DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(六)
ommittee) 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 (effusionon chest x-ray [CXR] or clinically apparent ascites including imaging procedures or hematocrit ≥20% above baseline recoverylevel 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 72months 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).
Cumulative 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) forat 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 anydose were 0.6% (123/19,102) in the DENGVAXIA group and 0.8% (73/9,484) in the placebogroup. The following events were considered related to DENGVAXIA: asthma attack (day ofDose 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 6months 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 consideredrelated to the vaccination.
Deaths
From the first administered dose up to Month 72, 51 deaths (0.3%) for subjects who receivedDENGVAXIA and 26 deaths (0.3 %) for subjects who received placebo were reported in the 9studies conducted among subjects 9 though 16 years of age. None of the deaths were consideredrelated to vaccination. Causes of death among subjects were consistent with those generallyreported in children and adolescent populations.
6.2 Data from Post-marketing Experience
In addition to events reported in clinical trials for DENGVAXIA, the following adverse eventshave 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 theirfrequency 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 toDENGVAXIA.
Immune system disorders
Allergic including anaphylactic reactions.
Infections and infestations
Severe dengue infection, including hospitalization and death, in individuals for whomdengue infection status prior to vaccination was unknown and who were subsequently
infected with dengue following vaccination.
7 DRUG INTERACTIONS
7.1 Concomitant Administration with Other Vaccines
Data are not available to establish the safety and immunogenicity of concomitant administrationof DENGVAXIA with recommended adolescent vaccines.
7.2 Immunosuppressive Treatment |
