn, Phu Tho, Vietnam

Site Status

Phu Tho Preventive Medicine Center

Việt Trì, Phu Tho, Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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2015-IPOVAC-02

Identifier Type: -

Identifier Source: org_study_id