DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(十)
onfirmedengue (VCD) starting at Day 0. Per protocol vaccine efficacy was assessed beginning 28 daysafter the third vaccination for 12 months. VCD was defined as an acute febrile illness(temperature ≥38°C on at least 2 consecutive days) virologically-confirmed by dengue RT-PCRand/or dengue non-structural protein 1 (NS1) ELISA Antigen Test. For each study, in prespecifiedvaccine efficacy analyses including the full age range of subjects enrolled, thepre-specified criterion for demonstrating efficacy of DENGVAXIA against VCD due to anydengue virus serotype and irrespective of previous dengue virus infection, was met (lower boundof 95% CI for vaccine efficacy >25%). These studies were not designed to demonstrate efficacy
of DENGVAXIA against individual dengue serotypes.
Given the identification of the increased risk for severe dengue following vaccination withDENGVAXIA and subsequent infection with dengue virus in persons not previously infectedwith dengue virus [see Adverse Reactions (6.1)], Table 3 presents analyses of vaccine efficacyagainst VCD due to any dengue virus serotype, limited to subjects who had baseline seraeva luated and who were dengue seropositive at baseline. These analyses include subjects 9through 16 years of age from Study 1 and subjects 9 through 14 years of age from Study 2.
Table 3: Efficacy of DENGVAXIA against Symptomatic VCD in Subjects Seropositive forDengue at Baseline from 28 Days Post-Dose 3 for a Period of 12 months – Study 1 (Ages 9through 16 Years) and Study 2 (Ages 9 through 14 Years) – mFASE* – Subjects Includedin the Immunogenicity Subset
DENGVAXIA group
Cases (Subjects)
Placebo group
Cases (Subjects) VE % (95% CI)†
Study 1
(Subjects 9 through 16 years of age)
7 (1034) 17 (492) 80.6 (50.7;93.2)
Study 2
(Subjects 9 through 14 years of age) 4 (483) 9 (250) 77.2 (18.3;94.9)
*mFASE (Modified Full Analysis Set): Set of the subjects who received 3 injections as per randomization including those with
protocol deviations.
VE is calculated as 1- ratio of density incidence of dengue between DENGVAXIA and Placebo groups.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
An outer package of 1 dose (NDC 49281-605-01) contains 1 single dose vial of LyophilizedVaccine Antigen (NDC 49281-606-58) and 1 single dose vial of Saline Diluent
(NDC 49281-546-68).
The vial stoppers for the Lyophilized Vaccine Antigen vials and the Saline Diluent vials ofDENGVAXIA are not made with natural rubber latex.
16.2 Storage and Handling
Store Lyophilized Vaccine Antigen and Saline Diluent in a refrigerator at 2C to 8C (36F to46F). Do not freeze. Protect from light.
Do not use after the expiration date shown on the vial labels of the Lyophilized Vaccine Antigenand Saline Diluent.
After reconstitution, administer DENGVAXIA immediately or store refrigerated at 2C to 8C(36F to 46F) and use within 30 minutes. Discard reconstituted vaccine if not used within 30minutes.
17 PATIENT COUNSELING INFORMATION
Educate vaccine recipients regarding the most common adverse reactions that occur within 14days following administration of DENGVAXIA (headache, injection site pain, malaise, asthenia,and myalgia).
Inform individuals to seek medical care if they develop signs and symptoms of dengue feverwith particular attention to severe dengue warning signs (e.g., high fever, s |
