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CompletedNCT03554798Updated Jan 19, 2024Results posted

A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

A Phase 2 interventional study of nOPV2 (monovalent oral polio vaccine) in Poliomyelitis, sponsored by Fidec Corporation. Completed at 2 sites in Panama. Open to participants aged 6 Weeks to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Fidec Corporation · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
1,025
Allocation
Randomized
Ages
6 Weeks to 5 Years
Sex
All
01

Study summary

This will be a single center, age de-escalation, partly-blinded, randomized study.

The trial will be performed with the participation of 100 healthy children age 1-5 years who have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old infants to groups will be performed in a randomized manner. Following completion and Data Safety Monitoring Board (DSMB) review of follow-up for general safety data (Serioius Adverse Events -SAEs-, Important Medical Events -IMEs- and severe adverse events -AEs), a DSMB recommendation to proceed will result in randomization of the final cohort of infants. Allocation of 1 to 5 year-old children to groups will be performed in a randomized manner.

The DSMB will establish and continuously assess stopping rules for safety.

02

Conditions studied

  • Poliomyelitis

Browse trials for

03

In context

Poliomyelitis

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

This study's enrollment of 1,025 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.

04

Who can participate

Ages eligible
6 Weeks to 5 Years
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

  1. For Cohort A children enrolled at 1 to 5 years of age who have previously been fully vaccinated according to MoH recommendations with OPV and/or IPV.
  2. For Cohort B infants enrolled at 6 weeks of age (-1, + 2 weeks) with birth weight >2,500 gm. To be eligible to continue into the experimental phase of the study infants must be vaccinated with 3 doses of bOPV and one dose of IPV prior to administration of the study vaccine at 18-22 weeks of age to take into account the visit windows for enrollment (age 6 weeks, -1 or + 2 weeks) and subsequent OPV vaccination windows (± 1 week). The last polio vaccine must have been administered at least 4 weeks prior to the first dose of study vaccine. Subjects in Cohort B who do not complete the three routine vaccination visits will be replaced in the study, and their parents/guardians will be encouraged to complete the primary vaccinations series.
  3. Healthy children without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of or immunotherapies that preclude the subject to be in the study as established by the medical history and physical examination.
  4. Written obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion criteria

Exclusion Criteria:

  1. For all participants the presence of anyone under 10 years of age in the subject's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration. For household members younger than 18 months age appropriate vaccination is at least three (3) doses of IPV. For household members between 18 months and 10 years "age appropriate" vaccination is at least three (3) doses of IPV or tOPV plus one (1) booster dose of any antipolio vaccine.
  2. For all participants having a member of the subject's household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
  3. For all participants having a member of the subject's household (living in the same house or apartment unit) who has received OPV in the previous 3 months before study vaccine administration.
  4. For Cohort A: receipt of polio vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented). Any other vaccine 4 weeks before study entry.
  5. For Cohort A: any participating children attending day care or pre-school during their participation in the study until one month after their last nOPV2 administration.
  6. For Cohort B: any receipt of polio vaccines prior to administration of the study vaccine other than 3 doses of bOPV and 1 dose of IPV.
  7. Any confirmed or suspected or known immunodeficient condition including (HIV) infection in the potential participant or any member of the subject's household.
  8. Family history of congenital or hereditary immunodeficiency.
  9. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
  10. Known allergy to any component of the study vaccines or to any antibiotics, that share molecular composition with the nOPV2 vaccines.
  11. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV).
  12. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  13. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
  14. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Terms in these criteria, in plain language(5)

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,025 participants (actual)

Study arms

  • Experimental
    nOPV2 Candidate 1 (monovalent oral poliovirus type1)

    Cohort A: IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1. Cohort B: 6 weeks Infants vaccinated with 3 doses of bOPV and 1 dose of IPV, followed with 1 dose of candidate 1.

    Biological: nOPV2 (monovalent oral polio vaccine)

  • Experimental
    nOPV2 Candidate 2 (monovalent oral poliovirus type2)

    Cohort A: IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 2. Cohort B: Infants vaccinated with 3 doses of bOPV and 1 dose of IPV, followed with 1 dose of candidate 2.

