Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

February 20, 2014 updated by: Pauline Verdijk

Double Blind Dose - Escalation, Randomized, Controlled, Phase I-II Trial to Evaluate Safety and Immunogenicity of Three Doses of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Infants

A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

  • The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.
  • The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland
        • NZOZ Centrum Zdrowia "Błonie"
      • Krakow, Poland
        • Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
      • Krakow, Poland
        • Szpital im. Jana Pawła II
      • Lubartów, Poland
        • Samodzielny Publiczny ZOZ
      • Lublin, Poland
        • NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"
      • Siemianowice Śląskie, Poland
        • NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk
      • Tarnów, Poland
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 8 weeks (56-63 days) at the time of first vaccination
  • Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
  • The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
  • Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion Criteria:

  • Any IPV or OPV dose
  • Known or suspected allergy against any of the vaccine components
  • History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
  • Any vaccination less than 14 days before or after each vaccination with the IMP
  • History of any neurological disorder including epilepsy or febrile seizures
  • Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
  • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
  • Any known or suspected primary or secondary immunodeficiency
  • Communication problems interfering in the study realization according to the judgment of the investigator
  • Bleeding disorders and use of anticoagulants
  • Premature birth (<37 weeks)
  • Participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: Low dose Sabin-IPV
Experimental: Low dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 2.5, 4, 8 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: Low dose adjuvanted Sabin-IPV
Experimental: Middle dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: Middle dose Sabin-IPV
Experimental: Middle dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: Middle dose adjuvanted Sabin-IPV
Experimental: High dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: High dose Sabin-IPV
Experimental: High dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.
Drug: High dose adjuvanted Sabin-IPV
Active Comparator: Conventional IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose.

Infants receive three injections with an interval of 8 weeks between doses.
Drug: IPV
Other Names:
  • IPV (NVI)
  • Inactivated poliomyelitis vaccine
  • Inactivated poliovirus vaccine
  • Inactivated polio vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse reactions following vaccination
Time Frame: 5 days or until adverse reactions have resolved
5 days or until adverse reactions have resolved

Secondary Outcome Measures

Outcome Measure
Time Frame
Level of virus neutralizing titers in serum
Time Frame: 28 days after last vaccination
28 days after last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pauline Verdijk

Collaborators

World Health Organization

Investigators

  • Study Director: Pauline Verdijk, PhD, National Institute for Public Health and the Environment (RIVM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVI-256B
  • 2011-003792-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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