Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months
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|ClinicalTrials.gov Identifier: NCT03671616|
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis||Biological: IPV-Al SSI||Phase 3|
At Visit 1 (screening, blood sample, and vaccination), the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, and concomitant medication are collected and a physical examination is performed and vital signs are measured (demographics data is captured from the VIPV-07 database). The health assessment of the subject will include measurement of height, weight, temperature, heart rate, respiratory rate (breathing) and a general physical examination (which can include skin, head, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, and the musculoskeletal system). A pre-vaccination blood sample is taken for polio antibody determinations. The subject is vaccinated with IPV-Al (and concomitant vaccine(s) according to national guidelines, if relevant) and subsequently observed for immediate adverse events 30 minutes after the vaccination. An eDiary, a thermometer and a ruler are handed out to the parent(s)/guardian(s) for measurements and recording of temperature, injection site reactions and solicited systemic adverse events (AEs). These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved. Any other AEs are recorded in the eDiary as instructed by the trial staff. A contact to the parent(s)/guardian(s) via telephone will be made after the vaccination visit to remind and check if the parent(s)/guardian(s) have any questions regarding how to fill in the eDiary.
At Visit 2 (blood sample and trial completion), 1 month after Visit 1, the eDiary is collected, adverse events and concomitant medications are recorded, a blood sample for poliovirus antibody determination is taken and the end of the trial page is completed.
In addition to the trial vaccine, the trial subjects will receive concomitant routine childhood vaccinations. The trial vaccine is administered in the anterolateral aspect of the right thigh, whereas the other injectable childhood vaccines are administered in the left thigh.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||666 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI Given as a Booster Vaccination at the Age of 15-18 Months to Infants Previously Immunised With IPV-Al SSI or IPV SSI|
|Actual Study Start Date :||May 15, 2018|
|Actual Primary Completion Date :||October 3, 2018|
|Actual Study Completion Date :||October 3, 2018|
Experimental: IPV-Al SSI
Single arm trial. All subjects will receive the IPV-Al SSI as booster vaccination
Biological: IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.
- Booster effect ratiors of GMT [ Time Frame: Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2) ]Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured before and one month after the booster vaccination
- Seroprotection rates before booster vaccination [ Time Frame: 6-9 months post-3rd vaccination ]Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 before the booster vaccination.
- Seroprotection rates after booster vaccination [ Time Frame: one month after booster vaccination ]Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 one month after the booster vaccination.
- GMT value before booster vaccination [ Time Frame: 6-9 months post-3rd vaccination ]Geometric mean antibody titres (GMTs) against poliovirus types 1, 2 and 3 before the booster vaccination.
- GMT value after booster vaccination [ Time Frame: one month after booster vaccination ]GMTs against poliovirus types 1, 2 and 3 one month after the booster vaccination.
- Number of adverse events [ Time Frame: 6-9 months post-3rd vaccination and one month after booster vaccination ]All adverse event
- Persistence (tite rates) of antibodies [ Time Frame: 6-9 months post-3rd vaccination and one month after booster vaccination ]Persistence of antibodies against poliovirus types 1, 2 and 3 in subjects previously im-munised with IPV-Al SSI or IPV SSI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671616
|Panama City, Panama, 0816-00383|
|Study Director:||Ingrid Kromann||Statens Serum Institut|