Weuphoria Adverse Reactions

Clinical Trials for PCV13-TT: Two clinical trials (phase I and III) of the vaccine (PCV13-TT) were conducted in China, including 120 and 2760 subjects, respectively; among all subjects (2880), 1754 have been vaccinated with at least one dose of PCV13-TT. The safety observations were conducted in a systematic fashion for all subjects, starting from the first dose of vaccination, and the safety observation lasted for 30 days post each dose of vaccination. For a majority of subjects excluding the dropout, the long-term safety observation period started from the first vaccination till 180 days post the last dose of vaccination (after complete series).
Summary: The incidence rates of adverse reactions reported in clinical trials, according to the guidance on classifications of adverse events recommended by The Council for International Organizations of Medical Sciences (CIOMS), are classified as: very common (≥ 10%), common (≥ 1% to < 10%), uncommon (≥ 0.1% to < 1%), rare (≥ 0.01% to < 0.1%) and very rare (< 0.01%). The safety data for the primary series of PCV-13 collected from both phase I and phase III clinical trials of all subjects are summarized as follows: Systemic adverse reactions: Very common: fever, diarrhea.
Common: crying, coughing, nausea/vomiting, fatigue/somnolence, allergic reaction.
Uncommon: myalgia.
Local adverse reactions: Very common: redness.
Common: swelling, pain, induration.
Uncommon: pruritus.
Rare: rash (vaccination site).
Serious adverse reactions: One case of serious adverse event (SAE) was reported during the primary series in the 3-months age group. This SAE was reported to be fever and considered to be possibly related to PCV13-TT. Other serious adverse events were adjudicated to be irrelevant to PCV13-TT.
Adverse Reactions in Phase III Clinical Trial: The incidence rates and severity of solicited adverse reactions: The incidence rates and severity of solicited adverse reactions post primary and booster immunization in phase III clinical trial of PCV13-TT comparing to the comparator vaccine (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein], referred to as Prevnar) are summarized in Table 11 and Table 12. (See Tables 11 and 12.)

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Incidence rates and severity of unsolicited adverse reactions: The incidence rates of unsolicited adverse reactions for PCV13-TT were 0.06%-0.73% with most episodes being grade 1 in severity. The documented symptoms include: nasal obstruction, rhinorrhea, nasopharyngitis, upper respiratory tract infection, oral ulcer, abdominal pain, abdominal distension, decreased appetite, hyperhidrosis, increased tearing and eye discharge and red eyelids.