Status:
COMPLETED
Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)
Lead Sponsor:
AJ Vaccines A/S
Conditions:
Poliomyelitis
Eligibility:
All Genders
4-4 years
Phase:
PHASE4
Brief Summary
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodie...
Eligibility Criteria
Inclusion
- Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
- Healthy, as assessed from medical history and physical examination
- Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
- Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
- Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures
Exclusion
- Previous vaccination with OPV
- Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
- Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
- Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period
- Participating in another interventional clinical trial
- Not suitable for inclusion in the opinion of the investigator
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT04448132
Start Date
November 20 2020
End Date
May 3 2021
Last Update
June 22 2021
Active Locations (1)
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1
Cevaxim
Panama City, Panama