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
Dayan, et al 6 Severe Adverse
( 2013) reactions in CYD-TDV and 5 adverse reactions in control groups; none considered to be related to the intervention
Pain was the most common injection-site side effect( 40-41 % patients in both groups). Most solicited injection site AEs were low grade and transient
Headache was the most common solicited systemic AE( 61 % patients in test; 51 % patients in placebo). Most solicited systemic AEs were low grade and transient
No difference in occurrence of unsolicited systemic AEs in test and control groups. Unsolicited AEs were not related to the interventions / control studied.
In general, the vaccine was well tolerated and did not cause any severe adverse effects
HSS, et al( 2013) 5.5 % patients in test groups and 11.8 % patients in placebo group experienced SAEs; All were unrelated to treatment( except for one case in Placebo group)
89.4 % and 94.1 % patients in test and placebo groups respectively experienced solicited reactions( both injection site and systemic). Injection site reactions included pain, erythema and swelling, whereas systemic reactions included malaise and headaches among others. These were reported frequently but at Grade 1 intensity and were transient
About half( 53.8 % CYD-TDV and 49 % Placebo) experienced unsolicited AEs, these were unrelated to vaccine
In general, the vaccine had a satisfactory safety profile and was well tolerated
Lanata, et al 2 SAEs were reported in
( 2012) the test group, and 5 were reported in the placebo group. None of them were considered to be related to the vaccine / intervention and all continued the study
Injection-site reactions were similar in test and placebo groups in terms of incidence
Solicited systemic reactions such as fever, malaise, and headaches occurred in comparable rates in both placebo and test groups, and were of low grade.
Unsolicited adverse effects were considered unrelated to the injections( Upper respiratory tract infections, gastrointestinal disorders, etc)
The vaccine had a good safety profile and was well tolerated in general