AzTrials
AzTrials

PoliomyelitisPhase 1/2NCT01709071

Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

A Phase 1/2 study testing IPV, Low dose Sabin-IPV and Low dose adjuvanted Sabin-IPV in people with Poliomyelitis, run by Pauline Verdijk at 7 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 56 to 63 daysHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
IPV, Low dose Sabin-IPV and Low dose adjuvanted Sabin-IPV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
7 sitesPoland
Study dates
Feb 2012to May 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 to 63 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Poland7 sites

  • NZOZ Centrum Zdrowia "Błonie"

    Bydgoszcz

  • Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"

    Krakow

  • Szpital im. Jana Pawła II

    Krakow

  • Samodzielny Publiczny ZOZ

    Lubartów

  • NZOZ Praktyka Lekarza Rodzinnego "Eskulap"

    Lublin

  • NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk

    Siemianowice Śląskie

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

    Tarnów

Other trials in Poland

About this study

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

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.

Read the 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.
Conditions
Poliomyelitis
Being tested
IPV, Low dose Sabin-IPV, Low dose adjuvanted Sabin-IPV, Middle dose Sabin-IPV, Middle dose adjuvanted Sabin-IPV
Keywords
Vaccination, Inactivated poliomyelitis vaccine, poliomyelitis, Sabin strains
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPVDrug

    Also called IPV (NVI), Inactivated poliomyelitis vaccine, Inactivated poliovirus vaccine, Inactivated polio vaccine

  • Low dose Sabin-IPVDrug

  • Low dose adjuvanted Sabin-IPVDrug

  • Middle dose Sabin-IPVDrug

  • Middle dose adjuvanted Sabin-IPVDrug

  • High dose Sabin-IPVDrug

  • High dose adjuvanted Sabin-IPVDrug

Study groups in NCT01709071
Study groupRoleWhat they receive
Low dose Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: Low dose Sabin-IPV
Low dose adjuvanted Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: Low dose adjuvanted Sabin-IPV
Middle dose Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: Middle dose Sabin-IPV
Middle dose adjuvanted Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: Middle dose adjuvanted Sabin-IPV
High dose Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: High dose Sabin-IPV
High dose adjuvanted Sabin-IPVExperimentalIntramuscular 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.
Receives: Drug: High dose adjuvanted Sabin-IPV
Conventional IPVActive comparatorIntramuscular 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.
Receives: Drug: IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse reactions following vaccination

    Measured: 5 days or until adverse reactions have resolved

Secondary outcomes (1)

  1. Level of virus neutralizing titers in serum

    Measured: 28 days after last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionNov 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01709071
Sponsor's protocol ID
NVI-256B
Other IDs
2011-003792-11
Status last verified
Feb 2014
First submitted
16 Oct 2012
Last updated
21 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21651934

  • 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.

    PubMed 21604984

  • 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.

    PubMed 24063976

  • 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.

    PubMed 25043278

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IPV, Low dose Sabin-IPV and Low dose adjuvanted Sabin-IPV in people with Poliomyelitis, run by Pauline Verdijk at 7 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse reactions following vaccination (time frame: 5 days or until adverse reactions have resolved). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01709071, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in