Objective: Safety and reactogenicity of a new heptavalent DTPw-HBV/Hib-MenAC (diphtheria, tetanus, whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C) vaccine was compared with a widely used pentavalent DTPw-HBV/Hib vaccine. Methods: Three phase III randomized studies comparable in design and methodology, in which healthy infants received DTPw-HBV/Hib-MenAC (N = 1334) or DTPw-HBV/Hib (N = 446) at 2, 4, and 6 months, were pooled for analysis. Solicited symptoms were recorded for 4 days, and unsolicited adverse events for 31 days after each dose. Serious adverse events (SAEs) were recorded throughout the studies. Results: There were no significant differences between the two groups in the proportion of subjects with fever >39.5 °C or >40.0 °C (p < 0.005). Compared to group DTPw-HBV/Hib, a significantly higher percentage of subjects in group DTPw-HBV/Hib-MenAC reported fever >39 °C (21.2% vs. 14.8%, p = 0.004). Fever subsided quickly, did not lead to differences in attendance to medical services and did not increase from dose to dose. Sixty-seven SAEs were reported, 56/1334 (4.2%) in group DTPw-HBV/Hib-MenAC and 11/446 (2.5%) in the DTPw-HBV/Hib group. Conclusion: Overall, the heptavalent and pentavalent vaccines had similar safety profiles. The difference observed in percentage of subjects with fever >39 °C did not lead to differences in medically attended visits for fever. © 2007.
Kerdpanich, A., Warachit, B., Kosuwon, P., Gatchalian, S. R., Watanaveeradej, V., Borkird, T., … Dobbelaere, K. (2008). Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. International Journal of Infectious Diseases, 12(1), 88–97. https://doi.org/10.1016/j.ijid.2007.06.002