Proposals for Post-Market Randomized Childhood Vaccine Trials with Ethical Designs

Abstract While we know that vaccines can both save lives and cause harm, there are many things about vaccines that we do not know. What is the optimal timing and order of different vaccines? To what extent do vaccines have non-specific effects on other infectious diseases than the targeted one? Are there any harms from aluminum adjuvants? May there be adverse outcomes due to cumulative negative effects from different vaccines in the vaccine schedule even if individual vaccines are fine? The gold standard of medical research is the double-blind placebo controlled randomized trial, but there has been few of those for vaccines. We propose a set of such trials for childhood vaccines. By using factorial trial designs, and by linking trial data to electronic health records, one can answer multiple questions about multiple vaccines within the framework of two large, randomized trials, one for infants and toddlers ages 0–5 years, and another for older children ages 9–16 years.