    Biological: nOPV2 (monovalent oral polio vaccine)

Interventions

  • BiologicalnOPV2 (monovalent oral polio vaccine)

    Cohort A: 150 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days. Cohort B: 972 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2.

06

What researchers measure

Primary outcomes

  1. Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence

    Number of subjects experiencing Serious Adverse Reactions (SAR), severe AR and IMR, i.e. SAEs, severe AEs (grade 3), or IMEs considered consistent with a causal association with study vaccines as of the informed consent signature date and throughout the study period in all groups.

    Time frame: 6 months

  2. Single Dose Seroprotection Rate

    Seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following a single 105 or 106 CCID50 dose of nOPV2 candidates in all groups. Seroprotection rate is defined as the percentage of subjects with type 2-specific antibody titers ≥ 1:8 per group.

    Time frame: 2 months

Secondary outcomes

  1. Any Other SAEs, AEs and IMEs Incidence

    Number of participants experiencing any other SAE, any solicited AE, any unsolicited AEs and any IME as well as any clinical laboratory deviation considered consistent with causal association to study vaccine (primary objective) following one or two doses of either nOPV2 candidates.

    Time frame: 6 months

  2. Seroconversion Rates Comparison

    Seroconversion rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroconversion is defined as a change from seronegative to seropositive, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline (Day 0) titers corrected for maternal antibodies titers where applicable/age-appropriate.

    Time frame: 2 months

  3. Seroprotection Rates Comparison

    Seroprotection rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroprotection rate is defined as the percentage of subjects with type 2-specific neutralizing antibody titers ≥ 1:8 per group.

    Time frame: 2 months

  4. Viral Shedding

    Level of viral shedding in stool at fixed time points following administration of one or two doses of both nOPV2 candidates at both 105 and 106 CCID50 dose levels in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this shedding to a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study designed to serve as a control for the current study. This is determined by measuring the median number of days taken to get stool cultures negative for poliovirus presence (TTCN stands for median time to culture negative). Kaplan-Meier methods were used to describe the time to cessation of shedding for any shedding (PCR detection).

    Time frame: 2 months

  5. Neurovirulence

    Potential for neurovirulence of virus isolated from a subset of stool samples of infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and following a single dose of both nOPV2 candidates at the 106 CCID50 dose level, as measured in an animal model, and compare this with a control sample (M2 study). For each of the children / infants receiving a 106 CCID50 dose of the 2018 cohorts as well as all participants in study M2, an exploratory endpoint sample (EES) of poliovirus shed in stools following the first dose was identified, if possible, with which to perform a modified neurovirulence test in a transgenic mouse model. Data from each sample tested was summarized by group per vaccine candidate. The proportion of mice paralyzed and the odds ratio of paralysis from the single-dose assay were the primary means of comparison of neurovirulence of shed virus between each candidate and the Sabin mOPV2 control samples.

    Time frame: 2 months

07

Results

Posted Mar 23, 2022

Participant flow

Participant flow — Overall Study
MilestoneStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]
Started505051156144138150135151
Completed454748154141137149133149
Not completed533231122

Outcome measures

PrimarySerious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence

Number of subjects experiencing Serious Adverse Reactions (SAR), severe AR and IMR, i.e. SAEs, severe AEs (grade 3), or IMEs considered consistent with a causal association with study vaccines as of the informed consent signature date and throughout the study period in all groups.

Time frame:
6 months
Reported as:
Number · participants
Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence
participantsStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1 +L2[2018]Stage II - Group B2H1+H2[2018]
Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence010561111
PrimarySingle Dose Seroprotection Rate

Seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following a single 105 or 106 CCID50 dose of nOPV2 candidates in all groups. Seroprotection rate is defined as the percentage of subjects with type 2-specific antibody titers ≥ 1:8 per group.

Time frame:
2 months
Reported as:
Count of participants · Participants
Single Dose Seroprotection Rate
ParticipantsStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]
Single Dose Seroprotection Rate453747125132122134115138
SecondaryAny Other SAEs, AEs and IMEs Incidence

Number of participants experiencing any other SAE, any solicited AE, any unsolicited AEs and any IME as well as any clinical laboratory deviation considered consistent with causal association to study vaccine (primary objective) following one or two doses of either nOPV2 candidates.

