Table 1.
Allocation | Follow up time following enrolment |
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Week 0 | Week 1 | Week 4 | Week 24 | Week 28 | |
Group A (Single dose) |
Strata 1 and 3: Vi-DT Strata 2: Vi-DT plus TRIMOVAX®† All Strata: Immediate safety |
Safety assessment | Safety and immunogenicity assessment |
All Strata: FluQuadri™ All Strata: Immediate safety |
Safety and immunogenicity |
Group B (Two dose) |
All Strata: Vi-DT All Strata: Immediate safety a |
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Group C (Comparator) |
Strata 1 and 3: Placebo‡ Strata 2: TRIMOVAX®† All Strata: Immediate safety |
All Strata: FluQuadri™ and Immediate safety |
Age Stratum 1 (6 to <9months); Age Stratum 2 (9 to 12 months); Age Stratum 3 (13-23 months).
TRIMOVAX® – attenuated measles, mumps and rubella (MMR) vaccine was given to children between the ages of 9-12 months.
Placebo for Age Strata 1 and 3 at enrolment was normal saline injection.