Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-7
SponsorPATH
About this trial
The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.
Eligibility criteria
Qualifiers
Healthy male or female infant 16 weeks (+ 7 days) of age, at the time of first study vaccination. 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 by the investigator.
Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
Resides in study area and parent 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).
Prior to study vaccination has received EPI vaccines as per the study EPI schedule and has received a single dose of IPV at 6 weeks (+7 days) of age.
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 (as per local guidelines) with respect to poliovirus vaccines at the time of study vaccine administration.
Member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Participants from household where a member received investigational nOPV3 vaccine will also be excluded from the study.
Low birth weight (LBW), defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth.
Premature birth (less than 37 weeks gestation).
Trial design
Treatments tested in this trial
- Novel Oral Polio Vaccine Type 1 (nOPV1)
- Novel Oral Polio Vaccine Type 2 (nOPV2)
- Placebo (Sterile Water)
Treatment groups
675 Participants
are divided into 3 treatment groupsSponsors and collaborators
PATH
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
PT Bio Farma
Collaborator
Centers for Disease Control and Prevention
Collaborator
Technical Resources International, Inc.
Collaborator
Centro de Vacunación e Investigación (Cevaxin)
Collaborator
Source ClinicalTrials.gov