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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04448132
Other study ID # VIPV-07 E2
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 20, 2020
Est. completion date May 3, 2021

Study information

Verified date June 2021
Source AJ Vaccines A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date May 3, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 4 Years
Eligibility Inclusion Criteria: 1. Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials 2. Healthy, as 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 been granted access to the child´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. Previous vaccination with OPV 2. Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials 3. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion. 4. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease 5. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol) 6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling 7. 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 8. Participating in another interventional clinical trial 9. Not suitable for inclusion in the opinion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IPV-Al
adjuvanted reduced dose inactivated polio vaccine

Locations

Country Name City State
Panama Cevaxim Panama city

Sponsors (1)

Lead Sponsor Collaborator
AJ Vaccines A/S

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroprotection (titer =8) against poliovirus types 1, 2 and 3 Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples One month after administration of an additional dose of IPV-Al AJV
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