Files and links (1)
Published VersionCC BY V4.0, Open Access
Journal article
Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial
BMC Pediatrics, Vol.21(1), pp.1-14
2021
PMID: 33685411
Abstract
Background: Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix (TM) (PHiD-CV10, with protein D of NTHi) and Prevenar13 (TM) (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months.
Methods: In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13 (TM) (P) at 2-4-6 months (_PPP), Synflorix (TM) (S) at 2-4-6 months (_SSS), or Synflorix (TM) at 1-2-4 months plus Prevenar13 (TM) at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM).
Results: Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM.
Conclusions: Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life.
Details
- Title
- Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial
- Authors
- Amanda Jane Leach (Corresponding Author) - Menzies School of Health ResearchEdward Kim Mulholland - The University of MelbourneMathuram Santosham - Johns Hopkins UniversityPaul J. Torzillo - Royal Prince Alfred HospitalPeter B McIntyre - National Centre for Immunisation Research & SurveillanceHeidi C Smith-Vaughan - Charles Darwin UniversityNicole Wilson - Menzies School of Health ResearchBeth Arrowsmith - Menzies School of Health ResearchJemima Beissbarth - Menzies School of Health ResearchMark D Chatfield - Charles Darwin UniversityVictor Oguoma - Charles Darwin UniversityPeter Stanley Morris - Charles Darwin University
- Publication details
- BMC Pediatrics, Vol.21(1), pp.1-14
- Publisher
- BioMed Central Ltd.
- Date published
- 2021
- DOI
- 10.1186/s12887-021-02552-z
- ISSN
- 1471-2431
- PMID
- 33685411
- Copyright note
- This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
- Data Availability
- The datasets generated and/or analysed during the current study are not publicly available due participant confidentiality but are available from the corresponding author on reasonable request.
- Grants
- Grant note
- Financial Markets for Children (Grant number 2012–057).
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991121852102621
- Output Type
- Journal article
Metrics
5 Record Views
InCites Highlights
These are selected metrics from InCites Benchmarking & Analytics tool, related to this output
- Collaboration types
- Domestic collaboration
- International collaboration
- Web Of Science research areas
- Pediatrics
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites