3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02347423
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: Statens Serum Institut
• Public title: 3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 824
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02347423
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Dominican Republic

Contacts

• Name: Ingrid Kromann
• Affiliation: Statens Serum Institut

Key inclusion & exclusion criteria

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



Age minimum: 42 Days
Age maximum: 49 Days
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Biological: IPV Vaccine SSI

Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI

Primary Outcome(s)

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 [Time Frame: Change from baseline to 4 weeks post 3rd vaccincation]

Secondary Outcome(s)

Type-specific reverse cumulative titer distribution curves based on pre-vaccination and 4 weeks post 3rd vaccination serum titers for each vaccine [Time Frame: 4 weeks post 3rd vaccination for each vaccine]

Type-specific seroprotection rates (titers = 1/8) [Time Frame: 4 weeks post 3rd vaccination for each vaccine]

Type-specific geometric mean titers (GMTs) [Time Frame: 4 weeks post 3rd vaccination for each vaccine]

Adverse events following the vaccinations for each vaccine [Time Frame: From inclusion to 4 weeks post 3rd vaccincation]

Secondary ID(s)

2014-003449-88

VIPV-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles, Inc.

Bill and Melinda Gates Foundation

Larix A/S