<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709071</url>
  </required_header>
  <id_info>
    <org_study_id>NVI-256B</org_study_id>
    <secondary_id>2011-003792-11</secondary_id>
    <nct_id>NCT01709071</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pauline Verdijk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute for Public Health and the Environment (RIVM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new inactivated polio vaccine based on attenuated poliovirus strains was developed to&#xD;
      transfer the technology to manufacturers in low- and middle-income countries. This vaccine&#xD;
      was produced in different dosages and in different formulations. In healthy adults the safety&#xD;
      of the highest dose was comparable to that of the existing inactivated polio vaccine. The&#xD;
      purpose of this trial is to determine the safety of the different dosages and formulations of&#xD;
      the vaccine in infants. The second goal of this study is to analyse the immune response after&#xD;
      three doses in infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted&#xD;
      Sabin-IPV produced with the production process set up for technology transfer by the National&#xD;
      Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine&#xD;
      Institute (NVI).&#xD;
&#xD;
        -  The primary objective is to evaluate safety (local and systemic reactions) of&#xD;
           intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.&#xD;
&#xD;
        -  The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and&#xD;
           adjuvanted Sabin-IPV in infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse reactions following vaccination</measure>
    <time_frame>5 days or until adverse reactions have resolved</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of virus neutralizing titers in serum</measure>
    <time_frame>28 days after last vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Low dose Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose adjuvanted Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle dose Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle dose adjuvanted Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose adjuvanted Sabin-IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Infants receive three vaccinations with an interval of 8 weeks between doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
Infants receive three injections with an interval of 8 weeks between doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPV</intervention_name>
    <arm_group_label>Conventional IPV</arm_group_label>
    <other_name>IPV (NVI)</other_name>
    <other_name>Inactivated poliomyelitis vaccine</other_name>
    <other_name>Inactivated poliovirus vaccine</other_name>
    <other_name>Inactivated polio vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose Sabin-IPV</intervention_name>
    <arm_group_label>Low dose Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose adjuvanted Sabin-IPV</intervention_name>
    <arm_group_label>Low dose adjuvanted Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Middle dose Sabin-IPV</intervention_name>
    <arm_group_label>Middle dose Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Middle dose adjuvanted Sabin-IPV</intervention_name>
    <arm_group_label>Middle dose adjuvanted Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose Sabin-IPV</intervention_name>
    <arm_group_label>High dose Sabin-IPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose adjuvanted Sabin-IPV</intervention_name>
    <arm_group_label>High dose adjuvanted Sabin-IPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 8 weeks (56-63 days) at the time of first vaccination&#xD;
&#xD;
          -  Infants in good general health, eligible to be vaccinated according to the Polish&#xD;
             national vaccination program. The same health criteria apply as used in well-baby&#xD;
             clinics when a child receives a vaccination, e.g. also children with a small increase&#xD;
             in temperature (&lt; 38.5° C) or with a common cold (runny nose etc) are seen as children&#xD;
             with normal health.&#xD;
&#xD;
          -  The parent(s)/legally representative(s) have to be willing and able to allow their&#xD;
             child to participate in the trial according to the described procedures&#xD;
&#xD;
          -  Presence of a signed informed consent in which the parent(s)/legally representative(s)&#xD;
             have given written informed consent after receiving oral and written information&#xD;
             (signature from one parent in case of single-parent family).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any IPV or OPV dose&#xD;
&#xD;
          -  Known or suspected allergy against any of the vaccine components&#xD;
&#xD;
          -  History of unusual or severe reactions to any previous vaccination administration of&#xD;
             plasma (including immunoglobulins) or blood products prior and during the study&#xD;
&#xD;
          -  Any vaccination less than 14 days before or after each vaccination with the IMP&#xD;
&#xD;
          -  History of any neurological disorder including epilepsy or febrile seizures&#xD;
&#xD;
