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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03025750
Date of registration: 16/01/2017
Prospective Registration: Yes
Primary sponsor: Statens Serum Institut
Public title: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age VIPV-07
Scientific title: 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
Date of first enrolment: January 19, 2017
Target sample size: 800
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03025750
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Panama
Contacts
Name:     Ingrid Kromann
Address: 
Telephone:
Email:
Affiliation:  Statens Serum Institut
Key inclusion & exclusion criteria

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



Age minimum: 54 Days
Age maximum: 75 Days
Gender: All
Health Condition(s) or Problem(s) studied
Poliomyelitis
Intervention(s)
Biological: IPV SSI
Biological: IPV-Al SSI
Primary Outcome(s)
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]
Secondary Outcome(s)
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 [Time Frame: From baseline and one months after 3rd vaccination]
Adverse events following vaccinations (key secondary) [Time Frame: After primary injections at 2, 4 and 6 months of age]
Subjects with seroprotection against poliovirus types 1, 2 and 3 [Time Frame: One months after 3rd vaccination]
Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3 [Time Frame: One months after 3rd vaccination]
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]
Secondary ID(s)
VIPV-07
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Vaxtrials S.A.
AJ Vaccines A/S
Bill and Melinda Gates Foundation
Larix A/S
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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