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Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study

key information

source: The Pediatric Infectious Disease Journal

year: 2017

authors: Sirima SB, Tiono A, Gansané Z, Siribié M, Zongo A, Ouédraogo A, François N, Strezova A, Dobbelaere K, Borys D.

summary/abstract:

BACKGROUND:
Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections.
METHODS:
In this phase III, open-label, single-center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N = 300): children 8-11 weeks of age ( RESULTS:
One month postprimary vaccination, for each vaccine serotype ≥98% of infants in the CONCLUSIONS:
PHiD-CV was immunogenic with an acceptable safety profile in children with and without SCD starting vaccination at 8 weeks to 23 months of age.

organization: Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou; Centre Hospitalier Universitaire Yalgado Ouédraogo; GSK, Wavre, Belgium; XPE Pharma & Science C/O GSK, Wavre, Belgium

DOI: 10.1097/INF.0000000000001518

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