Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)

Poliomyelitis Clinical Trial

Official title:

Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448132
• Other study ID #: VIPV-07 E2
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Poliomyelitis

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