None listed
Conditions
Brief summary
This trial will assess whether inactivated polio vaccine given as an injection together with a live polio vaccine given orally is capable of inducing immunity against poliovirus in the intestinal mucosal space (so called mucosal immunity); this knowledge will be important when deciding on outbreak response strategies in cases of poliovirus outbreaks because only mucosal immunity is capable of stopping an outbreak by preventing infected individuals from excreting poliovirus in stool and infecting others
Interventions
IPV: one dose (0.5 ml) of Inactivated poliovirus vaccine administered intramuscularly; tOPV: one dose (2 drops) of trivalent oral poliovirus vaccine administered orally; bOPV: one dose (2 drops) of bivalent poliovirus vaccine administered orally; all vaccines administered on-site by study staff
All Arms: blood collection at enrollment, 30 and 60 days post enrollment; stool collection 30, 37, 44 and 51 days post enrollment
Arm 1: IPV at enrollment; tOPV 30 days post enrollment
Arm 2: IPV+bOPV a
IPV: one dose (0.5 ml) of Inactivated poliovirus vaccine administered intramuscularly; tOPV: one dose (2 drops) of trivalent oral poliovirus vaccine administered orally; bOPV: one dose (2 drops) of bivalent poliovirus vaccine administered orally; all vaccines administered on-site by study staff All Arms: blood collection at enrollment, 30 and 60 days post enrollment; stool collection 30, 37, 44 and 51 days post enrollment Arm 1: IPV at enrollment; tOPV 30 days post enrollment Arm 2: IPV+bOPV at enrollment, tOPV 30 days post enrollment Arm 3: no vaccine at enrollment, tOPV 30 days post enrollment
Sponsors
WHO
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
3 Months to 7 Months
Healthy volunteers
Yes
Inclusion criteria
Healthy infants born between June 1 and August 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arms 1 and 2. Healthy infants born between November 1 and December 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arm 3.
Exclusion criteria
Infants <3 percentile for height and weight, residence outside the catchment’s area, or families expecting to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the child ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally incapacity will not be eligible to participate.
Outcome results
None listed