- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032419
Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months (VIPV-06)
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 6, 10, 14 Weeks and 9 Months of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:
Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.
2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.
Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood sample is taken for polio antibody measurements, contraindications are reviewed, the 4th vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded. The end of trial form is completed.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Manila, Philippines
- 5 sites in Philippines
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
- Healthy assessed from medical history and physical examination
- Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
- Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
- Parent(s)/guardian(s) granting access to the infant's trial related medical records
- Parent(s)/guardian(s) likely to comply with the 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. blood products and immunoglobulins) prior to inclusion or planned during the trial
- 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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh.
Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
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3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 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 aspect of the right thigh.
Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
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3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 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
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 |
---|---|
Adverse event 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 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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Subjects with seroprotection against poliovirus types 1, 2 and 3
Time Frame: Before and one month after the 4th vaccination
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Before and one month after the 4th vaccination
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Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the 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 medians 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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Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Time Frame: Before and one month after the 4th vaccination
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Before and one month after the 4th vaccination
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Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination
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From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres
Time Frame: From baseline to one month after 3rd vaccination
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From baseline to one month after 3rd vaccination
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3
Time Frame: One month after 3rd vaccinations
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One month after 3rd vaccinations
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3
Time Frame: Before and one month after 4th vaccination
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Before and one month after 4th vaccination
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - post-vaccination titre ≥ 4-fold above maternal titre against poliovirus types 1, 2 and 3
Time Frame: One month after 3th vaccination
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One month after 3th vaccination
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3
Time Frame: One month after 3th vaccination
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One month after 3th vaccination
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3
Time Frame: Before and one month after 4th vaccination
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Before and one month after 4th vaccination
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Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time Frame: From baseline to one month after 4th vaccination
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From baseline to one month after 4th 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-06
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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