In the Child study, the booster dose of F17/Pre vaccine was
given approximately 12 months (year 1 visit) after completion
of the primary vaccination, and subjects had follow-up visits
at years 2, 3, 4, and 5 (post primary vaccinations) as shown
in Figure 1A.
In the Infant study, subjects had follow-up visits approximately
1 and 2 years after completion of the primary vaccination
and received a booster dose of F17 vaccine 41–46 months
(approximately 3.5 years) after dose 2 in the primary study,
at the year 3 visit. Only the infants who previously received
the F17/Pre vaccine were given a booster dose of F17,
although the infants from the control group were included in
the follow-up for safety over the 4 years. The last study visit
for infants occurred 1 year after the booster dose, at the year
4 visit (refer to Figure 1B for study visit timings).
The disposition of subjects in both studies is shown in Figure 2.
The objectives of the long-term follow-up studies were to
assess the levels of anti-DENV neutralizing antibodies and
any abnormal safety laboratory measures 12 months (Child
study) or 42 months (Infant study) after primary vaccination
completion. We also assessed the occurrence of dengue, particularly
illness prompting hospitalization, over either 4 or
5 years post primary vaccination. The objectives of the two
studies were similar except that the booster dose was administered
later in the Infant study with only 12 months of
follow-up post booster dose for levels of anti-DENV neutralizing
antibodies and dengue, with no safety laboratory endpoints
collected beyond 30 days post booster.
Study participants. At the time of reenrollment into the
follow-up/booster studies, which occurred approximately
6 months to 1 year after completion of the primary studies,
the children were 7–8 years of age and the infants were
approximately 2 years of age (Figure 1).
In the Child study, the booster dose of F17/Pre vaccine wasgiven approximately 12 months (year 1 visit) after completionof the primary vaccination, and subjects had follow-up visitsat years 2, 3, 4, and 5 (post primary vaccinations) as shownin Figure 1A.In the Infant study, subjects had follow-up visits approximately1 and 2 years after completion of the primary vaccinationand received a booster dose of F17 vaccine 41–46 months(approximately 3.5 years) after dose 2 in the primary study,at the year 3 visit. Only the infants who previously receivedthe F17/Pre vaccine were given a booster dose of F17,although the infants from the control group were included inthe follow-up for safety over the 4 years. The last study visitfor infants occurred 1 year after the booster dose, at the year4 visit (refer to Figure 1B for study visit timings).The disposition of subjects in both studies is shown in Figure 2.The objectives of the long-term follow-up studies were toassess the levels of anti-DENV neutralizing antibodies andany abnormal safety laboratory measures 12 months (Childstudy) or 42 months (Infant study) after primary vaccinationcompletion. We also assessed the occurrence of dengue, particularlyillness prompting hospitalization, over either 4 or5 years post primary vaccination. The objectives of the twostudies were similar except that the booster dose was administeredlater in the Infant study with only 12 months offollow-up post booster dose for levels of anti-DENV neutralizingantibodies and dengue, with no safety laboratory endpointscollected beyond 30 days post booster.Study participants. At the time of reenrollment into thefollow-up/booster studies, which occurred approximately6 months to 1 year after completion of the primary studies,the children were 7–8 years of age and the infants wereapproximately 2 years of age (Figure 1).
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