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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. |
|
| Group B | Experimental | 2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. |
|
| Group C | Experimental | 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. |
|
| Group D | Experimental | 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPV | Biological | Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | To be assessed 4 weeks after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | To be assessed 4 weeks after the second dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Nuestra Señora de la Alta Gracia | Santo Domingo | Dominican Republic | ||||
| Cevaxin Vaccination Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33284114 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - 3 Doses IPV IM | 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| FG001 | Group B - 2 Doses IPV IM | 2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| FG002 | Group C - 3 Doses f-IPV | 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| FG003 | Group D - 2 Doses f-IPV ID | 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| BG001 | Group B |
| 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 | 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. | Per Protocol Population (692 subjects) is used for this assessment. The participants flow includes the Intended to Treat population (773 subjects). | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
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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 | Group A | 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Rüttimann | FIDEC Corporation | +17863546335 | 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 | Apr 12, 2018 | Aug 1, 2020 | 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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| f-IPV | Biological | Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
|
| 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. |
| 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. | 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. | 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. | 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). | 9 months |
| David |
| Panama |
| Cevaxin Vaccination Center | La Chorrera | Panama |
| Cevaxin Vaccination Center | Panama City | Panama |
2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| BG002 | Group C | 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| BG003 | Group D | 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
| BG004 | 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 | Group D | 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) |
|
|
|
| Primary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
|
|
|
| Primary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the second dose |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the second dose |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Mean | 95% Confidence Interval | percentage of seroconversion | To be assessed 4 weeks after the last dose |
|
|
|
|
| Secondary | 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). | Total Vaccinated Population (744 subjects) is used for safety analysis. The participants flow indicate the Intended To Treat population (773 subjects). | Posted | Count of Participants | Participants | 9 months |
|
|
|
| 1 |
| 195 |
| 12 |
| 195 |
| 7 |
| 195 |
| EG001 | Group B | 2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) | 0 | 172 | 7 | 172 | 0 | 172 |
| EG002 | Group C | 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) | 0 | 170 | 9 | 170 | 4 | 170 |
| EG003 | Group D | 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks. f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID) | 0 | 207 | 9 | 207 | 2 | 207 |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Amoebic dysentery | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Pertussis | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Adrenogenital syndrome | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Glucose-6-Phosphate Dehydrogenase Deficiency | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | Non-systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Cow milk intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Febrile convulsion | Infections and infestations | Non-systematic Assessment |
|
| Cow milk intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| 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 |
| IME |
|
| SLR |
|