Pneumococcal Infections Clinical Trial
— PneuMumOfficial title:
PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease
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.
Status | Completed |
Enrollment | 227 |
Est. completion date | July 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 17 Years to 39 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Menzies School of Health Research | Darwin | Northern Territory |
Lead Sponsor | Collaborator |
---|---|
Menzies School of Health Research | National Health and Medical Research Council, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media | at seven months of age | Yes | |
Primary | Nasopharyngeal carriage of vaccine type pneumococci | at seven months of age | Yes | |
Secondary | Prevalence of middle ear disease | at one month of age | Yes | |
Secondary | Nasopharyngeal carriage of vaccine type pneumococci | at one month of age | Yes | |
Secondary | Prevalence of middle ear disease | at two months of age | Yes | |
Secondary | Nasopharyngeal carriage of vaccine type pneumococci | at two months of age | Yes | |
Secondary | 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 | Yes | |
Secondary | Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine | at seven months | Yes | |
Secondary | Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes) | at seven months | Yes | |
Secondary | Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV | at seven months | Yes | |
Secondary | Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels (following the 3rd recommended dose of 7vPCV) | at seven months of age | Yes |
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