Pneumocon 13 Adverse Reactions

Clinical Trials for PCV13-TT: Two clinical trials (phase I and III) of PCV13-TT were conducted in China, including 120 and 2760 subjects, respectively; among all subjects (N=2880), 1754 had been vaccinated with at least one dose of PCV13-TT. The adverse events were observed through safety follow-up for all subjects, starting from the first dose through 7 days and 30 days post each dose for solicited and unsolicited adverse events, with long-term safety monitoring conducted until around 6 months after the last vaccination for serious adverse events (SAES).
Summary: The incidence rates of adverse reactions reported in clinical trials, according to the guidance on classifications of adverse reactions 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 PCV13-TT collected from both phase I and phase III clinical trials of all subjects are summarized as follows: See Table 11.

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Adverse Reactions in Phase III Clinical Trial: Serious Adverse Events: SAEs were collected from Dose 1 till 180 days post complete series. In phase III, 1 case of SAE was reported during the primary series in the PCV13-TT (3 months of age) group (please refer to Table 9 for dosing regimen for subjects aged 3 months in PCV13-TT group). This SAE was reported to be fever and considered to be possibly related to PCV13-TT. Other SAEs were adjudicated to be irrelevant to PCV13-TT.
The Incidence Rates and Severity of Solicited Adverse Reactions: The incidence rates and severity of solicited adverse reactions post primary series and booster dose in phase III clinical trial of PCV13-TT comparing to the comparator vaccine (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein], referred to as Prevenar) are summarized in Table 12 and Table 13. (See Tables 12 and 13.)

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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.