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PoliomyelitisPhase 3NCT03016949

A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

A Phase 3 study testing IPV and f-IPV in people with Poliomyelitis, run by Fidec Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID). Read more about this study

Who is it for?
Ages 5 to 7 weeksHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
IPV and f-IPV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2017to Nov 2018
Phase
Phase 3
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 5 to 7 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination
  • Healthy, as assessed from medical history and physical examination by a study physician
  • Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures

Who cannot join

  • Vaccinated with any poliovirus vaccine prior to inclusion
  • A household contact with OPV vaccination history in the past 4 weeks
  • HIV infection or pharmacologic immunosuppression.
  • Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)
  • Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections.
  • Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination.
  • Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.

About this study

Official title: A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants

The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).

Read the detailed description

The study will be conducted in a setting where only IPV is being used for polio prevention in infant immunization schedules.

The study population will include infants from Uruguay, a pioneer country in immunization programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012, after which the program changed to an all-IPV schedule without transition.

The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6 months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.

Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36 weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate vaccine, Rotavirus and will be administered concomitantly.

Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule will be recommended for the post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.

Conditions
Poliomyelitis
Being tested
IPV, f-IPV
Medical subject headings
Poliomyelitis

What participants receive

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

  • IPVBiological

    Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

  • f-IPVBiological

    Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Study groups in NCT03016949
Study groupRoleWhat they receive
Group AExperimental3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 18, 36 \& 40 weeks.
Receives: Biological: IPV
Group BExperimental3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 18, 36 \& 40 weeks.
Receives: Biological: f-IPV
Group CExperimental2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
Receives: Biological: IPV
Group DExperimental2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
Receives: Biological: f-IPV
Group EExperimental3 doses IPV IM at 6, 14 \& 36 weeks of age incl. blood sampling at 6, 18, 36 \& 40 weeks.
Receives: Biological: IPV
Group FExperimental3 doses f-IPV ID at 6, 14 \& 36 weeks of age incl. blood sampling at 6, 18, 36 \& 40 weeks.
Receives: Biological: f-IPV

What is being measured

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

  1. Seroconversion

    Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.

    Measured: To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.

Secondary outcomes (5)

  1. Seroconversion

    Measured: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.

  2. Median titers

    Measured: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.

  3. SAEs (Serious Adverse Events)

    Measured: To be assessed throughout the complete study period, approx. 18 months.

  4. IMEs (Important Medical Events)

    These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.

    Measured: To be assessed throughout the complete study period, approx. 18 months.

  5. Severe local reactions

    Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.

    Measured: To be assessed throughout the complete study period, approx. 18 months.

Timeline

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

  1. First posted11 Jan 2017 (estimated)
  2. Study startJul 2017 (estimated)
  3. Primary completionOct 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Why it stopped: Regulatory timelines for approval expired

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016949
Sponsor's protocol ID
IPV-003-ABMG
Status last verified
Jun 2017
First submitted
5 Jan 2017
Last updated
27 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPV and f-IPV in people with Poliomyelitis, run by Fidec Corporation.

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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Seroconversion (time frame: To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.). 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 NCT03016949.

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 27 Jun 2017.

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