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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nOPV2 Candidate 1 (monovalent oral poliovirus type1) | Experimental | 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. |
|
| nOPV2 Candidate 2 (monovalent oral poliovirus type2) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nOPV2 (monovalent oral polio vaccine) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cevaxin Vaccination Center | David | Chiriquà Province | Panama | |||
| Cevaxin Vaccination Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36332645 | Derived | Wahid R, Mercer LD, De Leon T, DeAntonio R, Saez-Llorens X, Macadam A, Chumakov K, Strating J, Koel B, Konopka-Anstadt JL, Oberste MS, Burns CC, Andino R, Tritama E, Bandyopadhyay AS, Aguirre G, Ruttimann R, Gast C, Konz JO. Genetic and phenotypic stability of poliovirus shed from infants who received novel type 2 or Sabin type 2 oral poliovirus vaccines in Panama: an analysis of two clinical trials. Lancet Microbe. 2022 Dec;3(12):e912-e921. doi: 10.1016/S2666-5247(22)00254-3. Epub 2022 Nov 1. | |
| 33308427 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage I - Group A2H2 | 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). |
| FG001 | Stage II - A1H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. |
| FG002 | Stage II - A2H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. |
| FG003 | Stage I -- Group B2L1+L2[2016] | 162 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 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later. |
| FG004 | Stage I - B2H1+H2[2016] | 162 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 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. |
| FG005 | Stage II - Group B1L1+L2[2018] | 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered 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 105 CCID50 dose of candidate 1 (2018). |
| FG006 | Stage II - Group B1H1+H2[2018] | 162 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 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later |
| FG007 | Stage II - Group B2L1+L2 [2018] | 162 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 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. |
| FG008 | Stage II - Group B2H1+H2[2018] | 162 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 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage I - Group A2H2 | 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). |
| BG001 | Stage II - A1H2 [2018] |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety parameters were tabulated and analyzed descriptively in the total vaccinated (TV) population, according to the actual vaccine received. TV population is defined as all subjects who received at least one dose of study vaccine. | Posted | Number | participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage I - Group A2H2 | 50 polio vaccine primed children aged 1 to <5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2[2016]). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | General disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Rüttimann, PhD | FIDEC Corporation | +5491161188536 | rruttimann@fidec-online.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 | Dec 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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Allocation of each subject to a given group will be described in a computer-generated randomization schedule. Based on this randomization code, the study vaccine will be packaged and labeled. Medication code numbers will be preprinted on the study vaccine labels and assigned as subjects qualify for the study and are randomly assigned to dosing schedule.
|
| 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. |
| 2 months |
| 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. | 2 months |
| 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). | 2 months |
| 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. | 2 months |
| Panama City |
| Panama |
| Derived |
| 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. |
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
| BG002 | Stage II - A2H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. |
| BG003 | Stage I -- Group B2L1+L2[2016] | 162 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 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later. |
| BG004 | Stage I - B2H1+H2[2016] | 162 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 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. |
| BG005 | Stage II - Group B1L1+L2[2018] | 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered 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 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later |
| BG006 | Stage II - Group B1H1+H2[2018] | 162 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 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later |
| BG007 | Stage II - Group B2L1 +L2[2018] | 162 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 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. |
| BG008 | Stage II - Group B2H1+H2[2018] | 162 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 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later. |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stage II - A1H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. |
| OG002 | Stage II - A2H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. |
| OG003 | Stage I -- Group B2L1+L2[2016] | 162 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 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1[2016] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later. |
| OG004 | Stage I - B2H1+H2[2016] | 162 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 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. |
| OG005 | Stage II - Group B1L1+L2[2018] | 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered 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 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later |
| OG006 | Stage II - Group B1H1+H2[2018] | 162 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 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later |
| OG007 | Stage II - Group B2L1 +L2[2018] | 162 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 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. |
| OG008 | Stage II - Group B2H1+H2[2018] | 162 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 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later. |
|
|
| Primary | 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. | Per Protocol Population | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | 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. | Assessed in total vaccinated (TV) population, defined as all subjects who received at least one dose of study vaccine.Only secondary objectives included intent to compare the M5 data with the control sample which had received Sabin mOPV2 in M2 study (NCT02521974-historical control for M5). Extent of exposure: in M5 Stage II, the second dose of study vaccine were received by 47 (94%) children in Group A1H2[2018] and 50 (98%) children in Group A2H2[2018]. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | 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. | Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | 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. | Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974. | Posted | Count of Participants | Participants | 2 months |
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|
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| Secondary | 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). | Subset of subjects corresponding to 2018 Candidates cohorts. 2016 Candidate cohorts did not participate on this endpoint assessment. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974. | Posted | Median | 95% Confidence Interval | days | 2 months |
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|
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| Secondary | 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. | Per the description under the Outcome Measure Description section, these groups do not match the participants arms distribution, as these results are related to the vaccine candidates behaviour in mice, not to the participating subjects. Only secondary objectives included intent to compare the M5 data with the control sample of M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974. | Posted | Number | percentage of neurovirulence | 2 months | EES | EES |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 40 |
| 50 |
| EG001 | Stage II - A1H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days. | 0 | 49 | 1 | 49 | 36 | 49 |
| EG002 | Stage II - A2H2 [2018] | 50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days. | 0 | 51 | 3 | 51 | 44 | 51 |
| EG003 | Stage I -- Group B2L1+L2[2016] | 162 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 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later. | 0 | 155 | 7 | 155 | 82 | 155 |
| EG004 | Stage I - B2H1+H2[2016] | 162 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 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1[2016] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later. | 0 | 144 | 1 | 144 | 93 | 144 |
| EG005 | Stage II - Group B1L1+L2[2018] | 162 infants enrolled at 6 weeks of age (-7 to +14 days) administered 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 105 CCID50 dose of candidate 1 (2018). | 0 | 138 | 14 | 138 | 129 | 138 |
| EG006 | Stage II - Group B1H1+H2[2018] | 162 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 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later | 0 | 150 | 14 | 150 | 127 | 150 |
| EG007 | Stage II - Group B2L1+L2 [2018] | 162 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 105 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 [2018], 28 days later. | 0 | 135 | 9 | 135 | 118 | 135 |
| EG008 | Stage II - Group B2H1+H2[2018] | 162 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 106 CCID50 dose of candidate 2 [2018].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 [2018], 28 days later. | 1 | 151 | 15 | 151 | 126 | 151 |
| Soft Tissue Abscess (preauricular) | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Urticaria | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Second degree burn | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tonic clonic seizure | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute Diarrheal Disease | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Ventricular Septal Defect | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Withlow left hand | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Acute Gastroenteritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Congeniital Cortical Blindness | Congenital, familial and genetic disorders | MedDRA (22.0) | Systematic Assessment |
|
| Subcutaneous abscess | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Abnormal crying | General disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
|
| Fever | General disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
|
| Loss of Appetite | General disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
|
| Drowsiness | General disorders | MedDRA (22.0) | Systematic Assessment | Solicited AE |
|
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Otitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Eye Infection Bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Microcytic Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Hypochromic Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Infantile Colic | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Underweight | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Burns Second Degree | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Milk Allergy | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Transaminases increase | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Febrile Convulsion | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gross Motor Delay | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Neurodevelopmental Disorder | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| External Ear Inflammation | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Body Tinea | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Abscess Jaw | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Amoebic Dysentery | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Roseola | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Spinal Cord Abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Tinea Versicolour | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Eye Injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Psychomotor Retardation | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Motor Developmental Delay | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Food Allergy | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Blindness Cortical | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Conjunctivitis Bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Infected Bite Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| IMEs |
|
| AEs |
|