Time frame:
6 months
Reported as:
Number · participants
Any Other SAEs, AEs and IMEs Incidence
participantsStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]M2 Group 2+3M2 Children
SAEs01220913501
IMEs10000000010
AEs3236443029343736333628
SecondarySeroconversion Rates Comparison

Seroconversion rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroconversion is defined as a change from seronegative to seropositive, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline (Day 0) titers corrected for maternal antibodies titers where applicable/age-appropriate.

Time frame:
2 months
Reported as:
Count of participants · Participants
Seroconversion Rates Comparison
ParticipantsStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]M2 Group 2+3M2 Children
Seroconversion Rates Comparison181722404344473848386
SecondarySeroprotection Rates Comparison

Seroprotection rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroprotection rate is defined as the percentage of subjects with type 2-specific neutralizing antibody titers ≥ 1:8 per group.

Time frame:
2 months
Reported as:
Count of participants · Participants
Seroprotection Rates Comparison
ParticipantsStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]M2 Group 2+3M2 Children
Seroprotection Rates Comparison4439464446454843483946
SecondaryViral Shedding

Level of viral shedding in stool at fixed time points following administration of one or two doses of both nOPV2 candidates at both 105 and 106 CCID50 dose levels in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this shedding to a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study designed to serve as a control for the current study. This is determined by measuring the median number of days taken to get stool cultures negative for poliovirus presence (TTCN stands for median time to culture negative). Kaplan-Meier methods were used to describe the time to cessation of shedding for any shedding (PCR detection).

Time frame:
2 months
Reported as:
Median · days
Viral Shedding
daysStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]M2 Group 2+3M2 Children
Viral Shedding—5 (4 to 5)3 (2.5 to 5)——6 (5 to 7)6 (5 to 7)6 (5 to 7)5 (4 to 6)6 (5 to 7)6.5 (5 to 9)
SecondaryNeurovirulence

Potential for neurovirulence of virus isolated from a subset of stool samples of infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and following a single dose of both nOPV2 candidates at the 106 CCID50 dose level, as measured in an animal model, and compare this with a control sample (M2 study). For each of the children / infants receiving a 106 CCID50 dose of the 2018 cohorts as well as all participants in study M2, an exploratory endpoint sample (EES) of poliovirus shed in stools following the first dose was identified, if possible, with which to perform a modified neurovirulence test in a transgenic mouse model. Data from each sample tested was summarized by group per vaccine candidate. The proportion of mice paralyzed and the odds ratio of paralysis from the single-dose assay were the primary means of comparison of neurovirulence of shed virus between each candidate and the Sabin mOPV2 control samples.

Time frame:
2 months
Reported as:
Number · percentage of neurovirulence
Neurovirulence
percentage of neurovirulencemOPV2nOPV2 C1 2018nOPV2 C2 2018
Neurovirulence90030

