NCT01709071

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

7 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

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

October 16, 2012

Last Update Submit

February 20, 2014

Conditions

Poliomyelitis

Keywords

VaccinationInactivated poliomyelitis vaccinepoliomyelitisSabin strains

Outcome Measures

Primary Outcomes (1)

  • Number of adverse reactions following vaccination

    5 days or until adverse reactions have resolved

Secondary Outcomes (1)

  • Level of virus neutralizing titers in serum

    28 days after last vaccination

Study Arms (7)

Low dose Sabin-IPV

EXPERIMENTAL

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

Low dose adjuvanted Sabin-IPV

EXPERIMENTAL

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

Middle dose Sabin-IPV

EXPERIMENTAL

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

Middle dose adjuvanted Sabin-IPV

EXPERIMENTAL

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

High dose Sabin-IPV

EXPERIMENTAL

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

High dose adjuvanted Sabin-IPV

EXPERIMENTAL

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

Conventional IPV

ACTIVE COMPARATOR

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

Interventions

IPVDRUG
Also known as: IPV (NVI), Inactivated poliomyelitis vaccine, Inactivated poliovirus vaccine, Inactivated polio vaccine
Conventional IPV
Low dose Sabin-IPVDRUG
Low dose Sabin-IPV
Low dose adjuvanted Sabin-IPVDRUG
Low dose adjuvanted Sabin-IPV
Middle dose Sabin-IPVDRUG
Middle dose Sabin-IPV
Middle dose adjuvanted Sabin-IPVDRUG
Middle dose adjuvanted Sabin-IPV
High dose Sabin-IPVDRUG
High dose Sabin-IPV
High dose adjuvanted Sabin-IPVDRUG
High dose adjuvanted Sabin-IPV

Eligibility Criteria

Age56 Days - 63 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

NZOZ Centrum Zdrowia "Błonie"

Bydgoszcz, Poland

Location

Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"

Krakow, Poland

Location

Szpital im. Jana Pawła II

Krakow, Poland

Location

Samodzielny Publiczny ZOZ

Lubartów, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego "Eskulap"

Lublin, Poland

Location

NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk

Siemianowice Śląskie, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.

Tarnów, Poland

Location

Related Publications (4)

  • 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: 21651934BACKGROUND

  • 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: 21604984BACKGROUND

  • 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: 24063976BACKGROUND

  • 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.

    PMID: 25043278DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

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 MixturesPoliovirus VaccinesViral Vaccines

Study Officials

  • Pauline Verdijk, PhD

    National Institute for Public Health and the Environment (RIVM)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Scientist

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 17, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

May 1, 2013

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

PL(7)