CompletedNCT03239496Updated Jul 21, 2023Results posted

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

A Phase 3 interventional study of IPV and f-IPV in Poliomyelitis, sponsored by Fidec Corporation. Completed at 4 sites in 2 countries. Open to participants aged 5 Weeks to 7 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Fidec Corporation · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 773
Allocation: Randomized
Ages: 5 Weeks to 7 Weeks
Sex: All

Study 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 (EPI) primary series.

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 studied

Poliomyelitis

Browse trials for

Poliomyelitis 274

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's enrollment of 773 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Fidec Corporation is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Weeks to 7 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 obtained from parents or legal representatives who have been properly informed about the study and are able to comply with planned study procedures.

Exclusion criteria

Exclusion Criteria:

Vaccinated with any poliovirus vaccine prior to inclusion,
A household contact with OPV vaccination history in the past 4 weeks,
infection or pharmacologic ,
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 for vaccination,
Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 773 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: To be assessed 4 weeks after the last dose

Secondary outcomes

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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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).
Time frame: 9 months

Results

Posted Aug 18, 2020

Participant flow

Participant flow — Overall Study
Milestone	Group A - 3 Doses IPV IM	Group B - 2 Doses IPV IM	Group C - 3 Doses f-IPV	Group D - 2 Doses f-IPV ID
Started	200	178	178	217
Completed	186	168	166	203
Not completed	14	10	12	14

Outcome measures

PrimarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
percentage of seroconversion	Group B	Group D
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)

Statistical analysis

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

PrimarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
percentage of seroconversion	Group A	Group B
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)

Statistical analysis

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

PrimarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
percentage of seroconversion	Group C	Group D
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)

Statistical analysis

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

SecondarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the second dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
percentage of seroconversion	Group A	Group B
Serotype 1	95.6 (94.6 to 99.6)	98.1 (94.6 to 99.6)
Serotype 2	88.9 (83.4 to 93.1)	98.7 (95.5 to 99.8)

Statistical analysis

Group A vs Group B · Fisher Exact · p = 0.0001

SecondarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the second dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
percentage of seroconversion	Group C	Group D
Serotype 1	83.2 (76.5 to 88.6)	95.9 (92.1 to 98.2)
Serotype 2	83.9 (77.2 to 89.2)	97.9 (94.8 to 99.4)

Statistical analysis

Group C vs Group D · Fisher Exact · p = 0.0001

SecondarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
percentage of seroconversion	Group A	Group D
Serotype 1	100 (97.9 to 100)	95.9 (92.1 to 98.2)
Serotype 2	100 (97.9 to 100)	97.9 (94.8 to 99.4)

Statistical analysis

Group A vs Group D · t-test, 2 sided · p = 0.05

SecondarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
percentage of seroconversion	Group A	Group C
Serotype 1	100 (97.9 to 100)	98.8 (95.6 to 99.8)
Serotype 2	100 (97.9 to 100)	100 (97.7 to 100)

Statistical analysis

Group A vs Group C · t-test, 2 sided · p = 0.05

SecondarySeroconversion 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.

Time frame:: To be assessed 4 weeks after the last dose
Reported as:: Mean · percentage of seroconversion

Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
percentage of seroconversion	Group B	Group C
Serotype 1	98.1 (94.6 to 99.6)	98.8 (95.6 to 99.8)
Serotype 2	98.7 (95.5 to 99.8)	100 (97.7 to 100)

Statistical analysis

Group B vs Group C · t-test, 2 sided · p = 0.05

SecondaryNumber 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).

Time frame:: 9 months
Reported as:: Count of participants · Participants

Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
Participants	Group A	Group B	Group C	Group D
SAE	10	6	7	9
IME	4	0	2	2
SLR	0	0	0	0

Adverse events

Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	1/195 (0.5%)	12/195 (6.2%)	7/195 (3.6%)
Group B	0/172 (0%)	7/172 (4.1%)	0/172 (0%)
Group C	0/170 (0%)	9/170 (5.3%)	4/170 (2.4%)
Group D	0/207 (0%)	9/207 (4.3%)	2/207 (1%)

Most frequent serious events

Showing 10 of 21

Most frequent serious events
Event	Group A	Group B	Group C	Group D
PneumoniaInfections and infestations	1/195	3/172	4/170	2/207
Amoebic dysenteryInfections and infestations	0/195	0/172	2/170	1/207
BronchiolitisInfections and infestations	2/195	0/172	0/170	2/207
Urinary Tract InfectionInfections and infestations	2/195	0/172	0/170	0/207
HydrocephalusNervous system disorders	0/195	0/172	1/170	0/207
Intracranial pressure increasedNervous system disorders	0/195	0/172	1/170	0/207
UrticariaSkin and subcutaneous tissue disorders	0/195	0/172	1/170	0/207
GastroenteritisInfections and infestations	1/195	1/172	0/170	0/207
Abscess limbInfections and infestations	0/195	1/172	0/170	0/207
Glucose-6-Phosphate Dehydrogenase DeficiencyCongenital, familial and genetic disorders	0/195	1/172	0/170	0/207

Most frequent other events

Most frequent other events
Event	Group A	Group B	Group C	Group D
BronchiolitisInfections and infestations	3/195	0/172	0/170	2/207
Febrile convulsionInfections and infestations	2/195	0/172	1/170	0/207
PharyngotonsillitisInfections and infestations	0/195	0/172	1/170	0/207
Cow milk intoleranceMetabolism and nutrition disorders	1/195	0/172	1/170	0/207
DiarrheaGastrointestinal disorders	0/195	0/172	1/170	0/207
CryptorchismCongenital, familial and genetic disorders	1/195	0/172	0/170	0/207

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group A	Group B	Group C	Group D	Total
<=18 years	200	178	178	217	773
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B	Group C	Group D	Total
Female	93	92	82	105	372
Male	107	86	96	112	401

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A	Group B	Group C	Group D	Total
Black or African American	4	1	7	3	15
Hispanic	105	108	101	132	446
Latin American	88	69	68	78	303
White / Caucasian	3	0	2	4	9

Region of Enrollment
Region of Enrollment(participants)	Group A	Group B	Group C	Group D	Total
Panama	112	82	93	100	387
Dominican Republic	88	96	85	117	386

Study locations

4 sites

Hospital Universitario Nuestra Señora de la Alta Gracia
Santo Domingo, Dominican Republic
Cevaxin Vaccination Center
David, Panama
Cevaxin Vaccination Center
La Chorrera, Panama
Cevaxin Vaccination Center
Panama city, Panama

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan ↗ · Apr 12, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Nov 2018, 12 months.

Results were first posted in Aug 2020, 1 year 9 months after primary completion.

Of 44 phase 3 interventional studies under Poliomyelitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 21. This study's 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 28, 2017
First posted: Aug 4, 2017
StartActual: Oct 23, 2017
Primary completionActual: Nov 13, 2018
CompletionActual: Nov 13, 2018
Results first posted: Aug 18, 2020
Last update: Jul 21, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03239496
Lead sponsor: Fidec Corporation
Collaborators: Bill and Melinda Gates Foundation
Responsible party: Sponsor
First posted: Aug 4, 2017
Start date: Oct 23, 2017
Primary completion: Nov 13, 2018
Completion: Nov 13, 2018
Results posted: Aug 18, 2020
Last update: Jul 21, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Poliovirus Vaccine, Inactivated

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

Study summary

Conditions studied

Browse trials for

In context

Poliomyelitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Timeline

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

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Inclusion criteria

Exclusion criteria