Pneumops 23 Adverse Reactions

Clinical Trial Experience with PPSV23: Two clinical trials (phase I and III) of PPSV23 were conducted in China, including 60 and 1660 subjects, respectively. Among all subjects (N=1720), subjects included in phase I clinical trial (N=60) and subjects in the PPSV23 group of phase III clinical trial (N=830) were administered with one dose of PPSV23. All subjects were observed for 30 minutes after immunization at the investigation site, and the investigator actively collected the systemic and local reactions through Day 0 to Day 7 after immunization. The adverse events/reactions were reported by the subjects or collected by regular follow-up from Day 8 to Day 30 post immunization.
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%) as follows: Very common: Local reaction(s): pain.
Common: Local reactions: redness, swelling, itching.
Systemic reactions: fever, fatigue, headache, diarrhea.
Uncommon: Local reaction(s): induration.
Systemic reactions: vomiting, rash, allergy.
Adverse Reactions in Phase III Clinical Trial: Incidence rates and severity of solicited adverse reactions by age groups: The incidence rates and severity of solicited adverse reactions post immunization in phase III clinical trial of PPSV23 in comparison to the comparator vaccine PNEUMOVAX 23 (pneumococcal vaccine polyvalent) manufactured by Merck Sharp & Dohme Ltd., (referred to as PNEUMOVAX 23) are summarized in Table 4 and Table 5. (See Tables 4 and 5.)

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Incidence rate and severity of unsolicited adverse reactions: The overall incidence rate of unsolicited adverse reactions reported by subjects in the PPSV23 group of Phase Ⅲ clinical trial for PPSV23 was 3.98% (33 cases among 830 subjects). The most common unsolicited adverse event was respiratory disease. The incidence of influenza/upper respiratory tract infection in PPSV23 group and PNEUMOVAX 23 group was 2.53% and 2.77%, respectively. No significant difference was observed in the incidence of each unsolicited adverse event between PPSV23 group and PNEUMOVAX 23 group. The documented symptoms include: influenza/upper respiratory tract infection, tonsillitis, pharyngitis, bronchitis, gastrorrhagia, gastroenteritis, vomiting, trauma, myalgia, stomatitis, toothache, systemic pruritus, keratitis, hand-foot-mouth disease, osteoproliferation, thyrophyma, cervical spondylosis, cerebral infarction, dizziness, gynecologic surgery etc.
Post-marketing Experience with PPSV23: The following adverse events have been reported through passive surveillance since the launch of the PPSV23. Considering that these events were reported voluntarily from a population of an uncertain size, the frequency of the events is not always possible to be reliably estimated and the causal relationship between the events and vaccination cannot be established due to the same reason.
The following adverse events were collected based on one or more of the undermentioned elements: frequency of reporting, severity, or strength of evidence for a causal relationship to PPSV23.
General disorders and administration site: fever, injection site swelling, injection site erythema, vaccination site induration.
Skin and subcutaneous tissue disorders: localized erythema, allergic rash, urticaria.
Immune system disorders: allergic reaction.
Infections and infestations: infection upper respiratory.
Nervous system disorders: fever convulsions.
If any adverse reactions not included as previously mentioned occur after administering this vaccine, please contact and report to a physician.