Protecting From Pneumococcus in Early Life (The PROPEL Trial)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02628886
• Date of registration: 07/12/2015
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Protecting From Pneumococcus in Early Life (The PROPEL Trial) PROPEL
• Scientific title: A Randomized, Controlled, Double-blind, Phase 3 Trial to Evaluate the Effects of Maternal or Neonatal Pneumococcal Conjugate Vaccination on Pneumococcal Carriage in Infants up to Nine Months of Age - The PROPEL Trial
• Date of first enrolment: March 11, 2016
• Target sample size: 600
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02628886
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Gambia

Contacts

• Name: Ed Clarke, MB
• Affiliation: Medical Research Council Unit, The Gambia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Other: tetanus toxoid

Biological: 13-valent pneumococcal conjugate vaccine [Prevenar13®] plus tetanus toxoid

Biological: placebo 0.9% sodium chloride plus tetanus toxoid

Primary Outcome(s)

safety in vaccinated newborns (local and systemic reactogenicity) [Time Frame: within the first seven days from vaccination]

cumulative carriage acquisition rate in infants [Time Frame: from birth to 20 weeks of age]

outcome of pregnancy [Time Frame: from 28 weeks of gestation to delivery]

safety in pregnant mothers (SAE) [Time Frame: from 28 weeks gestation to 8 weeks after delivery]

safety in vaccinated pregnant women (local and systemic reactogenicity) [Time Frame: within the first seven days from vaccination]

safety in newborns (SAE) [Time Frame: from birth until nine months of age]

Secondary Outcome(s)

opsonophagocytic antibodies titres in infants [Time Frame: at birth, 8 & 20 weeks of age]

pneumococcal nasopharyngeal carriage rate of pregnant women [Time Frame: at delivery and at 8 weeks after delivery]

diptheria toxoid GMC sero protection rate [Time Frame: at birth, 8 & 20 weeks of age]

nasopharyngeal carriage rate of infants [Time Frame: form birth up to nine months of age]

pneumococcal vaccine type specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) and sero protection rates in mothers and infants [Time Frame: at delivery and 8 weeks post delivery for the mothers and for the infants at birth, 8 weeks, 20 weeks and 9 months]

polio virus type 1,2,3, Geometric Mean Titre (GMT) and hepatitis B GMC sero protection rate in infants [Time Frame: at 8 weeks of age]

tetanus toxoid GMC sero protection rate in mothers [Time Frame: at birth]

Secondary ID(s)

SCC 1433

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BUGS Bioscience London Bioscience Innovation Centre 2 Royal College Street London

WHO Pneumococcal Serology Reference Laboratory Institute of Child Health