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stage I - Group A2H20/50 (0%)0/50 (0%)40/50 (80%)
Stage II - A1H2 [2018]0/49 (0%)1/49 (2%)36/49 (73.5%)
Stage II - A2H2 [2018]0/51 (0%)3/51 (5.9%)44/51 (86.3%)
Stage I -- Group B2L1+L2[2016]0/155 (0%)7/155 (4.5%)82/155 (52.9%)
Stage I - B2H1+H2[2016]0/144 (0%)1/144 (0.7%)93/144 (64.6%)
Stage II - Group B1L1+L2[2018]0/138 (0%)14/138 (10.1%)129/138 (93.5%)
Stage II - Group B1H1+H2[2018]0/150 (0%)14/150 (9.3%)127/150 (84.7%)
Stage II - Group B2L1+L2 [2018]0/135 (0%)9/135 (6.7%)118/135 (87.4%)
Stage II - Group B2H1+H2[2018]1/151 (0.7%)15/151 (9.9%)126/151 (83.4%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]
BronchiolitisRespiratory, thoracic and mediastinal disorders0/501/491/512/1550/1449/1388/1502/13510/151
PneumoniaRespiratory, thoracic and mediastinal disorders0/500/490/514/1551/1444/1386/1504/1353/151
Soft Tissue Abscess (preauricular)Ear and labyrinth disorders0/500/491/510/1550/1440/1380/1500/1350/151
UrticariaGeneral disorders0/500/491/510/1550/1440/1380/1500/1350/151
Acute GastroenteritisGastrointestinal disorders0/500/490/510/1550/1440/1381/1502/1350/151
Urinary Tract InfectionRenal and urinary disorders0/500/490/510/1550/1440/1380/1501/1351/151
Congeniital Cortical BlindnessCongenital, familial and genetic disorders0/500/490/510/1550/1440/1380/1501/1350/151
Tonic clonic seizureNervous system disorders0/500/490/510/1550/1441/1380/1500/1350/151
Acute Diarrheal DiseaseGastrointestinal disorders0/500/490/510/1550/1441/1380/1500/1350/151
Ventricular Septal DefectCardiac disorders0/500/490/510/1550/1441/1380/1500/1350/151
Most frequent other events
Showing 10 of 100
Most frequent other events
EventStage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1+L2 [2018]Stage II - Group B2H1+H2[2018]
NasopharyngitisInfections and infestations18/502/494/5152/15565/14462/13871/15069/13578/151
InfluenzaInfections and infestations9/5023/4925/511/1551/1440/1380/1500/1350/151
Loss of AppetiteGeneral disorders16/5013/4913/5122/15513/14411/13815/15014/13519/151
FeverGeneral disorders6/5012/4915/5114/15512/14415/13812/15020/13518/151
Abnormal cryingGeneral disorders2/507/495/5135/15524/14426/13824/15021/13525/151
DiarrhoeaGastrointestinal disorders11/509/494/519/1557/1442/1389/1501/1354/151
IrritabilityGeneral disorders2/503/495/5130/15518/14423/13827/15025/13525/151
DrowsinessGeneral disorders2/509/495/518/1559/1446/13811/15010/13515/151
PharyngotonsillitisInfections and infestations4/507/498/511/1551/1440/1381/1500/1351/151
VomitingGastrointestinal disorders6/505/496/5120/15521/14419/13822/15020/13519/151

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Stage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1 +L2[2018]Stage II - Group B2H1+H2[2018]Total
<=18 years5049511561441381501351511024
Between 18 and 65 years0000000000
>=65 years0000000000
Sex: Female, Male
Sex: Female, Male(Participants)Stage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1 +L2[2018]Stage II - Group B2H1+H2[2018]Total
Female172429666569717473488
Male332522907969796178536
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Stage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1 +L2[2018]Stage II - Group B2H1+H2[2018]Total
Mixed race244951151141135147132151981
Other260000000026
Black or African American0003001105
Central American Indian0001232109
Hispanic0001000001
White0000100102
Region of Enrollment
Region of Enrollment(participants)Stage I - Group A2H2Stage II - A1H2 [2018]Stage II - A2H2 [2018]Stage I -- Group B2L1+L2[2016]Stage I - B2H1+H2[2016]Stage II - Group B1L1+L2[2018]Stage II - Group B1H1+H2[2018]Stage II - Group B2L1 +L2[2018]Stage II - Group B2H1+H2[2018]Total
Panama5049511561441381501351511024
08

Study locations

2 sites
  • Cevaxin Vaccination Center
    David, Chiriquí, Panama
  • Cevaxin Vaccination Center
    Panamá, Panama
09

References and documents

Publications

  • Saez-Llorens X, Bandyopadhyay AS, Gast C, Leon T, DeAntonio R, Jimeno J, Caballero MI, Aguirre G, Oberste MS, Weldon WC, Konopka-Anstadt JL, Modlin J, Bachtiar NS, Fix A, Konz J, Clemens R, Costa Clemens SA, Ruttimann R. Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials. Lancet. 2021 Jan 2;397(10268):27-38. doi: 10.1016/S0140-6736(20)32540-X. Epub 2020 Dec 9. PubMed 33308427 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03554798
Lead sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Jun 13, 2018
Start date
Dec 4, 2018
Primary completion
Feb 19, 2020
Completion
Feb 19, 2020
Results posted
Mar 23, 2022
Last update
Jan 19, 2024

Oversight

Data monitoring committee
Yes
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 Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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