PneuMatters: maternal immunisation to prevent pneumonia in children
A multi-centre, observer blinded, randomised controlled trial to evaluate the efficacy of the 10 valent pneumococcal-Protein D conjugate (PHiD-CV) vaccine administered during pregnancy in preventing acute lower respiratory infection (ALRI) in Australian Indigenous and Malaysian infants up to 12 months of age, compared to infants whose mothers were not vaccinated in pregnancy.
Menzies School of Health Research
292 participants
Jan 14, 2019
Interventional
Conditions
Summary
We plan a parallel, single-blind multicentre RCT (with concealed allocation) to determine the efficacy of maternal PHiD-CV immunisation on infant respiratory outcomes. Our primary question is: Does vaccinating pregnant Indigenous women with PHiD-CV (compared to controls) reduce ALRI in their infants in the first year of life? Our primary hypothesis is that: Infants born to pregnant women who received PCV-HiD have at least 30% less ALRIs in their first year of life, compared to those who did not receive the vaccine
Eligibility
Inclusion Criteria7
- (1) Infant to be identified as Aboriginal and/or Torres Strait Islander, Maori/Pacific Islander or Malaysian
- (2) Generally healthy women aged 17-40 years
- (3) Singleton pregnancy at 27 weeks (plus 6 days) to 34 weeks (plus 6 days) gestation at time of randomisation;
- (4) Treating obstetrician/medical practitioner managing the pregnancy approves participant’s enrolment in the study
- (5) Provision of written informed consent and willing and able to meet the requirements of the protocol
- (6) Planned delivery at one of the study hospitals and
- (7) Not planning to move from the study area before the infant turns 12 months of age
Exclusion Criteria9
- Considered to be high-risk pregnancy* by attending obstetrician
- Receipt of any pneumococcal vaccine in the 2 years prior to randomisation
- Contraindication or known hypersensitivity to 10vPHiD-CV as per the Australian Immunisation Handbook
- Confirmed or suspected immunosuppressive condition or immunodeficiency disorder that can be expected to interfere with immune responses to vaccination;
- Current (or within 90 days prior to receiving study vaccine) or planned (during the active study period) immunosuppressive therapy, including systemic corticosteroids (for 14 of more days in a 30-day period);
- Administration of immunoglobulins and/or blood products, with the exception of Rh Immune Globulin, within 90 days prior to receiving study vaccine, or planned administration of such products during the study period;
- Active participation in a clinical trial of another investigational drug/vaccine or interventional therapy.
- Other medical/psychosocial condition that the investigators/treating physicians consider should be excluded from the trial to prevent potential harm/risk to the subject or may adversely affect study outcomes.
- Refers to a list of high-risk conditions considered ineligible. Final decision on conditions not on the list to be made by treating obstetrician/medical practitioner.
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Interventions
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed, 1 dose of 0.5mls administered intramuscularly to pregnant women between 28 - 34 weeks gestation. The vaccine will be administered by an accredited nurse immuniser.
Locations(7)
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ACTRN12618000150246