Interchangeability, immunogenicity and safety of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (Synflorix) and 13-valent-PCV (Prevenar13) schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

AJ Leach; EK Mulholland; M Santosham; PJ Torzillo; P McIntyre; H Smith-Vaughan; N Wilson; B Arrowsmith; J Beissbarth; MD Chatfield; VM Oguoma; P Licciardi; S Skull; R Andrews; J Carapetis; J McDonnell; V Krause; PS Morris

Journal article

Interchangeability, immunogenicity and safety of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (Synflorix) and 13-valent-PCV (Prevenar13) schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

AJ Leach, EK Mulholland, M Santosham, PJ Torzillo, P McIntyre, H Smith-Vaughan, N Wilson, B Arrowsmith, J Beissbarth, MD Chatfield, VM Oguoma, P Licciardi, S Skull, R Andrews, J Carapetis, J McDonnell, V Krause, PS Morris

Vaccine X | Published : 2021

DOI: 10.1016/j.jvacx.2021.100086

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Abstract

Background: Aboriginal children living in remote communities are at high risk of early and persistent otitis media. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are primary pathogens. Vaccines with potential to prevent early OM have not been evaluated in this population. We compared immunogenicity (ELISA and opsonophagocytic activity) of a combination of Synflorix™ (PHiD-CV10, 10 serotypes and protein D of NTHi) and Prevenar13™ (PCV13, 10 serotypes plus 3, 6A, and 19A), with recommended schedules. Methods: This open-label superiority trial randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to PCV13 (P) at 2–4-6 months (_PPP), PHiD-CV10 (S) at 2–4-6 mont..

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