title: Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries.
abstract: BACKGROUND
  Meta-analyses enable summarization and interpretation of data across clinical trials. When applied to safety data they allow for detection of rare events. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) was approved in multiple countries worldwide for routine immunization of infants and young children. This meta-analysis was conducted to identify potentially clinically important rare safety events associated with PCV13.
  
  
  OBJECTIVE
  To summarize the safety of PCV13 compared with 7-valent pneumococcal conjugate vaccine (PCV7) administered to infants and toddlers.
  
  
  METHODS
  A meta-analysis was performed of integrated safety data from 13 infant studies (PCV13 n=4729 and PCV7 n=2760) conducted in 9 North American, European, and Asian countries. Local reactions at the vaccine injection site and systemic events were collected for 4-7 days after each dose into electronic diaries. Adverse events (AEs) were collected after each vaccination.
  
  
  RESULTS
  Overall, rates of local reactions after any dose of the infant series were similar between PCV13 and PCV7 groups: tenderness (46.7% vs 44.8%, respectively); swelling (28.5% vs 26.9%); and redness (36.4% vs 33.9%). After the toddler dose, tenderness was significantly higher among PCV7 subjects than PCV13 subjects (54.4% vs 48.8%; P=0.005). Frequencies of fever (≥38°C) were similar in both groups and mostly mild (≤39°C); incidence of moderate fever (>39°C to ≤40°C) with PCV13 was ≤2.8% after any infant dose and 5.0% after the toddler dose, compared with ≤2.6% and 7.3%, respectively, with PCV7. Fever >40°C was uncommon in both groups. Frequencies of decreased appetite, irritability, and sleep disturbances were similar in both groups. AEs were the types of conditions and symptoms expected in infants and children, and clinically significant differences between vaccine groups were not observed.
  
  
  CONCLUSIONS
  PCV13 has a favorable safety profile similar to that of PCV7, a vaccine for which there is >10 years clinical experience.
authors: Pfizer Vaccines Research, 401 North Middletown Road, Pearl River, NY, USA. Electronic address: Allison.thompson@pfizer.com.
authors: Allison
authors: A
authors: Thompson
authors: Alejandra
authors: A
authors: Gurtman
authors: Scott
authors: S
authors: Patterson
authors: Christine
authors: C
authors: Juergens
authors: France
authors: F
authors: Laudat
authors: Emilio A
authors: EA
authors: Emini
authors: William C
authors: WC
authors: Gruber
authors: Daniel A
authors: DA
authors: Scott
mesh_terms: D001208:Asia; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005060:Europe; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D009656:North America; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C538862:13-valent pneumococcal vaccine; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate
keywords: 13-Valent pneumococcal conjugate vaccine; Adverse events; Meta-analysis; Safety; Vaccination