13-Valent Pneumococcal Conjugate Vaccine Proves Favorable Safety Profile
SAN DIEGO, CA— PCV 13, a 13-valent pneumococcal conjugate vaccine, showed a favorable safety profile and immunogenicity when administered concomitantly with DTaP, reported Takehiro Togashi, MD, PhD, from Sapporo City University School of Nursing, Hokkaido, Japan, at IDWeek 2012.
Dr. Togashi and colleagues compared the immunogenicity, safety, and tolerability of PCV13 and PCV7, given concomitantly with DTaP vs. DTaP alone in Japanese infants. A total of 551 healthy infants were enrolled and received blinded PCV13 or PCV7 (with DTaP) subcutaneously at age 3–6 months, followed by two additional infant doses. The latter two doses were given at least four weeks and up to eight weeks after the previous administration. Serotype-specific immunoglobulin G (IgG) concentrations were measured one month after Dose 3 and the toddler dose (given at age 12–15 months).
For all seven serotypes common to PCV7 and PCV13, the proportion of subjects with serotype-specific IgG concentrations ≥0.35mcg/mL (e.g., responders), was non-inferior in the PCV13 + DTaP group compared with the PCV7 + DTaP group. For all six additional serotypes, the proportions of responders were non-inferior in the PCV13 + DTaP group compared with the PCV7 + DTaP group reference value, and were statistically significantly higher in the PCV13 + DTaP group compared with the PCV7 + DTaP group, they found.
From the post-infant series to the post-toddler dose, IgG GMCs were increased for most serotypes, with the exception of serotype 3 in the PCV13 + DTaP group.
Dr. Togashi noted that PCV13 + DTaP showed a favorable safety profile and was immunogenic when administered to infants. The team noted that there were no clear differences in immune response to DTaP in the PCV13 + DTaP group compared with the DTaP group, “and most or all subjects achieve the prespecified antibody levels for each antigen.”
“PCV13 was well tolerated and had a favorable safety profile when administered subcutaneously with concomitant DTaP,” he concluded.