All pre-licensing clinical safety trials of PCV15 in adults compared the vaccine to PCV13. In clinical trials, common side effects reported following vaccination included injection site pain, redness, and swelling, headache, fatigue, muscle pain, and joint stiffness. Higher reaction rates were reported in those individuals receiving PCV15.
There were nine serious adverse events (SAE) in the PCV15 group and 13 SAEs in the PCV13 group. Two cardiac SAEs (arrythmia and myocardial infarction) were reported among PCV15 recipients. No other details on SAEs in either group were disclosed but trial investigators reported that all SAEs were unrelated to vaccination.
During the clinical trial phase, one death occurred in both the PCV15 and PCV13 groups. A 74-year-old male with a history of atrial fibrillation died of unknown causes 55 days post vaccination with PCV15 and an 82-year-old male with a history of heart disease died of an arrythmia and an acute myocardial infarction 87 days post vaccination. In the safety follow-up period (40 or more days post vaccination), there were eight deaths among those who received PCV15, compared to three deaths among PCV13 vaccine recipients. Trial investigators determined all deaths to be unrelated to vaccination.
Pre-licensing clinical safety of PCV15 in infants and children compared this vaccine to the PCV13 vaccine. Infants and children in the study also received Pentacel, a combination Diphtheria and Tetanus Toxoids and acellular pertussis, inactivated poliovirus (IPV) and Haemophilus b Conjugate (HIB) Vaccine (DTaP-IPV-Hib vaccine) or a similar non-US-licensed DTaP-IPV-Hib product in studies conducted outside the U.S. at two, four, and six months of age. Additional vaccines administered at two, four, and six months included rotavirus vaccine (RotaTeq) and Hepatitis B (RECOMBIVAX HB). At 12 through 15 months, when the fourth dose was administered, clinical trial participants also received the MMR, Varicella, Hepatitis A, and HIB vaccines concomitantly.
According to the package insert, in infants and children who received four doses of PCV15 at two, four, six, and 12-15 month, the most common adverse events were irritability, drowsiness, injection site pain, fever greater than 38.0°, decreased appetite, and injection site redness, induration, and swelling. Nearly 10 percent of infants and children in the PCV15 group and 9 percent in the PCV13 group experienced a serious adverse event up to six months after dose one and all additional vaccines.
In children and adolescents age two through 17, the most common adverse reactions reported after vaccination with a single dose of PCV15 were injection site pain, muscle pain, injection site redness and swelling, fatigue, headache, and injection site induration.
