- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025750
Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age (VIPV-07)
Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 2, 4 and 6 Months of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines are administered in the opposite (LEFT) thigh.
At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, demographics and concomitant medication are collected and a physical examination is performed and vital signs are measured. A prevaccination blood sample is taken for polio antibody determinations and the subject is randomly allocated into one of the two vaccination groups and vaccinated. A subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3. The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary, thermometer and ruler are handed out to the parents for measurements of temperature and recording of injection site reactions and solicited systemic AEs. These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved, and for recording of any other AEs as instructed by the trial staff. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is administered, immediate reactions are observed and the eDiary is returned to the partents for recordings of AEs and concomitant medications. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and concomitant medication are recorded. A blood sample from a subset of the subjects is taken for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is given, immediate reactions are observed and the eDiary is returned to the parents. A contact to the parents via telephone will be made after the vaccination visit to remind the parents to fill in the eDiary and to check if they have any questions regarding how use the eDiary.
At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is collected and AEs and concomitant medications are recorded and a blood sample for polio antibody determination is taken.
A safety follow-up telephone call will be conducted at 12 months of age.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Panama City, Panama, 0816-00383
- CEVAXIN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants 2 months of age (54-75 days of age) on date of first vaccination
- Healthy assessed from medical history and physical examination
- Parent(s)/guardian(s) have been properly informed about the trial and signed informed consent form
- Parent(s)/guardian(s)granted access to the infant's trial related medical records
- Parent(s)/guardian(s)are likely to comply with trial procedures
Exclusion Criteria:
- Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
- OPV vaccination or known exposure to poliovirus (wild or vaccine-derived) in household (living together) within 3 months prior to inclusion or planned during the trial
- Low birth weight (< 2,500 g)
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
- 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, aluminium or 2-phenoxyethanol)
- 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. systemic corticosteroids, blood products and immunoglobulins) prior to inclusion or planned during the trial period
- Participating in another clinical trial
- Not suitable for inclusion in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh.
Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
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Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age
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Active Comparator: IPV SSI
IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral of the right thigh.
Each subject randomised to this group will receive a total of three primary injections - one at 2 months, 4 months and 6 months of age.
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Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants
Time Frame: Change from baseline to one month after 3rd vaccination
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Change from baseline to one month after 3rd vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
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One months after 3rd vaccination
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Adverse events following vaccinations (key secondary)
Time Frame: After primary injections at 2, 4 and 6 months of age
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After primary injections at 2, 4 and 6 months of age
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Subjects with poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody
Time Frame: One months after 3rd vaccination
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One months after 3rd vaccination
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Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
Time Frame: One months after 3rd vaccination
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One months after 3rd vaccination
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Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline and one months after 3rd vaccination
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From baseline and one months after 3rd vaccination
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject with seroconversion against poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
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Two months after 2nd vaccination
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Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
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Two months after 2nd vaccination
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Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above estimated titre of maternal antibody
Time Frame: Two months after 2nd vaccination
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Two months after 2nd vaccination
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Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3
Time Frame: Two months after 2nd vaccination
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Two months after 2nd vaccination
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Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline and two months after 2nd vaccination
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From baseline and two months after 2nd vaccination
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Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres
Time Frame: From baseline and one months after 3rd vaccination
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From baseline and one months after 3rd vaccination
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Sensitivity analysis: sub-groups of subjects with seroprotection (titre ≥ 8) and without seroprotection (titre < 8) at baseline
Time Frame: One months after 3rd vaccination
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One months after 3rd vaccination
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- VIPV-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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