NCT02775942

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
Last Updated

June 29, 2017

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 5, 2016

Last Update Submit

June 28, 2017

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

  • 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

    Upto 30 days after each dose

  • 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

    Upto 30 days after the final dose

Secondary Outcomes (2)

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

    Upto 30 days after vaccine dose

  • Number of participants with abnormal laboratory value

    Upto 30 days after each vaccine dose

Study Arms (4)

IPOVAC 1.5:5:5

EXPERIMENTAL

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

Biological: IPOVAC 1.5:5:5

IPOVAC 3:10:10

EXPERIMENTAL

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

Biological: IPOVAC, 3:10:10

IPOVAC 6:20:20

EXPERIMENTAL

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

Biological: IPOVAC, 6:20:20

IMOVAC-POLIO

ACTIVE COMPARATOR

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

Biological: IMOVAC-POLIO

Interventions

IMOVAC-POLIOBIOLOGICAL

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

Also known as: IMOVAC
IMOVAC-POLIO
IPOVAC 1.5:5:5BIOLOGICAL

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

Also known as: IPOVAC-low
IPOVAC 1.5:5:5
IPOVAC, 3:10:10BIOLOGICAL

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

Also known as: IPOVAC-medium
IPOVAC 3:10:10
IPOVAC, 6:20:20BIOLOGICAL

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

Also known as: IPOVAC-high
IPOVAC 6:20:20

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Preventive Medicine center

Thanh Sơn, Phu Tho, Vietnam

Location

Phu Tho Preventive Medicine Center

Việt Trì, Phu Tho, Vietnam

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Dang D Anh, PhD

    National Institute of Hygiene and Epidemiology, Vietnam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Director

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 18, 2016

Study Start

November 1, 2015

Primary Completion

July 25, 2016

Study Completion

October 31, 2016

Last Updated

June 29, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

VN(2)