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 Research0 个研究点目标入组 292 人开始时间: 2018年2月1日最近更新: 2022年2月21日

适应症

试验速览

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•(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.

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