A plot of the number of daily febrile seizure episodes in a time period starting 30 days before and ending 30 days after day of vaccination suggests an excess of cases the first few days after vaccination (Fig. 2, top panel).
To monitor fever, subjects were also provided with digital thermometers to measure and record their oral temperature each evening for 21 days starting on the day of vaccination.
We considered pregnant women to be exposed to the vaccine from the day of vaccination.
T-cell responses to the influenza antigens NP and M1 were measured in all volunteers at screening and again on day of vaccination and 21 days later in the vaccinees and in all volunteers on the day prior to challenge, as well as 8 occasions after influenza challenge.
On the day of vaccination and again 30 days after each vaccination, subjects were questioned by the investigator about AEs, and a physical examination was performed to evaluate for any dengue-like signs, including rash, hemorrhage (skin, conjunctival, or mucosal), conjunctival injection, hepatomegaly, splenomegaly, or lymphadenopathy.
GM-CSF at 125 μL was administered at the injection site once on the day of vaccination and once daily for the next 3 days following vaccine administration.
Depending on the starting day of vaccination, t a, and on the maximum number of vaccines,, it is possible that some days there will be fewer individuals in a given epidemiological population than, the maximum number of vaccines available for that population.
Serum was sampled from all animals on the day of vaccination (day 0) and on days 28, 56 and 84 post-vaccination after which animals were culled.
Serum was sampled from all animals on the day of vaccination (day 0) and on days 28 and 56 before culling.
Local and general AEs were recorded by the study participants on a diary card on the day of vaccination and for the three subsequent days.
Local (pain, redness and swelling at the injection site) and systemic (arthralgia, fatigue, headache, myalgia, nausea, shivering and fever) AEs were recorded on the day of vaccination and for the six subsequent days.
