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.

Table 3: Efficacy of DENGVAXIA against Symptomatic VCD in Subjects Seropositive for Dengue at Baseline from 28 Days Post Dose 3 for a Period of 12 months – Study 1 (Ages 9 through 16 Years) and Study 2 (Ages 9 through 14 Years) – mFASE * – Subjects Included in the Immunogenicity Subset
DENGVAXIA group Cases (Subjects) Placebo group Cases (Subjects) VE % (95% CI)
*
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.
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 -- Kit Carton
(click image for full-size original)

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 -- 0.5 mL Vial Label
(click image for full-size original)

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®

PRINCIPAL DISPLAY PANEL -- 0.6 mL Vial Label
(click image for full-size original)
DENGVAXIA dengue tetravalent vaccine, live kit
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-605
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-605-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 0.5 mL
Part 2 1 VIAL, SINGLE-DOSE 0.6 mL
Part 1 of 2
DENGVAXIA dengue tetravalent vaccine, live injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:49281-606
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYD DENGUE VIRUS SEROTYPE 1 LIVE (ATTENUATED) ANTIGEN (CYD DENGUE VIRUS SEROTYPE 1 LIVE (ATTENUATED) ANTIGEN) CYD DENGUE VIRUS SEROTYPE 1 LIVE (ATTENUATED) ANTIGEN 100000 [CCID_50] in 0.5 mL
CYD DENGUE VIRUS SEROTYPE 2 LIVE (ATTENUATED) ANTIGEN (CYD DENGUE VIRUS SEROTYPE 2 LIVE (ATTENUATED) ANTIGEN) CYD DENGUE VIRUS SEROTYPE 2 LIVE (ATTENUATED) ANTIGEN 100000 [CCID_50] in 0.5 mL
CYD DENGUE VIRUS SEROTYPE 3 LIVE (ATTENUATED) ANTIGEN (CYD DENGUE VIRUS SEROTYPE 3 LIVE (ATTENUATED) ANTIGEN) CYD DENGUE VIRUS SEROTYPE 3 LIVE (ATTENUATED) ANTIGEN 100000 [CCID_50] in 0.5 mL
CYD DENGUE VIRUS SEROTYPE 4 LIVE (ATTENUATED) ANTIGEN (CYD DENGUE VIRUS SEROTYPE 4 LIVE (ATTENUATED) ANTIGEN) CYD DENGUE VIRUS SEROTYPE 4 LIVE (ATTENUATED) ANTIGEN 100000 [CCID_50] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
AMINO ACIDS, ESSENTIAL 0.56 mg in 0.5 mL
AMINO ACIDS 0.2 mg in 0.5 mL
ARGININE HYDROCHLORIDE 2.5 mg in 0.5 mL
PHENYLALANINE 0.56 mg in 0.5 mL
SUCROSE 18.75 mg in 0.5 mL
TREHALOSE DIHYDRATE 13.75 mg in 0.5 mL
SORBITOL 9.38 mg in 0.5 mL
TROMETHAMINE 0.18 mg in 0.5 mL
UREA 0.63 mg in 0.5 mL
SODIUM CHLORIDE 2 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-606-58 0.5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125682 05/01/2019
Part 2 of 2
SALINE DILUENT sodium chloride injection
Product Information
Item Code (Source) NDC:49281-549
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-549-58 0.6 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125682 05/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125682 05/01/2019
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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