FluQuadri

FluQuadri Adverse Reactions

vaccine, influenza

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.
Children 6 Months through 8 Years of Age: In a multi-center study conducted in the US, children 6 months through 35 months of age received one or two 0.25 mL doses of either FluQuadri or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either FluQuadri, TIV-1, or TIV-2. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in FluQuadri (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). For participants who received two doses, the doses were administered approximately 4 weeks apart. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age.
In children 6 months through 35 months of age, the most common (≥10%) injection-site reactions were pain (57.0%)a or tenderness (54.1%)b, erythema (37.3%), and swelling (21.6%); the most common solicited systemic adverse reactions were irritability (54.0%)b, abnormal crying (41.2%)b, malaise (38.1%)a, drowsiness (37.7%)b, appetite loss (32.3%)b, myalgia (26.7%)a, vomiting (14.8%)b, and fever (14.3%). In children 3 years through 8 years of age, the most common (≥10%) injection-site reactions were pain (66.6%), erythema (34.1%), and swelling (24.8%); the most common solicited systemic adverse reactions were myalgia (38.6%), malaise (31.9%), and headache (23.1%).
During the 28 days following vaccination, a total of 16 (0.6%) recipients in the FluQuadri group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE; no deaths occurred. Throughout the study period, a total of 41 (1.4%) recipients in the FluQuadri group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. Three SAEs were considered to be possibly related to vaccination: croup in a FluQuadri recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. One death occurred in the TIV-1 group (a drowning 43 days post-vaccination).
a Assessed in children 24 months through 35 months of age
b Assessed in children 6 months through 23 months of age
0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age: In a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US, 1950 children 6 months through 35 months of age were randomly assigned to receive FluQuadri administered in either a volume of 0.25 mL (Group 1) or 0.5 mL (Group 2). For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine.
Solicited reactions within 7 days after vaccination were assessed. Among the 1941 participants who received at least 1 dose of study vaccine, the frequency of solicited injection-site reactions (Group 1 vs. Group 2) were tenderness (47% vs. 50%), erythema (23% vs. 24%), and swelling (13% vs. 15%); the frequency of systemic adverse reactions were irritability (47% vs. 49%), abnormal crying (33% vs. 34%), drowsiness (32% vs. 31%), appetite loss (27% vs. 28%), fever of ≥100.4°F (11% vs. 12%), and vomiting (10% vs. 10%). The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates <5%). Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and5 (0.5%) in Group 2.
Adults: In a multi-center trial conducted in the US, adults 18 years of age and older received one dose of either FluQuadri or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in FluQuadri (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older.
In adults 18 years and older, the most common (≥10%) injection-site reaction was pain (47.4%); the most common solicited systemic adverse reactions were myalgia (23.7%), headache (15.8%), and malaise (10.5%).
In the follow-up period, there were two SAEs, 1 (0.5%) in the FluQuadri group and 1 (0.5%) in the TIV-2 group. No deaths were reported during the trial period.
Geriatric Adults: In a multi-center trial conducted in the US, adults 65 years of age and older received one dose of either FluQuadri, or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in FluQuadri (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The safety analysis set included 675 recipients.
In adults 65 years of age and older, the most common (≥10%) injection-site reaction was pain (32.6%); the most common solicited systemic adverse reactions were myalgia (18.3%), headache (13.4%), and malaise (10.7%).
Three SAEs were reported during the follow-up period, 2 (0.9%) in the TIV-1 group and 1 (0.4%) in the TIV-2 group. No deaths were reported during the trial period.
Reporting adverse reactions: Persons who receive the vaccine and their guardians should be instructed to report any adverse or unusual reaction to their healthcare provider.
Post-Marketing Experience: Currently, there are no post-marketing data available for FluQuadri vaccine.
The following events have been spontaneously reported during the post-approval use of the trivalent formulation of Fluzone. 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 vaccine exposure. 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 Fluzone.
Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy.
Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema).
Eye Disorders: Ocular hyperemia.
Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia.
Vascular Disorders: Vasculitis, vasodilation/flushing.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness.
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome.
General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain.
Gastrointestinal Disorders: Vomiting.
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