PMID- 25741971
OWN - NLM
STAT- MEDLINE
DCOM- 20151113
LR  - 20150306
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 34
IP  - 2
DP  - 2015 Feb
TI  - Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate 
      vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate 
      vaccine.
PG  - 186-94
LID - 10.1097/INF.0000000000000516 [doi]
AB  - BACKGROUND: Widespread use of 7-valent pneumococcal conjugate vaccine (PCV7) in 
      children has led to significant reduction in pneumococcal disease in children and 
      adults. However, diseases caused by serotypes not included in PCV7 have 
      increased. A 15-valent pneumococcal conjugate vaccine (PCV15) containing 
      serotypes in PCV7 and 8 additional serotypes (1, 3, 5, 6A, 7F, 19A, 22F, 33F) was 
      developed and evaluated in toddlers 12 to 15 months of age. METHODS: Ninety 
      toddlers who completed an infant series with PCV7 received a single dose of 
      either aluminum-adjuvanted PCV15, nonadjuvanted PCV15, or PCV7. Injection-site 
      and systemic adverse events (AEs) were collected for 14 days postvaccination and 
      serious AEs (SAEs) were collected for 30 days postvaccination. Solicited AEs 
      included local (pain/tenderness, swelling, nodule and redness) and systemic 
      (fatigue, arthralgia and myalgia) AEs. Serotype-specific immunoglobulin G (IgG) 
      and opsonophagocytic (OPA) responses were measured immediately prior and 30 days 
      postvaccination. RESULTS: Incidences of local and systemic AEs were comparable 
      across vaccine groups. The majority of reported events, regardless of vaccine 
      received, were transient and of mild to moderate intensity. No clinically 
      significant differences were observed when comparing duration and severity of 
      AEs. No vaccine-related SAEs or discontinuations from the study due to AEs were 
      reported. Pneumococcal IgG concentrations and OPA titers increased 
      postvaccination, with appreciable fold rises for all serotypes. Antibody levels 
      were comparable between both PCV15 formulations and generally comparable to PCV7 
      for the shared serotypes. CONCLUSION: Both formulations of PCV15 display 
      acceptable safety profiles and induce IgG and OPA responses to all vaccine 
      serotypes.
FAU - Sobanjo-ter Meulen, Ajoke
AU  - Sobanjo-ter Meulen A
AD  - From the *Merck & Co., Inc., Whitehouse Station, NJ; daggerUniversity of Tampere, 
      Tampere, Finland; double daggerMD Research, Canton, OH; and  section signPediatric Medical Associates, 
      Rydal, PA.
FAU - Vesikari, Timo
AU  - Vesikari T
FAU - Malacaman, Edgardo A
AU  - Malacaman EA
FAU - Shapiro, Steven A
AU  - Shapiro SA
FAU - Dallas, Michael J
AU  - Dallas MJ
FAU - Hoover, Patricia A
AU  - Hoover PA
FAU - McFetridge, Richard
AU  - McFetridge R
FAU - Stek, Jon E
AU  - Stek JE
FAU - Marchese, Rocio D
AU  - Marchese RD
FAU - Hartzel, Jonathan
AU  - Hartzel J
FAU - Watson, Wendy J
AU  - Watson WJ
FAU - Musey, Luwy K
AU  - Musey LK
LA  - eng
SI  - ClinicalTrials.gov/NCT01215175
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Opsonin Proteins)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Antibodies, Bacterial/*blood
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Infant
MH  - Male
MH  - Opsonin Proteins/*blood
MH  - Phagocytosis
MH  - Pneumococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
EDAT- 2015/03/06 06:00
MHDA- 2015/11/14 06:00
CRDT- 2015/03/06 06:00
PHST- 2015/03/06 06:00 [entrez]
PHST- 2015/03/06 06:00 [pubmed]
PHST- 2015/11/14 06:00 [medline]
AID - 00006454-201502000-00016 [pii]
AID - 10.1097/INF.0000000000000516 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2015 Feb;34(2):186-94. doi: 10.1097/INF.0000000000000516.