Protecting From Pneumococcus in Early Life (The PROPEL Trial) (PROPEL)
Pneumonia
About this trial
This is an interventional prevention trial for Pneumonia focused on measuring maternal and neonatal pneumococcal conjugate vaccination, pneumococcal carriage
Eligibility Criteria
Inclusion Criteria:
- Signed/thumb-printed informed consent for trial participation obtained*
- Pregnant woman aged between 18 and 40 years of age inclusive10*
- Singleton pregnancy*
- From 28 to 34 weeks11 gestation as determined by USS
- Resident within easy reach of the clinical trial site (no fixed boundaries will be set and such judgements will be made on a case by case basis by members of the field team in discussion with the potential participant, taking into account knowledge of the local transport links and geography)*
- Intention to deliver at the health centre related to the clinical trial site (i.e. Sukuta and Faji Kunda health centres)*
- Willingness and capacity to comply with all the study procedures, including those relating to the newborn infant, in the opinion of the principal investigator or designee
Exclusion Criteria:
- History of pre-eclampsia or eclampsia
- History of gestational diabetes
- Previous late stillbirth (defined as loss of pregnancy at any time after 28 weeks gestation)
- Previous premature delivery (defined as delivery before 37 weeks gestation)
- Previous neonatal death (defined as death of an infant within the first 28 days of life)
- Previous Caesarean section
- Previous delivery of an infant with major congenital anomalies
- Previous delivery of an infant with a known or suspected genetic or chromosomal abnormality
- History of other significant pregnancy related complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected
- History of other significant neonatal complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected
- Significant complications in current pregnancy
- Significant alcohol consumption during current pregnancy
- Significant maternal chronic illness including but not limited to hypertension requiring treatment, heart disease, lung disease, neurological disorders including a history of epilepsy or recurrent afebrile seizures, kidney disease, liver disease, anaemia and other haematological disorders, endocrine disorders including known diabetes mellitus, autoimmunity
- Severe anaemia (<7.0g/dL)[51]
- Known Human Immunodeficiency Virus (HIV) or hepatitis B (HBV) virus positive or found to be HIV or HBV positive during screening
- Positive result for syphilis infection on laboratory testing
- Known prior receipt of a pneumococcal vaccine (pneumococcal conjugate or pneumococcal polysaccharide vaccine)
- Receipt of any vaccine during the current pregnancy or plans to receive any non-study vaccines during the current pregnancy (tetanus toxoid vaccination is not an exclusion and vaccines given during national campaigns if applicable will not generally be exclusions)
- Any other condition judged to significantly increase the risks to either the mother or the infant within the current (including relevant history from previous pregnancies
- History of anaphylactic or severe allergic reactions to previous vaccines or history of anaphylactic or severe allergic reactions in previous offspring (if applicable)
- Receipt of any blood product including human immunoglobulins at any stage during the current pregnancy or plan to receive any blood products during the period or trial participation (receipt or blood products in an emergency or for obstetric reasons will not represent a protocol deviation given such situations are unplanned)
- Receipt of immunosuppressive or immuno-modulatory medication at any stage during the current pregnancy or plan to receive any such medication during the period or trial participation
- Clinically suspected or confirmed congenital or acquired clotting or bleeding disorders or the current receipt of medications known to alter clotting or bleeding
- Current malaria infection (on the day of randomization and vaccination)
- Any clinically significant signs or symptoms of acute illness, significant abnormalities in vital signs, an axillary temperature of > 37.5°C or any recorded fever (> 37.5°C) in the preceding 24 hours.
- 2 or more symptoms (nausea/vomiting, diarrhoea, headaches, fatigue and myalgia) rated as grade 2 and clinically significant on the maternal systemic reactogenicity scale present at baseline on the day of vaccination
Sites / Locations
- Sukuta Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
maternal group
control group
neonatal group
13-valent pneumococcal conjugate vaccine [Prevenar13®] (PCV13) vaccine, 0.5ml, once, stat, plus tetanus toxoid to pregnant women between 28-34 weeks and their infants will get PCV13 at 8, 12 and 16 weeks according to normal EPI vaccination in country
placebo sterile 0.9% sodium chloride, 0.5ml, once, stat plus tetanus toxoid to pregnant women between 28-34 weeks and their infants will get PCV13 at 8, 12 and 16 weeks according to normal EPI vaccination in country
tetanus toxoid to pregnant women between 28-34 weeks and their infants will get PCV 13 0.5ml at birth, 8 weeks and 16 weeks