pertagen Adverse Reactions

Summary of the safety profile: The safety profile presented as follows is based on data from a clinical trial where Pertagen was administered to 150 adolescents between 12 and 17 years of age. Within 7 days after vaccination, the most common events occurring were local injection site pain and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia). Frequency, severity and duration of adverse reactions were similar in subjects vaccinated either with Pertagen or with a licensed Tdap vaccine. These signs and symptoms were mostly mild and moderate in intensity and resolved without sequelae.
Tabulated summary of adverse reactions: Adverse reactions are listed according to the following frequency: 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). (See Table 3.)

Click on icon to see table/diagram/image

In another clinical trial, a formulation of recombinant acellular pertussis vaccine containing PRN (Pertactin antigen) in addition to the Pertagen antigens (rPT and FHA) was tested in 20 healthy adult subjects aged 18-35 years. Subjects vaccinated with this vaccine had similar frequency of adverse events following 7 days after vaccination to subjects vaccinated with a licensed Tdap vaccine. (See Table 4.)

Click on icon to see table/diagram/image