학술논문
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
Document Type
article
Author
Amanda Jane Leach; Edward Kim Mulholland; Mathuram Santosham; Paul John Torzillo; Peter McIntyre; Heidi Smith-Vaughan; Nicole Wilson; Beth Arrowsmith; Jemima Beissbarth; Mark D. Chatfield; Victor M. Oguoma; Paul Licciardi; Sue Skull; Ross Andrews; Jonathan Carapetis; Joseph McDonnell; Vicki Krause; Peter Stanley Morris
Source
Vaccine: X, Vol 7, Iss , Pp 100086- (2021)
Subject
Language
English
ISSN
2590-1362
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 months (_SSS), or PHiD-CV10 at 1–2–4 plus PCV13 at −6 months (SSSP). Primary outcomes (blinded) were immunogenicity against PCV13-only serotypes 3, 6A, 19A, and PHiD-CV10-only protein D at 7 months. Secondary outcomes include immunogenicity against all serotypes at 2, 4 and 7 months. Findings: Between 2011 and 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). An intention to treat approach including all available data was used. The SSSP group had superior immunogenicity against serotypes 3, 6A, and 19A compared to _SSS (OPA GMT ratios 8.1 to 59.5, p