Leach AJ; Mulholland EK; Santosham M; Torzillo PJ; Brown NJ; McIntyre P; Smith-Vaughan H; Skull S; Balloch A; Andrews RM; Carapetis J; McDonnell J; Krause, Vicki; Morris, Peter

Author(s)

Leach AJ

Mulholland EK

Santosham M

Torzillo PJ

Brown NJ

McIntyre P

Smith-Vaughan H

Skull S

Balloch A

Andrews RM

Carapetis J

McDonnell J

Krause, Vicki

Morris, Peter

Publication Date

2015-01-16

Abstract

Otitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection. This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM. Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals. ACTRN12610000544077 and NCT01174849.

Citation

BMJ Open . 2015 Jan 16;5(1):e007247. doi: 10.1136/bmjopen-2014-007247.

Pubmed ID

https://pubmed.ncbi.nlm.nih.gov/25596202/?otool=iaurydwlib

Link

https://hdl.handle.net/10137/5521

Subject

IMMUNOLOGY

MICROBIOLOGY

PUBLIC HEALTH

MESH subject

Australia

Clinical Protocols

Female

Haemophilus Infections

Haemophilus influenzae

Humans

Infant

Infant, Newborn

Male

Nasopharynx

Pneumococcal Infections

Pneumococcal Vaccines

Research Design

Risk

Streptococcus pneumoniae

Vaccines, Conjugate

Immunization Schedule

Oceanic Ancestry Group

Title

Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.

Type of document

Journal Article

Entity Type

Publication

Author(s)	Leach AJ Mulholland EK Santosham M Torzillo PJ Brown NJ McIntyre P Smith-Vaughan H Skull S Balloch A Andrews RM Carapetis J McDonnell J Krause, Vicki Morris, Peter
Publication Date	2015-01-16
Abstract	Otitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection. This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM. Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals. ACTRN12610000544077 and NCT01174849.
Citation	BMJ Open . 2015 Jan 16;5(1):e007247. doi: 10.1136/bmjopen-2014-007247.
Pubmed ID	https://pubmed.ncbi.nlm.nih.gov/25596202/?otool=iaurydwlib
Link	https://hdl.handle.net/10137/5521
Subject	IMMUNOLOGY MICROBIOLOGY PUBLIC HEALTH
MESH subject	Australia Clinical Protocols Female Haemophilus Infections Haemophilus influenzae Humans Infant Infant, Newborn Male Nasopharynx Pneumococcal Infections Pneumococcal Vaccines Research Design Risk Streptococcus pneumoniae Vaccines, Conjugate Immunization Schedule Oceanic Ancestry Group
Title	Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.
Type of document	Journal Article
Entity Type	Publication

Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.

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