Dengvaxia Side Effects Center

Last updated on RxList: 6/23/2022
Dengvaxia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Dengvaxia?

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. Dengvaxia is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

What Are Side Effects of Dengvaxia?

Common side effects of Dengvaxia include:

Dosage for Dengvaxia

Dengvaxia is administered in three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12).

What Drugs, Substances, or Supplements Interact with Dengvaxia?

Dengvaxia may interact with immunosuppressive therapies, including

Tell your doctor all medications and supplements you use.

Dengvaxia During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Dengvaxia; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Dengvaxia during pregnancy.

  • It is unknown if Dengvaxia passes into breast milk.
  • Consult your doctor before breastfeeding.

Additional Information

Our Dengvaxia (dengue tetravalent vaccine, live) Suspension for Subcutaneous Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Dengvaxia Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of DENGVAXIA in subjects 9 through 16 years of age was evaluated in 9 randomized, placebo-controlled, multicenter clinical trials. In these studies, a total of 19,102 subjects 9 through 16 years of age received at least one dose of DENGVAXIA and 9,484 received placebo (0.9% sodium chloride). Overall, 50.9% of trial participants who received DENGVAXIA or placebo were female. Racial groups were reported as 18.9% Asian, 13% American Indian or Alaska native, 6.4% caucasian, 2.6% black, and 59.1% as other. In the largest study (Study 1, NCT01374516; N = 20,869) conducted in four Latin American countries and Puerto Rico, most subjects (99.9%) reported Hispanic ethnicity. All studies enrolled subjects irrespective of evidence of previous dengue infection.

Solicited Adverse Reactions

In a multi-center, observer-blind, randomized (2:1), placebo-controlled trial conducted in four Latin American countries and Puerto Rico (Study 1, NCT01374516), 2,000 subjects (out of a total of 20,869 subjects) were recruited during the first 2 months of enrollment for inclusion in the reactogenicity subset. Solicited adverse reactions were recorded daily for 14 days following each vaccination.

Table 1 presents the frequency and severity of solicited injection site reactions reported within 7 days and systemic adverse reactions reported within 14 days following receipt of DENGVAXIA or placebo.

Table 1: Percentages of Subjects with Solicited Injection Site Reactions within 7 Days and Systemic Adverse Reactions within 14 Days Following Receipt of Each Dose of DENGVAXIA or Placebo in Children and Adolescents 9 through 16 Years of Age in Study 1

  Dose 1 Dose 2 Dose 3
DENGVAXIA
%
N = 1,264-1,326
Placebo
%
N = 635-657
DENGVAXIA
%
N = 1,228-1,298
Placebo
%
N = 594-639
DENGVAXIA
%
N = 1,215-1,279
Placebo
%
N = 597 -631
Injection Site Reactions
Pain* Any Grade 3 32.4
0.8
26.3
0.9
25.6
0.5
16.4
0.0
22.5
0.9
16.5
0.3
Erythema Any Grade 3 4.1
0.0
4.7
0.2
1.9
<0.1
1.7
0.0
1.5
0.0
1.6
0.0
Swelling Any Grade 3 3.5
0.0
2.7
0.2
1.9
0.0
0.9
0.0
1.6
0.0
1.3
0.0
Systemic Adverse Reactions
Asthenia Any Grade 3 24.6
2.7
22.5
2.6
17.8
1.8
16.4
1.1
16.3
1.3
17.4
1.3
Fever§ Any Grade 3 6.8
1.7
6.6
1.1
5.9
0.8
7.1
1.2
7.3
1.1
8.7
0.8
Headache Any Grade 3 39.9
5.1
41.6
4.1
29.8
2.1
28.5
2.3
29.6
2.6
25.0
1.9
Malaise Any Grade 3 24.5
2.4
25.9
2.3
20.8
1.3
16.6
1.3
19.3
1.4
15.2
1.1
Myalgia Any Grade 3 29.2
2.2
27.4
1.5
21.0
1.6
15.8
0.8
20.0
1.5
18.4
0.8
N: range number of subjects with available data for the specified endpoints
Study 1, NCT01374516
Placebo: 0.9% sodium chloride
* For subjects 9 through 11 years of age – Grade 3: Incapacitating, unable to perform usual activities. For subjects 12 through 16 years of age – Grade 3: Significant; prevents daily activity.
For subjects 9 through 11 years of age – Grade 3: ≥50 mm. For subjects 12 through 16 years of age – Grade 3: >100 mm.
For all subjects – Grade 3: Significant; prevents daily activity.
§For all subjects – Any Fever: ≥38.0°C. Grade 3: ≥39.0°C.

Unsolicited Non-Serious Adverse Reactions

In Study 1, 1.2% of subjects in the DENGVAXIA group (16/1,333) and 0.8% of subjects in the placebo group (5/664) reported at least 1 unsolicited non-serious adverse reaction within 28 days following any dose.

In this study, 0.7% of the subjects in the DENGVAXIA group and 0.5% in the placebo group reported at least one unsolicited non-serious injection site adverse reaction. The unsolicited non-serious adverse reactions were injection site pain, hematoma, pruritus and anesthesia in the vaccine group and pain and induration in the control group.

In this study, 0.5% of the subjects in the DENGVAXIA group and 0.3% in the placebo group reported at least one unsolicited non-serious systemic adverse reaction. The unsolicited non-serious systemic adverse reactions were malaise, abdominal pain, vomiting, dyspnea, generalized erythema, vertigo, asthma crisis and urticaria in the vaccine group and pruritus and lymphadenitis in the control group.

