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Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial.

Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial.
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Madhi SA, Koen A, Jose L, Moreira M, van Niekerk N, Cutland C, François N, Ruiz-Guiñazú J, Yarzabal JP, Borys D, Schuerman L,


Madhi SA, Koen A, Jose L, Moreira M, van Niekerk N, Cutland C, François N, Ruiz-Guiñazú J, Yarzabal JP, Borys D, Schuerman L, (click to view)

Madhi SA, Koen A, Jose L, Moreira M, van Niekerk N, Cutland C, François N, Ruiz-Guiñazú J, Yarzabal JP, Borys D, Schuerman L,

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Expert review of vaccines 2017 04 20() doi 10.1080/14760584.2017.1321990

Abstract
BACKGROUND
Limited clinical data exists to assess differences between various infant pneumococcal conjugate vaccine schedules. In this trial, we evaluated immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (phid-cv) administered using 3 different immunization schedules in HIV unexposed-uninfected infants in South Africa.

RESEARCH DESIGN AND METHODS
In this phase iii, open, single-center, controlled study (clinicaltrials.gov: nct00829010), 300 infants were randomized (1:1:1) to 1 of 3 phid-cv schedules: 3-dose priming and booster (3+1); 3-dose priming without booster (3+0); or 2-dose priming and booster (2+1). the booster was administered at 9-10 months of age. immune responses were assessed up to 21 months after primary vaccination.

RESULTS
Post-priming antibody levels tended to be lower in the 2+1 group at 6 months post-priming, antibody concentrations and opsonophagocytic activity titers were within similar ranges after 2- or 3-dose priming. robust increases were observed pre- to post-booster in the 3+1 and 2+1 groups.

CONCLUSIONS
phid-cv was immunogenic when administered in different schedules. post-booster responses suggest effective immunological priming with both 2- and 3-dose primary series and support administration of the booster dose at 9-10 months of age.

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