Sii Pneumosil Adverse Reactions

Summary of the safety profile: Safety assessment of SII PNEUMOSIL (10-valent) was based on clinical trials involving the administration of 5,416 doses to 1,828 healthy children as primary immunisation. Furthermore, 428 children received a booster dose of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (10-valent) following a primary vaccination course. SII PNEUMOSIL (10-valent) was administered concomitantly with recommended childhood vaccines, as appropriate.
Safety was also assessed in 57 previously unvaccinated children during the second year of life; all children received 2 doses of vaccine. SII PNEUMOSIL (10-valent) has also been used for booster vaccination in 56 children who received another pneumococcal conjugate vaccine for the primary course.
The vast majority of the reactions observed following vaccination were of mild or moderate severity and were of short duration.
In the largest study in infants, the most common adverse reactions observed after primary vaccination were tenderness at the injection site, fever and irritability, which were reported for approximately 49%, 52% and 32% of all infants, respectively. No increase in the incidence or severity was observed following subsequent doses of the primary vaccination course. Following booster vaccination, the most common adverse reaction was tenderness at the injection site, which was reported for approximately 8% of all infants.
The Indian Phase 3 licensure study in infants similarly showed tenderness at the injection site, fever and irritability as the most common adverse reactions observed after primary vaccination, with no change in the incidence or severity observed following subsequent doses of the primary vaccination course. Majority of the solicited AEs were of mild to moderate intensity and resolved completely.
The injection site and systemic reactions following catch-up vaccination or booster vaccination during the second year of life were similar to those reported after primary vaccination.
In all studies, the incidence and severity of local and general adverse reactions reported within 7 days of vaccination were similar to those after vaccination with the licensed comparator PCV.
Tabulated list of adverse reactions: Adverse reactions (i.e. events considered as related to vaccination) have been categorised by frequency for all age groups.
Frequencies are reported as: Very common (≥1/10 vaccinees); Common (≥1/100 vaccinees but <1/10 vaccinees); Uncommon (≥1/1000 vaccinees but <1/100 vaccinees); Rare (≥1/10,000 vaccinees but <1/1,000 vaccinees). (See Table 3.)

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