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The problem
Intervention: Inactivated rotavirus vaccine (IRV) at three different antigen doses (80, 160, or 320 ELISA Units) administered in either 2 or 3-dose schedules
Who it was tested with: 288 healthy children aged 2-71 months without prior rotavirus vaccination or HIV infection, stratified by age (7-71 months and 2-6 months).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"This double-blind, randomised, placebo-controlled, dose-escalation phase I trial evaluated the safety and immunogenicity of IRV in 288 healthy children aged 2-71 months" with "primary endpoints include[ing] adverse reactions/events within 30 min post-dose, adverse reactions/events during days 0-7 and 8-28/30 post-dose, and serious adverse events (SAEs) 6 months after the full course." The randomized controlled design with placebo comparison and predefined safety and immunogenicity endpoints provides experimental-level evidence for vaccine tolerability and immune response.
Phase I trial focuses on safety and immunogenicity only, not clinical efficacy. Results from a limited sample may not generalize to all populations. Long-term protection and durability of immune response not assessed.
Across countries and designs
1 study · 0 countries
Classified by the Hub's AI
Not yet reviewed by a person. Model output is not AICS's view until reviewed.
claude-haiku-4-5-20251001 · synth-v1
