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COMPLETEDPHASE4

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

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

NCT04448132•AJ Vaccines A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 4 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Cevaxim

Panama City, Panama

Key Dates

Start Date

November 20, 2020

Primary Completion Date

May 3, 2021

Completion Date

May 3, 2021

Last Updated

June 22, 2021

Enrollment

163

ACTUAL participants

Conditions

Poliomyelitis

Interventions

IPV-Al

BIOLOGICAL

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RECRUITINGPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

Booster Dose of sIPV Co-administered With MMR and HepA-I.

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants