PMID- 23291945
OWN - NLM
STAT- MEDLINE
DCOM- 20141224
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 9
IP  - 2
DP  - 2013 Feb
TI  - Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent 
      pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine 
      (PHiD-CV) in Malian children.
PG  - 382-8
LID - 22692 [pii]
AB  - BACKGROUND: Primary vaccination with the 10-valent pneumococcal non-typeable 
      Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was previously shown 
      to be immunogenic and well tolerated in Malian children. Data on booster 
      vaccination with a fourth consecutive dose of PHiD-CV are available for Europe, 
      Asia and Latin America but are lacking for Africa. The present study evaluated 
      further the safety, reactogenicity and immunogenicity of a fourth consecutive 
      (booster) dose of PHiD-CV. RESULTS: Low incidences of AEs with grade 3 intensity 
      (2.1% of subjects) were observed. There were no reports of large swelling 
      reactions and serious adverse events. One month post-booster vaccination, for 
      each vaccine pneumococcal serotype, at least 97.8% of subjects had antibody 
      concentrations >/= 0.2 mug/ml, and at least 97.1% of subjects had opsonophagocytic 
      activity >/= 8. From pre- to post-booster, a 12.3-fold increase in anti-protein D 
      geometric mean concentration was observed. METHODS: This phase III, open-label 
      study was conducted in Ouelessebougou, Mali, between November 2009 and June 2010. 
      The study population consisted of Malian children previously primed (3 doses) 
      with PHiD-CV in study NCT00678301 receiving a fourth consecutive (booster) dose 
      of PHiD-CV in the second year of life. The incidences of adverse events (AEs) 
      with grade 3 intensity (primary objective) or of any intensity (secondary 
      objective), and the immunogenicity (secondary objective) of the PHiD-CV booster 
      dose were assessed. CONCLUSION: A booster dose of PHiD-CV was well tolerated when 
      administered to Malian children in the second year of life and was highly 
      immunogenic for all 10 vaccine pneumococcal serotypes and NTHi protein D. 
      (ClinicalTrials.gov identifier: NCT00985465).
FAU - Dicko, Alassane
AU  - Dicko A
AD  - Malaria Research and Training Centre; Faculty of Medicine; Pharmacy and 
      Dentistry; University of Bamako; Bamako, Mali; Department of Public Health; 
      Faculty of Medicine; Pharmacy and Dentistry; University of Bamako; Bamako, Mali.
FAU - Santara, Gaoussou
AU  - Santara G
FAU - Mahamar, Almahamoudou
AU  - Mahamar A
FAU - Sidibe, Youssoufa
AU  - Sidibe Y
FAU - Barry, Amadou
AU  - Barry A
FAU - Dicko, Yahia
AU  - Dicko Y
FAU - Diallo, Aminata
AU  - Diallo A
FAU - Dolo, Amagana
AU  - Dolo A
FAU - Doumbo, Ogobara
AU  - Doumbo O
FAU - Shafi, Fakrudeen
AU  - Shafi F
FAU - Francois, Nancy
AU  - Francois N
FAU - Strezova, Ana
AU  - Strezova A
FAU - Borys, Dorota
AU  - Borys D
FAU - Schuerman, Lode
AU  - Schuerman L
LA  - eng
SI  - ClinicalTrials.gov/NCT00985465
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20130104
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (10-valent pneumococcal conjugate vaccine)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Opsonin Proteins)
RN  - 0 (PHiD-CV vaccine)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Antibodies, Bacterial/blood
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Haemophilus Infections/*prevention & control
MH  - Humans
MH  - Immunization, Secondary/*adverse effects/*methods
MH  - Incidence
MH  - Infant
MH  - Male
MH  - Mali
MH  - Opsonin Proteins/blood
MH  - Phagocytosis
MH  - Pneumococcal Vaccines/administration & dosage/*adverse effects/*immunology
PMC - PMC3859761
OTO - NOTNLM
OT  - Mali
OT  - PHiD-CV
OT  - antibody persistence
OT  - booster
OT  - immunogenicity
OT  - pneumococcal conjugate vaccine
OT  - reactogenicity
OT  - safety
EDAT- 2013/01/08 06:00
MHDA- 2014/12/30 06:00
PMCR- 2013/01/04
CRDT- 2013/01/08 06:00
PHST- 2013/01/08 06:00 [entrez]
PHST- 2013/01/08 06:00 [pubmed]
PHST- 2014/12/30 06:00 [medline]
PHST- 2013/01/04 00:00 [pmc-release]
AID - 22692 [pii]
AID - 2012HV0216R [pii]
AID - 10.4161/hv.22692 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2013 Feb;9(2):382-8. doi: 10.4161/hv.22692. Epub 2013 Jan 
      4.