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Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
IPV
Low dose Sabin-IPV
Low dose adjuvanted Sabin-IPV
Middle dose Sabin-IPV
Middle dose adjuvanted Sabin-IPV
High dose Sabin-IPV
High dose adjuvanted Sabin-IPV
Sponsored by
Pauline Verdijk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Vaccination, Inactivated poliomyelitis vaccine, poliomyelitis, Sabin strains

Eligibility Criteria

56 Days - 63 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NZOZ Centrum Zdrowia "Błonie"
  • Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
  • Szpital im. Jana Pawła II
  • Samodzielny Publiczny ZOZ
  • NZOZ Praktyka Lekarza Rodzinnego "Eskulap"
  • NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Low dose Sabin-IPV

Low dose adjuvanted Sabin-IPV

Middle dose Sabin-IPV

Middle dose adjuvanted Sabin-IPV

High dose Sabin-IPV

High dose adjuvanted Sabin-IPV

Conventional IPV

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of adverse reactions following vaccination

Secondary Outcome Measures

Level of virus neutralizing titers in serum

Full Information

First Posted
October 16, 2012
Last Updated
February 20, 2014
Sponsor
Pauline Verdijk
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01709071
Brief Title
Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pauline Verdijk
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Vaccination, Inactivated poliomyelitis vaccine, poliomyelitis, Sabin strains

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
Low dose adjuvanted Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
Middle dose Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
Middle dose adjuvanted Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
High dose Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
High dose adjuvanted Sabin-IPV
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional IPV
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IPV
Other Intervention Name(s)
IPV (NVI), Inactivated poliomyelitis vaccine, Inactivated poliovirus vaccine, Inactivated polio vaccine
Intervention Type
Drug
Intervention Name(s)
Low dose Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
Low dose adjuvanted Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
Middle dose Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
Middle dose adjuvanted Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
High dose Sabin-IPV
Intervention Type
Drug
Intervention Name(s)
High dose adjuvanted Sabin-IPV
Primary Outcome Measure Information:
Title
Number of adverse reactions following vaccination
Time Frame
5 days or until adverse reactions have resolved
Secondary Outcome Measure Information:
Title
Level of virus neutralizing titers in serum
Time Frame
28 days after last vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Days
Maximum Age & Unit of Time
63 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Verdijk, PhD
Organizational Affiliation
National Institute for Public Health and the Environment (RIVM)
Official's Role
Study Director
Facility Information:
Facility Name
NZOZ Centrum Zdrowia "Błonie"
City
Bydgoszcz
Country
Poland
Facility Name
Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
City
Krakow
Country
Poland
Facility Name
Szpital im. Jana Pawła II
City
Krakow
Country
Poland
Facility Name
Samodzielny Publiczny ZOZ
City
Lubartów
Country
Poland
Facility Name
NZOZ Praktyka Lekarza Rodzinnego "Eskulap"
City
Lublin
Country
Poland
Facility Name
NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk
City
Siemianowice Śląskie
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.
City
Tarnów
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21651934
Citation
Bakker WA, Thomassen YE, van't Oever AG, Westdijk J, van Oijen MG, Sundermann LC, van't Veld P, Sleeman E, van Nimwegen FW, Hamidi A, Kersten GF, van den Heuvel N, Hendriks JT, van der Pol LA. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine. 2011 Sep 22;29(41):7188-96. doi: 10.1016/j.vaccine.2011.05.079. Epub 2011 Jun 7.
Results Reference
background
PubMed Identifier
21604984
Citation
Verdijk P, Rots NY, Bakker WA. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011 May;10(5):635-44. doi: 10.1586/erv.11.51.
Results Reference
background
PubMed Identifier
24063976
Citation
Verdijk P, Rots NY, van Oijen MG, Oberste MS, Boog CJ, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine. 2013 Nov 12;31(47):5531-6. doi: 10.1016/j.vaccine.2013.09.021. Epub 2013 Sep 21.
Results Reference
background
PubMed Identifier
25043278
Citation
Verdijk P, Rots NY, van Oijen MG, Weldon WC, Oberste MS, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of a primary series of Sabin-IPV with and without aluminum hydroxide in infants. Vaccine. 2014 Sep 3;32(39):4938-44. doi: 10.1016/j.vaccine.2014.07.029. Epub 2014 Jul 18.
Results Reference
derived

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Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

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