Vaccine Information: DENGVAXIA (Page 3 of 3)
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
DENGVAXIA has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility. Exposure of female rabbits to DENGVAXIA prior to and during gestation did not impair fertility. [See Use in Specific Populations (8.1).]
14 CLINICAL STUDIES
14.1 Efficacy
The efficacy of DENGVAXIA was evaluated in two randomized, observer-blind, placebo-controlled, multi-center studies. Study 1 (N=20,869) was conducted in individuals 9 through 16 years of age in four Latin American countries and Puerto Rico; and Study 2 (N=10,275) was conducted in individuals 2 through 14 years of age in five Asia-Pacific countries. A subset of subjects in each study (10% in Study 1; 20% in Study 2) was evaluated for antibodies to dengue virus at the time of enrollment and at later time points. Both studies enrolled subjects irrespective of evidence of previous dengue infection. Subjects were randomized 2:1 to receive either DENGVAXIA or saline placebo and were monitored for symptomatic virologically confirmed dengue (VCD) starting at Day 0. Per protocol vaccine efficacy was assessed beginning 28 days after 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-PCR and/or dengue non-structural protein 1 (NS1) ELISA Antigen Test. For each study, in pre-specified vaccine efficacy analyses including the full age range of subjects enrolled, the pre-specified criterion for demonstrating efficacy of DENGVAXIA against VCD due to any dengue virus serotype and irrespective of previous dengue virus infection, was met (lower bound of 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 with DENGVAXIA and subsequent infection with dengue virus in persons not previously infected with dengue virus [see Adverse Reactions (6.1)] , Table 3 presents analyses of vaccine efficacy against VCD due to any dengue virus serotype, limited to subjects who had baseline sera evaluated and who were dengue seropositive at baseline. These analyses include subjects 9 through 16 years of age from Study 1 and subjects 9 through 14 years of age from Study 2.
| 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) |
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 Lyophilized Vaccine Antigen (NDC 49281-606-58) and 1 single dose vial of Saline Diluent (NDC 49281-549-58).
The vial stoppers for the Lyophilized Vaccine Antigen vials and the Saline Diluent vials of DENGVAXIA are not made with natural rubber latex.
16.2 Storage and Handling
Store Lyophilized Vaccine Antigen and Saline Diluent in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Do not use after the expiration date shown on the vial labels of the Lyophilized Vaccine Antigen and Saline Diluent.
After reconstitution, administer DENGVAXIA immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes. Discard reconstituted vaccine if not used within 30 minutes.
17 PATIENT COUNSELING INFORMATION
Educate vaccine recipients regarding the most common adverse reactions that occur within 14 days 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 fever with particular attention to severe dengue warning signs (e.g., high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence and hyperactivity).
Register women who receive DENGVAXIA during pregnancy in the Pregnancy Registry by calling 1-800-822- 2463 (1-800-VACCINE). [See Pregnancy (8.1).]
Instruct vaccine recipients to report adverse reactions to their healthcare provider.
Manufactured and distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
DENGVAXIA® is a registered trademark of Sanofi, its affiliates and its subsidiaries.
PRINCIPAL DISPLAY PANEL — Kit Carton
NDC 49281-605-01
NOTICE: One vial of
Lyophilized Vaccine Antigen and
0.6 mL from the vial of Saline Diluent
MUST BE COMBINED BEFORE USE.
Dengue Tetravalent
Vaccine, Live
Dengvaxia®
Rx only
For 9 through 16 years of age
Contents (a single dose of Dengvaxia®):
1 vial containing Lyophilized Vaccine Antigen,
1 vial containing Saline Diluent (0.4% Sodium
Chloride). After reconstitution, a single dose ofDengvaxia® is 0.5 mL.
SANOFI PASTEUR
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label
Lyophilized Vaccine Antigen –
Reconstitute with Saline
Diluent (0.4% NaCl) to form
Dengvaxia®
0.5 mL Single Dose after Reconstitution
Subcutaneous use
Dengvaxia®
NDC 49281-606-58Rx only
Mfd by: Sanofi Pasteur Inc.
L
7616
PRINCIPAL DISPLAY PANEL — 0.6 mL Vial Label
Saline Diluent
(0.4% Sodium Chloride)
NOT TO BE USED ALONE
Rx only
Add to 1 vial of
Lyophilized Vaccine
Antigento form Dengvaxia®
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| Labeler — Sanofi Pasteur Inc. (086723285) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Pasteur Inc. | 086723285 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Pasteur VDR | 766693436 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Pasteur NVL | 260680254 | MANUFACTURE | |
Revised: 01/2023 Sanofi Pasteur Inc.
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