Clinical trial
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), Bivalent Oral Poliovirus Vaccine (bOPV) and Inactivated Poliovirus Vaccine (IPV) Administered With Different Sequential or Combination Schedules
Name
PR-23036
Description
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:
1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
2. Separation of bOPV and nOPV2 with an interval of 4 weeks.
Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-06-01
Trial end
2024-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
polio vaccines: nOPV2, bOPV, IPV
Co-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules.
Arms:
Arm A : 3 doses of nOPV2 and bOPV with IPV, Arm B : 2 doses of nOPV2 and bOPV with IPV, Arm C: Single dose of bOPV, nOPV2, IPV, Arm D: Single dose nOPV2, IPV
Size
880
Primary endpoint
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.
Serology: 6 &18 weeks
Eligibility criteria
Inclusion Criteria:
1. Healthy infants 6 weeks of age
2. Parents that consent for participation in the full length of the study.
3. Parents that can understand and comply with planned study procedures.
Exclusion Criteria:
1. Parents and infants are unable to participate in the full length of the study
2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
3. A diagnosis or suspicion of bleeding disorder
4. Acute diarrhoea, infection, or illness at the time of enrolment
5. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
6. Evidence of a chronic medical condition
7. Receipt of any polio vaccine (OPV or IPV) before enrolment
8. Known allergy/sensitivity or reaction to polio vaccine, or its contents.
9. Infants from multiple births.
10. Infants from premature births (\<37 weeks of gestation).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is an open-label, controlled, inequality, 4 arm randomized clinical trial assessing immunogenicity of several poliovirus vaccines and doses', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 880, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
1 product
1 indication
Product
Polio VaccinesIndication
Polio