PMID- 21983216
OWN - NLM
STAT- MEDLINE
DCOM- 20120525
LR  - 20151119
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 30
IP  - 12
DP  - 2011 Dec
TI  - Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children 
      previously immunized with 7-valent pneumococcal conjugate vaccine.
PG  - 1086-91
LID - 10.1097/INF.0b013e3182372c6a [doi]
AB  - BACKGROUND: The 7-valent pneumococcal conjugate vaccine (PCV7) has proven highly 
      effective in preventing diseases caused by Streptococcus pneumoniae; however, in 
      some regions, serotype coverage is limited. A recently licensed 13-valent PCV 
      (PCV13) was developed to provide additional coverage globally. Children 
      previously vaccinated with PCV7 could benefit from supplemental vaccination with 
      PCV13 to provide protection against the 6 additional serotypes in PCV13. This 
      open-label study evaluated the immunogenicity and safety of administering PCV13 
      to healthy children previously vaccinated with PCV7. METHODS: Children between 15 
      months and 2 years of age (group 1) received 2 doses of PCV13; children between 2 
      and 5 years (group 2) received 1 dose. Antibodies (immunoglobulin G) against the 
      polysaccharide antigens in PCV13 were measured before vaccination and 1 month 
      after the final dose. Solicited local and systemic adverse events (AEs) were 
      collected for 7 days postvaccination. Unsolicited and serious AEs were collected 
      throughout. RESULTS: A total of 284 subjects (group 1: n = 109; group 2: n = 175) 
      had blood available for testing. Antipneumococcal immunoglobulin G geometric mean 
      fold rises ranged from 2- to 19-fold for the PCV7 serotypes and from 
      approximately 2- to 124-fold for the 6 additional serotypes. Additionally, 
      postvaccination titers in excess of 0.35 mug/mL, the serologic correlate of 
      immunity against pneumococcus for children, occurred in >/=98% of subjects in both 
      groups for 12 of the 13 serotypes in PCV13. Slightly lower percentage of 
      subjects, 94.5% and 92% of subjects in group 1 and group 2, respectively, had 
      postvaccine titers for serotype 3 exceeding the serologic correlate of immunity. 
      Reactogenicity was typically mild and self-limited, and unsolicited AEs reported 
      were generally consistent with common childhood illnesses. CONCLUSION: PCV13 was 
      safe and immunogenic when administered to children who had previously received 
      PCV7, and can be used for supplemental vaccination to provide additional 
      protection against the 6 additional serotypes.
FAU - Frenck, Robert Jr
AU  - Frenck R Jr
AD  - Cincinnati Children's Hospital Medical Center, Department of Pediatrics, 
      Cincinnati, OH 45229, USA. Robert.Frenck@cchmc.org
FAU - Thompson, Allison
AU  - Thompson A
FAU - Yeh, Sylvia H
AU  - Yeh SH
FAU - London, Arnold
AU  - London A
FAU - Sidhu, Mohinder S
AU  - Sidhu MS
FAU - Patterson, Scott
AU  - Patterson S
FAU - Gruber, William C
AU  - Gruber WC
FAU - Emini, Emilio A
AU  - Emini EA
FAU - Scott, Daniel A
AU  - Scott DA
FAU - Gurtman, Alejandra
AU  - Gurtman A
CN  - 3011 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00761631
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
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 (13-valent pneumococcal vaccine)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Heptavalent Pneumococcal Conjugate Vaccine)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Antibodies, Viral/blood
MH  - Child, Preschool
MH  - Heptavalent Pneumococcal Conjugate Vaccine
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Infant
MH  - Pneumococcal Vaccines/administration & dosage/adverse effects/*immunology
MH  - Prospective Studies
FIR - Bader, Gerald
IR  - Bader G
FIR - Frey, John
IR  - Frey J
FIR - Bryant, Kristina
IR  - Bryant K
FIR - Keathley, Susan
IR  - Keathley S
FIR - Rupp, Richard
IR  - Rupp R
FIR - Johnson, Anthony
IR  - Johnson A
FIR - Rouse, Kevin
IR  - Rouse K
FIR - Senders, Shelly
IR  - Senders S
FIR - Martin, Michael
IR  - Martin M
FIR - Sperling, Malcolm
IR  - Sperling M
FIR - Andrews, Wilson
IR  - Andrews W
FIR - Payton, Terry
IR  - Payton T
FIR - Pichichero, Michael
IR  - Pichichero M
FIR - Hurley, David
IR  - Hurley D
FIR - Rodriguez, Carina A
IR  - Rodriguez CA
FIR - Kennedy, William
IR  - Kennedy W
FIR - Goswami, Umesh
IR  - Goswami U
FIR - Rhodes, Robbie
IR  - Rhodes R
FIR - Cox, Matthew
IR  - Cox M
FIR - Harris-Ford, Laurie
IR  - Harris-Ford L
FIR - Tillisch, Janet
IR  - Tillisch J
FIR - Twogood, Todd
IR  - Twogood T
FIR - Grogg, Stanley
IR  - Grogg S
FIR - Bernstein, Henry
IR  - Bernstein H
FIR - Byington, Carrie
IR  - Byington C
FIR - Chambers, Christopher
IR  - Chambers C
FIR - Simpson, Mark
IR  - Simpson M
FIR - Benbow, Marshall
IR  - Benbow M
EDAT- 2011/10/11 06:00
MHDA- 2012/05/26 06:00
CRDT- 2011/10/11 06:00
PHST- 2011/10/11 06:00 [entrez]
PHST- 2011/10/11 06:00 [pubmed]
PHST- 2012/05/26 06:00 [medline]
AID - 10.1097/INF.0b013e3182372c6a [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.