A Phase 4 interventional study of Oral Polio Vaccine in Poliomyelitis, sponsored by Fidec Corporation. Completed. Open to participants aged 5 Weeks to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Fidec Corporation · Phase 4, Interventional, and Prevention
The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.
This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart (Group 2)
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 154 is below the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →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.
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.
Age:
Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group 2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.
Exclusion Criteria:
Previous Vaccinations:
Group 1: Previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks.
Group 2: Any vaccination against poliovirus
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment. The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
Biological: Oral Polio Vaccine
Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment. The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
SAEs and AEs G3
Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.
Time frame: 6 months
Seroprotection Rate
Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).
Time frame: 3 months
Neutralizing Antibodies 1
Median titers of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).
Time frame: 3 months
Seroconversion Rate
Seroconversion rate of type-specific neutralizing antibodies at Day 28 for Group 1, and at Day 84 for Group 2.
Time frame: 3 months
Neutralizing Antibodies 2
Geometric mean antibody titers (GMT) of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).
Time frame: 3 months
Seroprotection Rates
Seroprotection rates of type-specific neutralizing antibodies at Days 0 and 28 in Group 1 and at Day 0 in Group 2.
Time frame: 4 weeks
| Milestone | Group1 | Group 2 |
|---|---|---|
| Started | 50 | 104 |
| Completed | 50 | 104 |
| Not completed | 0 | 0 |
Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.
| Participants | Group1 | Group 2 |
|---|---|---|
| SAEs and AEs G3 | 0 | 0 |
Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).
| percentage of participants | Group 2 |
|---|---|
| Serotype 1 | 93.3 (86.6 to 97.3) |
| Serotype 2 | 100 (96.5 to 100) |
| Serotype 3 | 96.2 (90.4 to 98.9) |
Median titers of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).
| log^2 | Group1 | Group 2 |
|---|---|---|
| Serotype 1 | 10.50 (9.17 to 10.50) | 10.50 (9.17 to 10.50) |
| Serotype 2 | 9.83 (9.50 to 10.50) | 10.17 (9.83 to 10.17) |
| Serotype 3 | 8.50 (7.83 to 9.50) | 8.83 (8.50 to 9.50) |
Seroconversion rate of type-specific neutralizing antibodies at Day 28 for Group 1, and at Day 84 for Group 2.
| percentage of participants | Group1 | Group 2 |
|---|---|---|
| Serotype 1 | 32.7 (19.9 to 47.5) | 88.5 (80.7 to 93.9) |
| Serotype 2 | 36.7 (23.4 to 51.7) | 98.1 (93.2 to 99.8) |
| Serotype 3 | 46.9 (32.5 to 61.7) | 96.2 (90.4 to 98.9) |
Geometric mean antibody titers (GMT) of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).
| GMTs | Group 1 | Group 2 |
|---|---|---|
| Serotype 1 | 445.5 (272.7 to 710.6) | 650.8 (473.7 to 870.6) |
| Serotype 2 | 681.2 (511.1 to 882.9) | 712.2 (594.4 to 840.3) |
| Serotype 3 | 306.3 (201.7 to 452.0) | 352.1 (263.9 to 462.9) |
Seroprotection rates of type-specific neutralizing antibodies at Days 0 and 28 in Group 1 and at Day 0 in Group 2.
| percentage of participants | Group 1 | Group 2 |
|---|---|---|
| Serotype 1 | 93.0 (83.1 to 98.7) | 60.6 (50.5 to 70.0) |
| Serotype 2 | 100 (92.7 to 100) | 60.6 (50.5 to 70.0) |
| Serotype 3 | 98 (89.1 to 99.9) | 26 (17.9 to 35.5) |
Collected over 3.5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group1 | 0/50 (0%) | 0/50 (0%) | 8/50 (16%) |
| Group 2 | 0/104 (0%) | 0/104 (0%) | 52/104 (50%) |
| Event | Group1 | Group 2 |
|---|---|---|
| NasopharyngitisInfections and infestations | 0/50 | 9/104 |
| FeverGeneral disorders | 3/50 | 8/104 |
| VomitingGastrointestinal disorders | 1/50 | 8/104 |
| IrritabilityGeneral disorders | 0/50 | 6/104 |
| Abnormal cryingGeneral disorders | 1/50 | 5/104 |
| Appetite lostGastrointestinal disorders | 1/50 | 3/104 |
| DrowsinessGeneral disorders | 0/50 | 3/104 |
| Ear infectionInfections and infestations | 1/50 | 1/104 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/50 | 1/104 |
| DiarrheaGastrointestinal disorders | 0/50 | 2/104 |
| Age, Categorical(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| <=18 years | 50 | 104 | 154 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 23 | 56 | 79 |
| Male | 27 | 48 | 75 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 50 | 104 | 154 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Dominican Republic | 50 | 104 | 154 |
No study locations are listed for this record.
The record gives a start of Nov 2015, a primary completion of Jul 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2020, 4 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oral Polio Vaccine
Fidec Corporation