Most unsolicited non-serious adverse reactions started within 3 days of any injection and resolved within 3 days or less.

A total of 2 subjects (one subject with asthma crisis and urticaria occurring the day of the first dose, and one subject with malaise occurring 20 days after the first dose) in the DENGVAXIA group (0.2%) and none in the placebo group reported unsolicited non-serious Grade 3 (significant; prevents daily activity) adverse reactions.

Severe Dengue Following Vaccination With DENGVAXIA And Subsequent Dengue Infection

Subjects were monitored for severe dengue from Day 0 (day of first study vaccination) to Month 60-72 (after first study vaccination) in three multi-center, observer-blind, randomized (2:1), placebo-controlled trials conducted in Latin America and Puerto Rico (Study 1, NCT01374516) and the Asia-Pacific region (Study 2, NCT01373281; Study 3, NCT00842530). A subset of 3,203 subjects (80.1%) enrolled in Study 3 were reconsented to participate in an extension study to evaluate safety of DENGVAXIA for 72 months (Study 4, NCT01983553). A total of 18,265 children and adolescents 9 through 16 years of age enrolled in these trials received at least one dose of DENGVAXIA. Table 2 presents the incidences and hazard ratios of severe dengue from Month 13 to Month 60-72 post-vaccination with DENGVAXIA or placebo in children and adolescents 9 through 16 years of age, by dengue baseline serostatus. An increased rate of severe dengue was observed following vaccination with DENGVAXIA and subsequent infection with any dengue virus serotype in persons not previously infected by dengue virus. [See WARNINGS AND PRECAUTIONS]

Table 2: Number of Events and Incidence of Severe Dengue* From Month 13 to Month 60-72 in Children 9 through 16 Years of Age, by Previous Dengue Infection Status, in Studies 1, 2, 3 and 4

Dengue Infection Status at Month 13 DENGVAXIA
n
(Incidence§ , %)
Placebo
n
(Incidence§ , %)
Hazard Ratio of Severe Dengue
(95% CI)
Previous Dengue Infection
(Dengue sero-positive at Month 13)
10
(0.068)
27
(0.401)
0.18
(0.09; 0.37)
No Previous Dengue Infection
(Dengue sero-negative at Month13
12
(0.380)
1
(0.069)
6.25
(0.81; 48.32)
n: number of subject with severe dengue cases
CI: confidence interval
Study 1, NCT01374516; Study 2, NCT01373281; Study 3, NCT00842530; Study 4, NCT01983553
* Severe Dengue according to IDMC (Independent Data Monitoring Committee) definition: Proven dengue fever (2 days fever + virological confirmation) plus one of the following: (a) Platelet count ≤100,000/μL and bleeding plus plasma leakage (effusion on chest x-ray [CXR] or clinically apparent ascites including imaging procedures or hematocrit ≥20% above baseline recovery level or standard for age if only one reading); (b) shock; (c) bleeding (requiring blood transfusion); (d) encephalopathy; (e) liver impairment; (f) impaired kidney function; (g) myocarditis, pericarditis or clinical heart failure.
The follow-up period corresponded to a minimum of 60 months for Study 1, a minimum of 63 months for Study 2 and 72 months for the combination of Study 3 and its extension, Study 4..
Based on measured Dengue anti-NS1 IgG ELISA at Month 13 from first vaccination (Dengue Seropositive= ≥9EU/mL).
§ Cummulative incidence over 4 years from 13 months after the first vaccination.

Non-Fatal Serious Adverse Events

In the 9 studies conducted among subjects 9 through 16 years of age (NCT 01374516, NCT01373281, NCT00842530, NCT00993447, NCT00875524, NCT00788151, NCT00880893, NCT01187433, NCT01254422), subjects were monitored for serious adverse events (SAEs) for at least 6 months after the last dose of DENGVAXIA.

The proportions of subjects who reported at least 1 non-fatal SAE within 28 days following any dose were 0.6% (123/19,102) in the DENGVAXIA group and 0.8% (73/9,484) in the placebo group. The following events were considered related to DENGVAXIA: asthma attack (day of Dose 1), urticaria (day of Dose 2) and convulsion (day of Dose 1).

The proportions of subjects who reported at least 1 non-fatal SAE after 28 days and up to 6 months after any dose were similar in the 2 groups: 2.8% in the DENGVAXIA group (534/19,102) and 3.2% in the placebo group (307/9,484). None of these SAEs were considered related to the vaccination.

Deaths

From the first administered dose up to Month 72, 51 deaths (0.3%) for subjects who received DENGVAXIA and 26 deaths (0.3 %) for subjects who received placebo were reported in the 9 studies conducted among subjects 9 though 16 years of age. None of the deaths were considered related to vaccination. Causes of death among subjects were consistent with those generally reported in children and adolescent populations.

Data From Post-Marketing Experience

In addition to events reported in clinical trials for DENGVAXIA, the following adverse events have been spontaneously reported during post-approval use. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to DENGVAXIA.

Immune System Disorders

Allergic including anaphylactic reactions.

Infections And Infestations

Severe dengue infection, including hospitalization and death, in individuals for whom dengue infection status prior to vaccination was unknown and who were subsequently infected with dengue following vaccination.

Read the entire FDA prescribing information for Dengvaxia (Dengue Tetravalent Vaccine, Live for Injection)

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow

© Dengvaxia Patient Information is supplied by Cerner Multum, Inc. and Dengvaxia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors