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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Larix A/S | INDUSTRY |
| Vaxtrials S.A. | OTHER |
| AJ Vaccines A/S |
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The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.
In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines are administered in the opposite (LEFT) thigh.
At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, demographics and concomitant medication are collected and a physical examination is performed and vital signs are measured. A prevaccination blood sample is taken for polio antibody determinations and the subject is randomly allocated into one of the two vaccination groups and vaccinated. A subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3. The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary, thermometer and ruler are handed out to the parents for measurements of temperature and recording of injection site reactions and solicited systemic AEs. These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved, and for recording of any other AEs as instructed by the trial staff. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is administered, immediate reactions are observed and the eDiary is returned to the partents for recordings of AEs and concomitant medications. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and concomitant medication are recorded. A blood sample from a subset of the subjects is taken for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is given, immediate reactions are observed and the eDiary is returned to the parents. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is collected and AEs and concomitant medications are recorded and a blood sample for polio antibody determination is taken.
A safety follow-up telephone call will be conducted at 12 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPV-Al SSI | Experimental | IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age. |
|
| IPV SSI | Active Comparator | IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPV-Al SSI | Biological | Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants | Change from baseline to one month after 3rd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events following vaccinations (key secondary) | After primary injections at 2, 4 and 6 months of age | |
| Subjects with seroprotection against poliovirus types 1, 2 and 3 | One months after 3rd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Subject with seroconversion against poliovirus types 1, 2 and 3 | Two months after 2nd vaccination | |
| Subjects with seroprotection against poliovirus types 1, 2 and 3 | Two months after 2nd vaccination | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Kromann | Statens Serum Institut | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cevaxin | Panama City | 0816-00383 | Panama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32273184 | Derived | Saez-Llorens X, Thierry-Carstensen B, Stoey LS, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months. Vaccine. 2020 May 6;38(21):3780-3789. doi: 10.1016/j.vaccine.2020.02.066. Epub 2020 Apr 6. |
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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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| INDUSTRY |
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| IPV SSI | Biological | Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age |
|
|
| Subjects with poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody | One months after 3rd vaccination |
| Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3 | One months after 3rd vaccination |
| Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 | From baseline and one months after 3rd vaccination |
| Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody |
| Two months after 2nd vaccination |
| Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3 | Two months after 2nd vaccination |
| Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 | From baseline and two months after 2nd vaccination |
| Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres | From baseline and one months after 3rd vaccination |
| Sensitivity analysis: sub-groups of subjects with seroprotection (titre ≥ 8) and without seroprotection (titre < 8) at baseline |
| One months after 3rd vaccination |
| 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 |