PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease
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|ClinicalTrials.gov Identifier: NCT00310349|
Recruitment Status : Unknown
Verified March 2006 by University of Melbourne.
Recruitment status was: Not yet recruiting
First Posted : April 3, 2006
Last Update Posted : December 13, 2007
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 18-39 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. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule.
The primary outcome will be prevalence of ear infection 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 vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.
|Condition or disease||Intervention/treatment||Phase|
|Middle Ear Effusion Tympanic Membrane Perforation Acute Otitis Media Pneumococcal Infections||Biological: 23 valent pneumococcal polysaccharide vaccine||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease|
|Study Start Date :||March 2006|
|Estimated Study Completion Date :||January 2009|
- Prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
- Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at seven months of age ]
- Prevalence of ear infection [ Time Frame: at one month of age ]
- Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at one month of age ]
- Prevalence of ear infection [ Time Frame: at two months of age ]
- Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: 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 [ Time Frame: at one, two and seven months of age ]
- Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine
- Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes)
- Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV
- Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels [ Time Frame: at seven months of age (following the 3rd recommended dose of 7vPCV) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310349
|Contact: Ross M Andrews, PhD||613 9345 firstname.lastname@example.org|
|Contact: Amanda J Leach, PhD||618 8922 email@example.com|
|Australia, Northern Territory|
|Menzies School of Health Research||Not yet recruiting|
|Darwin, Northern Territory, Australia, 0811|
|Contact: Amanda J Leach, PhD 618 8922 8698 firstname.lastname@example.org|
|Contact: Peter S Morris, PhD 618 89228371 email@example.com|
|Principal Investigator: Amanda J Leach, PhD|
|Principal Investigator: Peter S Morris, PhD|
|Sub-Investigator: Simone Raye, MBBS|
|Principal Investigator:||Ross M Andrews, PhD||The University of Melbourne and Murdoch Childrens Research Institute|
|Principal Investigator:||Jonathan R Carapetis, PhD||The University of Melbourne and Murdoch Childrens Research Institute|
|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|