Qdenga dengue tetravalent vaccine (live, attenuated) dengue virus serotypes 1, 2, 3, and 4.
Qdenga is a vaccine approved to provide protection against dengue disease for adults, adolescents, and children aged 4 years and over. Qdenga contains the active ingredients dengue virus serotype 1, 2, 3 and 4 (live, attenuated).
Qdenga is a vaccine that helps protect against the dengue virus. The vaccine can be given to adults, adolescents and children from 4 years of age. Qdenga contains live, attenuated (weakened) versions of dengue virus serotypes 1, 2, 3 and 4.
Dengue is a mosquito-borne viral disease caused by all 4 dengue virus serotypes. A serotype is a subgroup of a virus. The dengue virus is spread by the Aedes mosquito. If a mosquito bites someone with dengue, it can pass the virus onto the next person it bites. Dengue is not passed directly from person-to-person.
Qdenga works by stimulating the body’s natural defences (immune system). The vaccine teaches your body to produce the specific immune response needed to protect against dengue virus if the body is exposed to the virus in the future.
Although Qdenga contains live, attenuated (weakened) versions of the dengue viruses, they do not cause dengue disease in healthy people.
Qdenga is given as an injection just under the skin (subcutaneous injection), in the upper arm, by a doctor or trained healthcare professional. You will be given the first dose, followed by a second dose 3 months after the first injection to complete the vaccination schedule.
The effectiveness of Qdenga was assessed in a single major study, held across 8 countries in South/Central America and Asia, where more than 20,000 children were given Qdenga, or the placebo (an injection with no active ingredients).
Other clinical studies assessed the vaccine’s effect on antibody blood levels for each dengue disease serotype. Safety was assessed in people aged 4-60 years, after they received both doses of Qdenga, or the placebo, three months apart.
Key findings from clinical studies
- In children aged 4 to 16 years, the vaccine was shown to be effective in preventing dengue fever disease. Between 30 days and 12 months, after the second vaccine dose, there was an 80% reduction in the number of dengue fever cases caused by confirmed dengue virus, in those who had received the vaccine compared to those who hadn’t.
- In the same study, the vaccine also reduced hospitalisations caused by dengue disease, 30 days to 18 months after the second dose.
- In the same study, 2,518 subjects who received 2 doses of Qdenga, showed an increase in antibody measures for each serotype to well above pre-vaccination levels for up to 51 months.
In clinical studies assessing safety, the most common adverse events (undesirable events) reported after having Qdenga, were:
- injection site pain and/or redness
- headache
- muscle pain
- malaise
- physical weakness
- fever
These events are usually mild to moderate in severity and resolve within a few days. They are less frequent after the second dose of the vaccine, compared to the first.
- Qdenga is generally well tolerated, with no significant safety concerns identified for up to 4.5 years following primary vaccination in the clinical studies or post-marketing data to date.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Qdenga and the medicine can be registered in Australia.
More detailed information on why the TGA approved Qdenga will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Qdenga can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Qdenga can be accessed through the searchable TGA eBusiness Services or ARTG databases.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
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