PMID- 22112189
OWN - NLM
STAT- MEDLINE
DCOM- 20120531
LR  - 20211021
IS  - 1471-2458 (Electronic)
IS  - 1471-2458 (Linking)
VI  - 11
DP  - 2011 Nov 23
TI  - Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus 
      influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: 
      a randomized controlled trial.
PG  - 882
LID - 10.1186/1471-2458-11-882 [doi]
AB  - BACKGROUND: Pneumonia is still the leading cause of death among children in 
      Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African 
      children with invasive pneumococcal disease below the age of 5 years. The 
      immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 
      10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate 
      vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria. METHODS: In an 
      open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV 
      primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV 
      co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses 
      and opsonophagocytic activity (OPA) were measured and adverse events (AEs) 
      recorded. RESULTS: One month post-dose 3, >/= 97.2% of PHiD-CV-vaccinated infants 
      had an antibody concentration >/= 0.2 mug/mL for each vaccine pneumococcal serotype 
      except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except 
      for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, >/= 93.3% of 
      PHiD-CV recipients had an OPA titre >/= 8, except for serotypes 1 (87.6%) and 6B 
      (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 
      9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations 
      were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. 
      Overall incidences of solicited and unsolicited AEs were similar between groups. 
      CONCLUSIONS: In sub-Saharan African infants, PHiD-CV was immunogenic for all 
      vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally 
      comparable between the PHiD-CV and control groups. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier: NCT00678301.
FAU - Dicko, Alassane
AU  - Dicko A
AD  - Malaria Research and Training Center, Faculty of Medicine, Pharmacy and 
      Dentistry, University of Bamako, P,O, Box 1805, Bamako, Mali. adicko@mrtcbko.org
FAU - Odusanya, Olumuyiwa O
AU  - Odusanya OO
FAU - Diallo, Abdoulbaki I
AU  - Diallo AI
FAU - Santara, Gaoussou
AU  - Santara G
FAU - Barry, Amadou
AU  - Barry A
FAU - Dolo, Amagana
AU  - Dolo A
FAU - Diallo, Aminata
AU  - Diallo A
FAU - Kuyinu, Yetunde A
AU  - Kuyinu YA
FAU - Kehinde, Omolara A
AU  - Kehinde OA
FAU - Francois, Nancy
AU  - Francois N
FAU - Borys, Dorota
AU  - Borys D
FAU - Yarzabal, Juan P
AU  - Yarzabal JP
FAU - Moreira, Marta
AU  - Moreira M
FAU - Schuerman, Lode
AU  - Schuerman L
LA  - eng
SI  - ClinicalTrials.gov/NCT00678301
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111123
PL  - England
TA  - BMC Public Health
JT  - BMC public health
JID - 100968562
RN  - 0 (10-valent pneumococcal vaccine)
RN  - 0 (Bacterial Proteins)
RN  - 0 (Carrier Proteins)
RN  - 0 (Immunoglobulin D)
RN  - 0 (Lipoproteins)
RN  - 0 (Pneumococcal Vaccines)
RN  - EC 3.1.4.46 (glpQ protein, Haemophilus influenzae)
SB  - IM
MH  - Africa South of the Sahara
MH  - Bacterial Proteins/drug effects/*immunology
MH  - Carrier Proteins/drug effects/*immunology
MH  - Female
MH  - Haemophilus Infections/*prevention & control
MH  - Haemophilus influenzae/drug effects/*immunology
MH  - Humans
MH  - Immunoglobulin D/drug effects/*immunology
MH  - Infant
MH  - Lipoproteins/drug effects/*immunology
MH  - Male
MH  - Mali
MH  - Nigeria
MH  - Pneumococcal Vaccines/administration & dosage/pharmacology/*therapeutic use
MH  - *Primary Prevention
PMC - PMC3267728
EDAT- 2011/11/25 06:00
MHDA- 2012/06/01 06:00
PMCR- 2011/11/23
CRDT- 2011/11/25 06:00
PHST- 2011/07/20 00:00 [received]
PHST- 2011/11/23 00:00 [accepted]
PHST- 2011/11/25 06:00 [entrez]
PHST- 2011/11/25 06:00 [pubmed]
PHST- 2012/06/01 06:00 [medline]
PHST- 2011/11/23 00:00 [pmc-release]
AID - 1471-2458-11-882 [pii]
AID - 10.1186/1471-2458-11-882 [doi]
PST - epublish
SO  - BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.