She also stated that no efficacy trials for children under 15 have been performed.
There were nine efficacy trials with at least five different vaccines, involving over 330,000 children.
In this paper, we investigated how efficacy trials of vaccines and preventive treatment could be conducted with low challenge doses in animal models.
The trials would test only for toxicity; efficacy trials would follow if the drug seems safe in humans.
Small-scale efficacy trials were carried out in the 1970s and 1980s, and attention grew in the 1990s following a meta-analysis.
It is the first vaccine in the United States to reach large-scale efficacy trials, known as Phase 3 studies.
No efficacy trials for children under 15 have been performed.
"What is it going to do to the efficacy trials?"
Adequate safety and efficacy trials must be carried out.
A 56-week safety and efficacy trial, published in The Lancet.