Menveo Adverse Reactions

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as follows: 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); Not known (cannot be estimated from the available data).
Adverse reactions from clinical trials: Children 2 to 10 years of age: Overall 3464 subjects aged 2 to 10 years were exposed to Menveo in completed clinical trials. The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.
The most common adverse reactions during the clinical trials generally persisted for one to two days and were not severe. These adverse reactions were: Metabolism and nutrition disorders: Very Common: eating disorders.
Nervous system disorders: Very common: sleepiness, headache.
Gastrointestinal disorders: Common: nausea, vomiting, diarrhea.
Skin and subcutaneous tissue disorders: Common: rash.
Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia.
General disorders and administration site conditions: Very common: irritability, malaise, injection site pain, injection site erythema (≤ 50 mm), injection site induration (≤ 50 mm).
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38°C.
Uncommon: injection site pruritus.
Individuals 11 to 65 years of age: The characterization of the safety profile of Menveo in adolescents and adults is based on data from five randomized controlled clinical trials including 6,401 participants (from 11-65 years of age) who received Menveo. Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively. The two primary safety studies were randomized, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups. The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipients subjects aged 11-55.
The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.
The list provided as follows presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class. The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.
Nervous system disorders: Very common: headache.
Uncommon: dizziness.
Gastrointestinal disorders: Very common: nausea.
Skin and subcutaneous tissue disorders: Common: rash.
Musculoskeletal and connective tissue disorders: Very common: myalgia.
Common: arthralgia.
General disorders and administration site conditions: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm), malaise.
Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills.
Uncommon: injection site pruritus.
In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.
Post-marketing experience (all age groups): Blood and lymphatic system disorders: Local lymphadenopathy.
Immune system disorders: Not known: hypersensitivity including anaphylaxis.
Nervous system disorders: Not known: tonic convulsion, febrile convulsion, syncope.
Ear and labyrinth disorders: Not known: vertigo.
General disorders and administration site conditions: Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb.