Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-45
SponsorPATH
About this trial
The main objectives of this study are to :
* evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Eligibility criteria
Qualifiers
Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.
Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
Resides and plans to remain in study area and participants and parent, when applicable, understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator).
Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
Disqualifiers
Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound).
Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
Trial design
Treatments tested in this trial
- Novel oral poliomyelitis vaccine type 1 (nOPV1)
- Novel oral poliomyelitis vaccine type 2 (nOPV2)
- Novel oral poliomyelitis vaccine type 3 (nOPV3)
- Bivalent Oral Poliomyelitis Vaccine (bOPV)
Treatment groups
2,400 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
PATH
Lead sponsor
Bio Farma, Indonesia
Collaborator
Source ClinicalTrials.gov