RSV glycoprotein F antigen interacts in the following cases:
Safety and immunogenicity data on adjuvanted RSVPreF3 vaccine are not available for immunocompromised individuals. Patients receiving immunosuppresive treatment or patients with immunodeficiency may have a reduced immune response to adjuvanted RSVPreF3 vaccine.
There are no data from the use of adjuvanted RSVPreF3 vaccine in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with an investigational unadjuvanted RSVPreF3 vaccine and results with adjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Adjuvanted RSVPreF3 vaccine is not recommended during pregnancy.
There are no data on the excretion of adjuvanted RSVPreF3 vaccine in human or animal milk. The vaccine is not recommended in breast-feeding/lactating women.
There are no data on the effects of adjuvanted RSVPreF3 vaccine on human fertility. Animal studies with an investigational unadjuvanted RSVPreF3 vaccine or adjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
No studies on the effects of adjuvanted RSVPreF3 vaccine on the ability to drive and use machines have been performed.
The vaccine has a minor influence on the ability to drive and use machines. Some of the undesirable effects (e.g. fatigue) may temporarily affect the ability to drive or use machines.
The safety profile presented below is based on a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥60 years of age in which more than 12 000 adults received one dose of adjuvanted RSVPreF3 vaccine and more than 12 000 received placebo.
In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Most other adverse reactions were uncommon and similarly reported between the study groups.
Adverse reactions are listed below by MedDRA system organ class and frequency.
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000)
Adverse reactions:
| System Organ Class | Frequency | Adverse reactions |
|---|---|---|
| Blood and lymphatic system disorders | Uncommon | lymphadenopathy |
| Immune system disorders | Uncommon | hypersensitivity reactions (such as rash) |
| Nervous system disorders | Very common | headache |
| Gastrointestinal disorders | Uncommon | nausea, abdominal pain, vomiting |
| Musculoskeletal and connective tissue disorders | Very common | myalgia, arthralgia |
| General disorders and administration site conditions | Very common | injection site pain, fatigue |
| Common | injection site erythema, injection site swelling, fever, chills | |
| Uncommon | injection site pruritus pain, malaise |
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