PoliomyelitisPhase 3NCT03239496

A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

A Phase 3 study testing IPV and f-IPV in people with Poliomyelitis, run by Fidec Corporation at 4 sites in 2 countries.

Completed

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

Trial summary

The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization… 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: 773 participants
Where: 4 sitesin 2 countries
Study dates: 23 Oct 2017to 13 Nov 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 enrollment.
Healthy, as assessed from medical history and physical examination by a study physician,
Written informed consent obtained from parents or legal representatives who 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(s) to be a contraindication for vaccination,
Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Panama3 sites

Cevaxin Vaccination Center
David
Cevaxin Vaccination Center
La Chorrera
Cevaxin Vaccination Center
Panama City

Other trials in Panama

Dominican Republic1 site

Hospital Universitario Nuestra Señora de la Alta Gracia
Santo Domingo

Other trials in Dominican Republic

About this study

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

Read the detailed description

This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21. Furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era.

The study population will include infants in Dominican Republic and Panama. Absence of wild and circulating vaccine derived polioviruses along with the lack of regular Supplementary Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic setting to study polio vaccine immunogenicity.

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

A total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. During the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on IPV immunogenicity will not be assessed.

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 are optimal for the post-eradication era after the global cessation of Oral Polio Vaccine (OPV) use.

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 NCT03239496
Study group	Role	What they receive
Group A	Experimental	3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks. Receives: Biological: IPV
Group B	Experimental	2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks. Receives: Biological: IPV
Group C	Experimental	3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks. Receives: Biological: f-IPV
Group D	Experimental	2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 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.

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose

Secondary outcomes (6)

Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the second dose
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the second dose
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Measured: To be assessed 4 weeks after the last dose
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).
Measured: 9 months

Timeline

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

23 Oct 201713 Nov 2018

First posted4 Aug 2017
Study start23 Oct 2017
Primary completion13 Nov 2018
Study completion13 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PoliomyelitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 773 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03239496
Sponsor's protocol ID: IPV004
Status last verified: Jul 2023
First submitted: 28 Jul 2017
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bandyopadhyay AS, Gast C, Rivera L, Saez-Llorens X, Oberste MS, Weldon WC, Modlin J, Clemens R, Costa Clemens SA, Jimeno J, Ruttimann R. Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: a randomised open-label, multicentre, phase 3, non-inferiority trial. Lancet Infect Dis. 2021 Apr;21(4):559-568. doi: 10.1016/S1473-3099(20)30555-7. Epub 2020 Oct 23.
PubMed 33284114

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Poliomyelitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants
ClinicalTrials.gov ID: NCT03239496
Acronym / sponsor ID: IPV004
Conditions: Poliomyelitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 773 participants (actual)
Lead sponsor: Fidec CorporationUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation
Study start: 23 Oct 2017 (actual)
Primary completion: 13 Nov 2018 (actual)
Study completion: 13 Nov 2018 (actual)
First posted: 4 Aug 2017 (actual)
Results: Posted 18 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Biological: IPV3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
Group B	Experimental	Biological: IPV2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
Group C	Experimental	Biological: f-IPV3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
Group D	Experimental	Biological: f-IPV2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.

Who may qualify

Ages: 5 to 7 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IPVComparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)	Biological	Group A, Group B
f-IPVComparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)	Biological	Group C, Group D

Primary outcome

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
Time frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
Time frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
Time frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.

6 secondary outcomes

Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
Time frame: To be assessed 4 weeks after the second dose
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
Time frame: To be assessed 4 weeks after the second dose
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
Time frame: To be assessed 4 weeks after the last dose
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
Time frame: 9 months

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A - 3 Doses IPV IM	200	186
Group B - 2 Doses IPV IM	178	168
Group C - 3 Doses f-IPV	178	166
Group D - 2 Doses f-IPV ID	217	203

Primary outcome: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM

Time frame: To be assessed 4 weeks after the last dose. Mean (95% Confidence Interval). Unit: percentage of seroconversion

Measure	Group B n = 159	Group D n = 195
Serotype 1	98.1 (94.6 to 99.6)	95.9 (92.1 to 98.2)
Serotype 2	98.7 (95.5 to 99.8)	97.9 (94.8 to 99.4)

Group B vs Group D: p = 0.05, t-test, 1 sided

Population analysed: Per Protocol Population (692 subjects) is used for this assessment. The participants flow includes the Intended to Treat population (773 subjects).

Primary outcome: Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM

Time frame: To be assessed 4 weeks after the last dose. Mean (95% Confidence Interval). Unit: percentage of seroconversion

Measure	Group A n = 159	Group B n = 178
Serotype 1	100 (97.9 to 100)	98.1 (94.6 to 99.6)
Serotype 2	100 (97.9 to 100)	98.7 (95.5 to 99.8)

Group A vs Group B: p = 0.05, t-test, 2 sided

Population analysed: Per Protocol Population

Primary outcome: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID

Time frame: To be assessed 4 weeks after the last dose. Mean (95% Confidence Interval). Unit: percentage of seroconversion

Measure	Group C n = 160	Group D n = 195
Serotype 1	98.8 (95.6 to 98.8)	95.9 (92.1 to 98.2)
Serotype 2	100 (97.7 to 100)	97.9 (94.8 to 99.4)

Group C vs Group D: p = 0.05, t-test, 2 sided

Population analysed: Per Protocol Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	12 of 195 (6.2%)	7 of 195 (3.6%)	1 of 195
Group B	7 of 172 (4.1%)	0 of 172 (0%)	0 of 172
Group C	9 of 170 (5.3%)	4 of 170 (2.4%)	0 of 170
Group D	9 of 207 (4.3%)	2 of 207 (1%)	0 of 207

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33284114Bandyopadhyay AS, Gast C, Rivera L, Saez-Llorens X, Oberste MS, Weldon WC, Modlin J, Clemens R, Costa Clemens SA, Jimeno J, Ruttimann R. Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: a randomised open-label, multicentre, phase 3, non-inferiority trial. Lancet Infect Dis. 2021 Apr;21(4):559-568. doi: 10.1016/S1473-3099(20)30555-7. Epub 2020 Oct 23.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 2 countries: see every site and its status.

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 at 4 sites in 2 countries.

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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Panama, Dominican Republic. 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 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?

Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM (time frame: To be assessed 4 weeks after the last dose). The study lists 3 primary outcomes in all. 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 NCT03239496, which also lists 1 linked publication.

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 Jul 2023.