PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
PneuMum
PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease
2 other identifiers
interventional
227
1 country
1
Brief Summary
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTpa) will be used as the control vaccine for the birth dose. The study aims to recruit 210 Indigenous women aged 17-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups. Each mother and infant will be followed from pregnancy until the baby is seven months of age. All routinely recommended vaccinations on the standard vaccination schedule will continue to be offered by the subject's vaccine provider in accordance with current clinical practice. The primary outcome will be prevalence of middle ear disease at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of one or more vaccine type pneumococci at seven months of age compared to infants in each of the other two groups. A similar comparison of the proportion with middle ear disease will be undertaken between the control group and the respective intervention group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2008
CompletedFirst Posted
Study publicly available on registry
July 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 10, 2014
July 1, 2014
4.7 years
July 10, 2008
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
at seven months of age
Nasopharyngeal carriage of vaccine type pneumococci
at seven months of age
Secondary Outcomes (9)
Prevalence of middle ear disease
at one month of age
Nasopharyngeal carriage of vaccine type pneumococci
at one month of age
Prevalence of middle ear disease
at two months of age
Nasopharyngeal carriage of vaccine type pneumococci
at two months of age
Relationship of maternal pneumococcal carriage, maternal anti-pneumococcal antibody levels, cord blood antibody levels and breast milk antibody levels to infant carriage and middle ear disease
at one, two and seven months of age
- +4 more secondary outcomes
Study Arms (3)
23vPPV in Pregnancy
ACTIVE COMPARATOR23vPPV at Birth
ACTIVE COMPARATORControl
OTHERControl
Interventions
Group A will receive 23vPPV during 3rd trimester and dTpa at delivery
Eligibility Criteria
You may qualify if:
- Singleton uncomplicated pregnancy
- Reside in Darwin, the Tiwi Islands, or other remote community where consent has been obtained
- Intends to deliver child at the Royal Darwin Hospital or other designated hospital where consent has been obtained
- Has given informed consent to participate
You may not qualify if:
- Had 23vPPV within the previous three years
- Had a previous dose of dTpa
- Intends to leave the study area during the follow-up period
- HIV positive
- History of severe allergy, uncontrolled asthma or splenectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menzies School of Health Research
Darwin, Northern Territory, 0811, Australia
Related Publications (3)
Martinovich KM, Seppanen EJ, Bleakley AS, Clark SL, Andrews RM, Richmond PC, Binks MJ, Thornton RB, Kirkham LS. Evidence of maternal transfer of antigen-specific antibodies in serum and breast milk to infants at high-risk of S. pneumoniae and H. influenzae disease. Front Immunol. 2022 Sep 21;13:1005344. doi: 10.3389/fimmu.2022.1005344. eCollection 2022.
PMID: 36211411DERIVEDBinks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Nelson J, Morris PS, Ware RS, Tang MLK, Torzillo PJ, Carapetis JR, Mulholland K, Andrews RM. Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia. Pneumonia (Nathan). 2018 Dec 25;10:13. doi: 10.1186/s41479-018-0057-2. eCollection 2018.
PMID: 30603376DERIVEDBinks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Morris PS, Nelson J, Chatfield MD, Tang ML, Torzillo P, Carapetis JR, Mulholland EK, Andrews RM. PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia. Vaccine. 2015 Nov 27;33(48):6579-87. doi: 10.1016/j.vaccine.2015.10.101. Epub 2015 Oct 31.
PMID: 26529076DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross M Andrews, PhD
Menzies School of Health Research
- PRINCIPAL INVESTIGATOR
Jonathan R Carapetis, PhD
Menzies School of Health Research
- PRINCIPAL INVESTIGATOR
Amanda J Leach, PhD
Menzies School of Health Research
- PRINCIPAL INVESTIGATOR
Peter S Morris, PhD
Menzies School of Health Research
- PRINCIPAL INVESTIGATOR
Edward K Mulholland, DM
The Univeristy of Melbourne and Murdoch Childrens Research Institute
- PRINCIPAL INVESTIGATOR
Paul J Torzillo, MBBS
Royal Prince Alfred Hospital, Sydney
- PRINCIPAL INVESTIGATOR
Mimi LK Tang, PhD
Royal Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
June 1, 2006
Primary Completion
February 1, 2011
Study Completion
July 1, 2011
Last Updated
July 10, 2014
Record last verified: 2014-07