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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00714064




Registration number
NCT00714064
Ethics application status
Date submitted
10/07/2008
Date registered
14/07/2008
Date last updated
10/07/2014

Titles & IDs
Public title
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
Scientific title
PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease
Secondary ID [1] 0 0
NHMRC 350499
Secondary ID [2] 0 0
NHMRC 490320
Universal Trial Number (UTN)
Trial acronym
PneuMum
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Middle Ear Effusion 0 0
Tympanic Membrane Perforation 0 0
Acute Otitis Media 0 0
Pneumococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Ear 0 0 0 0
Other ear disorders
Infection 0 0 0 0
Studies of infection and infectious agents
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 23vPPV, dTpa (Pneumovax, Boostrix)
Other interventions - 23vPPV, dTpa (Pneumovax, Boostrix)
Other interventions - 23vPPV, dTpa (Pneumovax, Boostrix)

Active Comparator: 23vPPV in Pregnancy -

Active Comparator: 23vPPV at Birth -

Other: Control - Control


Other interventions: 23vPPV, dTpa (Pneumovax, Boostrix)
Group A will receive 23vPPV during 3rd trimester and dTpa at delivery

Other interventions: 23vPPV, dTpa (Pneumovax, Boostrix)
Group B will receive 23vPPV at delivery and dTpa 7 months following delivery

Other interventions: 23vPPV, dTpa (Pneumovax, Boostrix)
Group C will receive dTpa at delivery and 23vPPV 7 months following delivery
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
Timepoint [1] 0 0
at seven months of age
Primary outcome [2] 0 0
Nasopharyngeal carriage of vaccine type pneumococci
Timepoint [2] 0 0
at seven months of age
Secondary outcome [1] 0 0
Prevalence of middle ear disease
Timepoint [1] 0 0
at one month of age
Secondary outcome [2] 0 0
Nasopharyngeal carriage of vaccine type pneumococci
Timepoint [2] 0 0
at one month of age
Secondary outcome [3] 0 0
Prevalence of middle ear disease
Timepoint [3] 0 0
at two months of age
Secondary outcome [4] 0 0
Nasopharyngeal carriage of vaccine type pneumococci
Timepoint [4] 0 0
at two months of age
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
at one, two and seven months of age
Secondary outcome [6] 0 0
Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine
Timepoint [6] 0 0
at seven months
Secondary outcome [7] 0 0
Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes)
Timepoint [7] 0 0
at seven months
Secondary outcome [8] 0 0
Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV
Timepoint [8] 0 0
at seven months
Secondary outcome [9] 0 0
Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels (following the 3rd recommended dose of 7vPCV)
Timepoint [9] 0 0
at seven months of age

Eligibility
Key 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
Minimum age
17 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
227
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0811 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00714064
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross M Andrews, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00714064