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Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults

NCT01997632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-10

No results posted yet for this study

Summary

The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults.

If the study vaccine appears to be safe, it will be tested at a later stage in the target group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the purpose is to use the study vaccine in the future to protect young children against Polio serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young children to come to a complete eradication of Polio is needed. The standard use of Imovax to protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has been developed.

The duration of the study will be approximately 6 months. 120 subjects between 18 and 45 years of age will participate in Belgium.

During the study there will be 2 groups of subjects. Subjects will be assigned by chance to one of these groups. One group will receive one single injection of the study vaccine m-IPV2 HD (which contains only serotype 2), the other group will receive one single injection of the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).

After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked to come to the study centre one more time for the second visit (on Day 8, which is 7 days after the first visit). They will also receive 2 follow-up phone calls for approximately one month and 6 months after vaccination.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)

a single dose m-IPV2 HD (study vaccine), 0,5ml

BIOLOGICAL

a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).

a single 0.5 ml dose Imovax Polio (control vaccine)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Geert Leroux-Roels, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997632 on ClinicalTrials.gov