Table 5: Safety and Reactogenicity of the CYD-TDV as compared to control in the 6 trials Study Severe adverse effects Solicited injection site AEs Solicited Systemic AEs Unsolicited AEs Overall Comments
Sabchareon, et al( 2012)
No severe adverse effects were vaccine related n test group, but one was in placebo group
Injection site reactions occurred in 61.6 % patients in test groups, and in 63.2 % of patients in control group
Solicited systemic side effects such as malaise and fever occurred in 77.7 % of patients in test group, and 74.3 % patients in control group, but were mostly low grade and transient
Unsolicited Adverse effects occurred at similar effects in both groups( 45 % of patients in vaccine group, 47 % of the patients in control group)
The vaccine was well tolerated and there were no SAEs related to the vaccine in a two year follow up
Villar, et al( 2013) 10( 2.5 %) patients in study group, and 15( 7.5 %) patients in control group experienced SAEs, none of which were considered vaccine related
32 % CYD TDV group and 27 % Placebo group experienced solicited injection site reaction( mild or moderate severity)
58 % CYD-TDV group and 54 % Placebo group experienced solicited systemic reaction( mild or moderate severity)
- Favorable safety profile, with vaccine being well tolerated
Leo, et al( 2013) 1( 0.3 %) discontinuation after AE in the control group and 3( 0.3 %) for AEs related to vaccination in the CYD- TDV group: Fever, rash, and worsening cervical spondylosis
55 % patients in the CYD- TDV group and 67 % in control group had solicited injection-site reactions after vaccination
More solicited systemic reactions reported after first CYD-TDV vaccination( 45.9 %) than after the placebo control( 37.0 %). Headache, myalgia, and malaise most frequently reported solicited systemic reactions, followed by fever and asthenia
Unsolicited AEs were reported by 17.0 % of participants in the CYD-TDV group and 20.7 %, most frequent of which were infections and infestations of upper respiratory tract infections, which were considered not related to vaccination
Relatively safe overall profile in terms of reactogenicity and AEs