PneuMatters: maternal immunisation to prevent pneumonia in childre
- Conditions
- Acute Lower Respiratory InfectionRespiratory - Other respiratory disorders / diseasesInfection - Other infectious diseases
- Registration Number
- ACTRN12618000150246
- Lead Sponsor
- Menzies School of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 292
(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
1.Considered to be high-risk pregnancy* by attending obstetrician
2.Receipt of any pneumococcal vaccine in the 2 years prior to randomisation
3.Contraindication or known hypersensitivity to 10vPHiD-CV as per the Australian Immunisation Handbook
4.Confirmed or suspected immunosuppressive condition or immunodeficiency disorder that can be expected to interfere with immune responses to vaccination;
5.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);
6.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;
7.Active participation in a clinical trial of another investigational drug/vaccine or interventional therapy.
8.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of medically attended acute respiratory infections in infants. Endpoint case definition of ALRI is a medically attended episode of illness defined as the presence of acute cough, dyspnoea, raised respiratory rate for age, new abnormal chest exam findings or radiographic findings for presumed respiratory illness. Clinic visits for ALRIs within 2 weeks of each other will be counted as part of the same ALRI. Outcome assessed by parent report and medical record review.[12 months of age]
- Secondary Outcome Measures
Name Time Method