NCT00348387

Brief Summary

This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

July 3, 2006

Last Update Submit

January 20, 2014

Conditions

PoliomyelitisPolio

Keywords

Imovax poliopoliomyelitis

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine

    1 month post-vaccination 3

Secondary Outcomes (1)

  • To provide information concerning the safety of IMOVAX Polio™ vaccine

    Entire study period

Study Arms (2)

Group 1

EXPERIMENTAL
Biological: Poliomyelitis Vaccine inactivated

Group 2

ACTIVE COMPARATOR
Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)

Interventions

Poliomyelitis Vaccine inactivatedBIOLOGICAL

0.5 mL, Intramuscular

Also known as: IMOVAX Polio ™
Group 1
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)BIOLOGICAL

1g dragee, oral

Also known as: Poliomyelitis Vaccine in Dragee Candy
Group 2

Eligibility Criteria

Age60 Days - 70 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
  • Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
  • Able to attend all planned clinic appointment and obey and follow all study instructions

You may not qualify if:

  • Taking part in another clinical trial during the 4 weeks before the first trial vaccination
  • Have plans to take part in another clinical trial d during this trial period
  • Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
  • Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
  • Prolonged or long time illness that could interfere with study or full participation
  • Received blood or blood-derived products since birth
  • Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
  • Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
  • Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
  • History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
  • Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
  • Bleeding disorder or a low platelet which do not allow vaccination into the muscle
  • Had seizures in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Guilin, 541001, China

Location

Unknown Facility

PingLe County, 542400, China

Location

Related Links

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, InactivatedPoliovirus Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines, InactivatedVaccinesBiological ProductsComplex MixturesViral Vaccines

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

CN(2)