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

NCT04448132 | Completed Phase 4

• 1 other identifier: VIPV-07 E2
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IPV-Al AJV

EXPERIMENTAL

One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.

Biological: IPV-Al

Interventions

IPV-Al BIOLOGICAL

adjuvanted reduced dose inactivated polio vaccine

Also known as: Picovax®, IPV-Al AJV

IPV-Al AJV

Eligibility Criteria

• Age: 4 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Previous vaccination with OPV
• Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
• 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
• Participating in another interventional clinical trial

Sponsors & Collaborators

• AJ Vaccines A/S: lead

Study Sites (1)

Cevaxim

Panama City, Panama

Location

Related Publications (1)

• Saez-Llorens X, Chan M, DeAntonio R, Petersen T, Olesen C, Jensen JS, Sorensen C, Ekstrand LM, Czort MK, Kristensen HH, Thulstrup N, Christoffersen DB. Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax(R), a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine. Vaccine. 2022 Sep 22;40(40):5835-5841. doi: 10.1016/j.vaccine.2022.06.084. Epub 2022 Sep 3.

  PMID: 36064670 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: November 20, 2020
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)