          -  Any infectious disease at the time of screening and/or inclusion that might interfere&#xD;
             with the results of the study&#xD;
&#xD;
          -  Present evidence of serious disease(s) demanding immunosuppressive medical treatment,&#xD;
             like cytostatics and prednisolones, that might interfere with the results of the study&#xD;
&#xD;
          -  Any known or suspected primary or secondary immunodeficiency&#xD;
&#xD;
          -  Communication problems interfering in the study realization according to the judgment&#xD;
             of the investigator&#xD;
&#xD;
          -  Bleeding disorders and use of anticoagulants&#xD;
&#xD;
          -  Premature birth (&lt;37 weeks)&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>56 Days</minimum_age>
    <maximum_age>63 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pauline Verdijk, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Institute for Public Health and the Environment (RIVM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NZOZ Centrum Zdrowia &quot;Błonie&quot;</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczna Poradnia Medyczna &quot;Przylądek Zdrowia&quot;</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital im. Jana Pawła II</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny ZOZ</name>
      <address>
        <city>Lubartów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Praktyka Lekarza Rodzinnego &quot;Eskulap&quot;</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk</name>
      <address>
        <city>Siemianowice Śląskie</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.</name>
      <address>
        <city>Tarnów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21651934</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21604984</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24063976</PMID>
  </reference>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>February 20, 2014</last_update_submitted>
  <last_update_submitted_qc>February 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Institute for Public Health and the Environment (RIVM)</investigator_affiliation>
    <investigator_full_name>Pauline Verdijk</investigator_full_name>
    <investigator_title>Clinical Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Vaccination</keyword>
  <keyword>Inactivated poliomyelitis vaccine</keyword>
  <keyword>poliomyelitis</keyword>
  <keyword>Sabin strains</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709071
org study id: NVI-256B
secondary id: 2011-003792-11
nct id: NCT01709071
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of adverse reactions following vaccination
time frame: 5 days or until adverse reactions have resolved
measure: Level of virus neutralizing titers in serum
time frame: 28 days after last vaccination
arm group label: Low dose Sabin-IPV
arm group type: Experimental
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 group label: Low dose adjuvanted Sabin-IPV
arm group type: Experimental
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 group label: Middle dose Sabin-IPV
arm group type: Experimental
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 group label: Middle dose adjuvanted Sabin-IPV
arm group type: Experimental
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 group label: High dose Sabin-IPV
arm group type: Experimental
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 group label: High dose adjuvanted Sabin-IPV
arm group type: Experimental
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 group label: Conventional IPV
arm group type: Active Comparator
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: IPV
arm group label: Conventional IPV
other name: IPV (NVI)
other name: Inactivated poliomyelitis vaccine
other name: Inactivated poliovirus vaccine
other name: Inactivated polio vaccine
intervention type: Drug
intervention name: Low dose Sabin-IPV
arm group label: Low dose Sabin-IPV
intervention type: Drug
intervention name: Low dose adjuvanted Sabin-IPV
arm group label: Low dose adjuvanted Sabin-IPV
intervention type: Drug
intervention name: Middle dose Sabin-IPV
arm group label: Middle dose Sabin-IPV
intervention type: Drug
intervention name: Middle dose adjuvanted Sabin-IPV
arm group label: Middle dose adjuvanted Sabin-IPV
intervention type: Drug
intervention name: High dose Sabin-IPV
arm group label: High dose Sabin-IPV
intervention type: Drug
intervention name: High dose adjuvanted Sabin-IPV
arm group label: High dose adjuvanted Sabin-IPV
criteria: 
gender: All
minimum age: 56 Days
maximum age: 63 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Pauline Verdijk, PhD
role: Study Director
affiliation: National Institute for Public Health and the Environment (RIVM)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
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.
PMID: 21651934
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.
PMID: 21604984
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.
PMID: 24063976
responsible party type: Sponsor-Investigator
investigator affiliation: National Institute for Public Health and the Environment (RIVM)
investigator full name: Pauline Verdijk
investigator title: Clinical Research Scientist
mesh term: Poliomyelitis
mesh term: Vaccines