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Trial record 2 of 280 for:    Panama

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
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Larix A/S
Vaxtrials S.A.
AJ Vaccines
Information provided by (Responsible Party):
Statens Serum Institut

Brief Summary:
This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV-Al SSI Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 666 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of adverse events [ Time Frame: 6-9 months post-3rd vaccination and one month after booster vaccination ]
    All adverse event

  6. 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



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Ages Eligible for Study:   15 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infants having completed the VIPV-07 trial
  2. Healthy assessed from medical history and physical examination
  3. Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
  4. Parent(s)/guardian(s), according to the local legal requirements, have granted access to the infant's trial related medical records
  5. Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures

Exclusion Criteria:

  1. Previously vaccinated with OPV
  2. Previously vaccinated with IPV outside the VIPV-07 trial
  3. Known or suspected immunodeficiency (e.g. leukaemia or lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criterion
  4. Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine)
  5. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
  6. Previous Yellow Fever vaccination
  7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
  8. In treatment with systemic corticosteroids given p.o., i.v., i.m. ≤ 1 month prior to inclusion or during the trial. Subjects administered corticosteroid topically or by asthma inhalators are eligible for inclusion
  9. Treatment with a product, which is likely to modify the immune response (e.g blood products and immunoglobulins) ≤ 3 months prior to inclusion or planned during the trial period
  10. Participating in another interventional clinical trial
  11. Not suitable for inclusion in the opinion of the investigator

Information from the National Library of Medicine

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


Locations
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Panama
Cevaxin
Panama City, Panama, 0816-00383
Sponsors and Collaborators
Statens Serum Institut
Bill and Melinda Gates Foundation
Larix A/S
Vaxtrials S.A.
AJ Vaccines
Investigators
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Study Director: Ingrid Kromann Statens Serum Institut

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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT03671616     History of Changes
Other Study ID Numbers: VIPV-07 E1
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: EudraCT
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs