Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)
Phase 4
Completed
- Conditions
- Poliomyelitis
- Interventions
- Biological: IPV-Al
- Registration Number
- NCT04448132
- Lead Sponsor
- AJ Vaccines A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IPV-Al AJV IPV-Al One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.
- Primary Outcome Measures
Name Time Method Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3 One month after administration of an additional dose of IPV-Al AJV Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cevaxim
🇵🇦Panama city, Panama