Study ID | Data collection | Serious Adverse Events (SAEs)** | Other adverse events | ||
Placebo | Intervention | Placebo | Intervention | ||
Cornuz 2008 | Specific safety check‐up one week after each injection (0‐4 months), self‐assessment diaries of local reactions | Overall: 3 SAEs. None attributable to treatment. |
Overall: 6 SAEs. Flu‐like symptoms associated with chest pain (1) |
Flu‐like symptoms (14/112); Pyrexia (9); Headache (30); Nasopharyngitis (29); Myalgia (6); Injection site discomfort (2) |
Flu‐like symptoms (159/229); Pyrexia (96); Headache (92); Nasopharyngitis (73); Myalgia (31); Injection site discomfort (45) |
Hatsukami 2011 | Subjects instructed to record reactogenicity events for 7 days after each injection (followed up until resolution or study completion); non‐serious treatment‐emergent AEs were recorded for 4 weeks after last injection; SAEs recorded up to 52 weeks |
Overall: 10 SAEs in 5 subjects. Herpes zoster (1) |
Overall: 8 SAEs in 7 subjects. Anaphylaxis (1) Herpes zoster (4) |
Pyrexia (10/100); Headache (61); Nasopharyngitis (14); Myalgia (86); Injection site discomfort (49) |
Pyrexia (21/201); Headache (138); Nasopharyngitis (18); Myalgia (171); Injection site discomfort (122) |