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The malaria vaccine full-dose group had the most general solicited signs and symptoms during the 8-d post-immunization periods, with 14, 15 and 10 general adverse events following the first, second and third immunizations, respectively, compared to 18, 4 and 6 in the half-dose group and 2, 14 and 3 in the rabies vaccine group (Table 2).
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General solicited symptoms included fatigue (most common, reported by 71% of subjects overall) followed by muscle aches (70% overall) and headache (51% overall).
General solicited symptoms were considerably less frequent, with loss of appetite observed most frequently, after 44 (17%) doses of RTS,S/AS01E and 46 (18%) of RTS,S/AS02D doses.
The most prevalent general symptoms solicited were irritability and fever (Figure 5A).
Analysis per subject showed that fever was the most frequently observed solicited general symptom for DTPw-HBV/Hib2.5 [Kft] (80.2%) and DTPw-HBV/Hib2.5 (76.0%) subjects, while irritability was the most frequently observed solicited general symptom for DTPw-HBV/Hib (64.2%).
This one is the most general".
The most common solicited local reaction was injection-site tenderness, and the most common solicited systemic reactions were irritability and abnormal crying.
In the PHiD-CV group, the most common grade 3 solicited general symptom was irritability, which was reported following 1.9% of overall doses and was considered causally related to vaccination following 1.7% of overall doses.
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Grade 3 general reactions (solicited or unsolicited) were defined as those that prevented normal daily activity, or in the case of fever an oral temperature >39.0°C.
The most frequently reported grade 3 solicited general symptom in the infants who received PHiD-CV co-administered with DTPa-HBV-IPV/Hib was irritability, which was reported following 1.9%95%5% CI: 0.9, 3.4) of doses.
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