Poliomyelitis Clinical Trial
Official title:
Immunogenicity and Safety of 3 Adjuvated Reduced Dose Inactivated Polio Vaccines (IPV-Al SSI) and Non-adjuvated Full Dose IPV SSI, Given as Primary Vaccinations to Infants at 6, 10 and 14 Weeks of Age
Verified date | November 2018 |
Source | Statens Serum Institut |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The background of the present clinical trial is the overall aim of the World Health
Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan,
inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price,
needs to be available in low resource third world countries. The intention of the present
phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the
target population and do not decrease the immunogenicity clinically significantly compared to
full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines
according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of
age.
A total of 824 healthy infants will be included in the trial.
Status | Completed |
Enrollment | 824 |
Est. completion date | September 26, 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 42 Days to 49 Days |
Eligibility |
Inclusion Criteria: 1. Infants of 6 weeks of age (+7 days) on date of first vaccination 2. Healthy assessed from medical history and physical examination 3. One parent/guardian has been properly informed about the trial and has signed the informed consent form 4. One parent/guardian grants access to the infant's trial related medical records 5. One parent/guardian is likely to comply with trial procedures Exclusion Criteria: 1. Vaccinated with poliovirus vaccine (OPV or IPV), other than the trial vaccines, prior to inclusion or planned during the trial (e.g. on national polio immunisation days) 2. OPV vaccination or known exposure to poliovirus in household (living together) within 3 month prior to inclusion or planned during the trial 3. Has a sibling who is =5 years of age, and for whom OPV vaccination is planned during the trial 4. Low birth weight (< 2,500 g) 5. Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency 6. Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) 7. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde) 8. Acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination 9. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling 10. 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 11. Participating in another clinical trial 12. Not suitable for inclusion in the opinion of the investigator |
Country | Name | City | State |
---|---|---|---|
Dominican Republic | Hospital Maternidad Nuestra de la Altagracia | Santo Domingo |
Lead Sponsor | Collaborator |
---|---|
Statens Serum Institut | Bill and Melinda Gates Foundation, Larix A/S, Quintiles, Inc. |
Dominican Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | For each of the 3 poliovirus types 1, 2 and 3, for the IPV-Al and IPV Vaccine SSI vaccines to evaluate: Type specific seroconversion rates based on baseline and 4 weeks post 3rd vaccincation | Change from baseline to 4 weeks post 3rd vaccincation | ||
Secondary | Type-specific geometric mean titers (GMTs) | 4 weeks post 3rd vaccination for each vaccine | ||
Secondary | Type-specific seroprotection rates (titers = 1/8) | 4 weeks post 3rd vaccination for each vaccine | ||
Secondary | Type-specific reverse cumulative titer distribution curves based on pre-vaccination and 4 weeks post 3rd vaccination serum titers for each vaccine | 4 weeks post 3rd vaccination for each vaccine | ||
Secondary | Adverse events following the vaccinations for each vaccine | From inclusion to 4 weeks post 3rd vaccincation |
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