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13-Valent Pneumococcal Conjugate Vaccine as Safe as 7-Valent Vaccine for Infants, Toddlers: Presented at ESPID By Jenny Powers NICE, France -- May 11, 2010 -- A 13-valent pneumococcal conjugate vaccine (PCV13) has a similar safety profile to a 7-valent pneumococcal conjugate vaccine (PCV7) in infants aged 6 to 8 weeks and in toddlers, researchers said here at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Alejandro Gurtmen, MD, Pfizer, Pearl River, New York, presented a meta-analysis of 13 clinical trials conducted in 9 countries here on May 7. In the studies, PCV13 was administered to 4,729 healthy infants and toddlers and 2,760 received PCV7. Local reactions at the injection site and systemic events were collected for 4 to 7 days after each dose into electronic diaries. Unsolicited adverse events (AEs) were collected after each vaccination. The results showed comparable rates of local injection site reactions following infant vaccination with PCV13 or PCV7. These included tenderness (46.7% vs 44.8%), swelling (28.5% vs 26.9%), and redness (36.4% vs 33.9%). After the toddler dose, tenderness was significantly lower (P = .005) in the PCV13 group than the PCV7 group. Frequencies of fever were similar in both groups and most were mild. Incidence of moderate fever with PCV13 was <=2.8% after any infant dose and 5% after the toddler dose compared with <=2.6% and 7.3% with PCV7. Severe fever was uncommon in both groups. Comparable frequencies of decreased appetite, irritability, and sleep disturbances were reported in both groups. A total of 22 subjects (0.47%) in the PCV13 group discontinued study vaccine because of AEs and 17 subjects (0.62%) in the PCV7 group. Funding for this study was provided by Pfizer. [Presentation title: Safety or 13-Valent Pneumococcal Conjugate Vaccine in Infants and Children: Meta-Analysis of 13 Clinical Trials in 9 Countries. Abstract 516] E-mail this page to a friend or colleague! To print, use this version