A Phase 3 interventional study of 13-valent pneumococcal conjugate vaccine [Prevenar13®] plus tetanus toxoid and placebo 0.9% sodium chloride plus tetanus toxoid in Pneumonia, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Gambia. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Prevention
Streptococcus pneumoniae is responsible for over 10 percent of death in children under five and many of these deaths occur in early infancy before the current pneumococcal schedule is effective and nearly half occur in sub Saharan Africa.
The PROPEL trial will examine the effect of either a maternal or a neonatal dose of a pneumococcal conjugate vaccine on pneumococcal colonisation in the nose which can be used to measure the risk of disease in early life.
600 Expectant mothers will be randomized at between 28 and 34 weeks to a maternal group, a neonatal group or a control group in equal number (200 per group). Their subsequent born offspring will be followed up until nine months of age. Infants born from expectant mothers in the maternal and control group will receive their subsequent pneumococcal conjugate vaccination according to the national Expanded Programme on Immunisation (EPI) schedule in the Gambia at 8, 12 and 16 weeks while infants born to expectant mothers in the control group will receive the pneumococcal conjugate vaccine within 48 hours of birth and at 8 and 16 weeks of life. Randomization will be undertaken by defined un-blinded members of the clinical trial team who will be delegated for this task and who will not be involved in any other trial related procedures Pregnant women who are willing and who are identified by the staff of the government antenatal clinic as being potentially eligible according to gestation (assessed initially according to the date of the last menstrual period (LMP) - if known, or the fundal height), will be referred to a member of the clinical trial team.
Those who remain interested in participation having had the details of the study explained will have basic demographic, obstetric and contact details collected and will be invited, at a time of their convenience, to the Medical Research Council (MRC) clinical trial site for the formal informed consent process to be completed. Following informed consent, pregnancy will be confirmed with a urinary pregnancy test. Initial screening (e.g. for past-obstetric history and past-medical history etc) will be undertaken at this point along with screening bloods for serology (HIV, hepatitis B and syphilis) and haematology (haemoglobin and sickle test). A dating ultrasound scan (USS) will also be undertaken by designated clinical trial staff. On completion of screening, expectant mothers who are confirmed to be eligible according to the defined inclusion and exclusion criteria will be enrolled and randomized in parallel into one of three equally sized groups mentioned above (maternal, neonatal, control).
According to the group into which they have been randomized, mothers will receive a dose of PCV13 and tetanus toxoid [maternal group], placebo (0.9% sodium chloride) and tetanus toxoid [control group] or tetanus toxoid alone [neonatal group]. From this point on, the maternal and control groups (now 'Routine EPI Schedule') will be followed up in exactly the same way for the purposes of interventions and all endpoint assessments. Infants in the neonatal group ('Neonatal Schedule') will be followed up according to the schedule outlined.
At the time of presentation to the delivery unit a blood sample for serology and malaria Rapid Diagnostic Test (RDT) and an nasopharyngeal swab (NPS) sample will be obtained prior to or shortly following delivery. Immediately following delivery a sample of cord blood will be obtained and as soon as possible an NPS sample will be taken from the newborn. Anthropometric measurements will be taken from the newborn and an examination conducted. Once there has not been any contraindication to vaccination identified, all newborns will be administered the routine EPI vaccines according to the schedule in The Gambia (BCG, Hepatitis B and OPV). Those newborns in the Neonatal group will additionally be administered a single intramuscular (IM) dose of PCV13. At two, three and four months, infants will be administered the routine EPI vaccines. Those infants in the Maternal and Control Groups (Routine EPI Schedule) will additionally receive PCV13 at eight, 12, and 16 weeks while those in the Neonatal group will receive the vaccine at eight and 16 weeks only having received the first dose at birth. All infants will additionally receive a single dose of the inactivated poliovirus vaccine (IPV) at 16 weeks in line with the routine EPI schedule in The Gambia.
Following the vaccines administered to expectant mothers and following the vaccines administered at birth, home visits will be undertaken on day 1 to 6 to collect solicited local and systemic adverse (for PCV only) reactions and any unsolicited. A day 7 safety clinic visit will be conducted following the vaccines administered to expectant mothers and following the vaccines administered at birth. Infant will attend the clinical trial site for NPS and blood samples to be taken at specific time points.
Members of the clinical trial team will base themselves within the government run antenatal clinics at the clinical trial sites in order to identify potentially eligible pregnant women. Working closely alongside government midwifery and nursing staff they will aim to identify pregnant women who are yet to reach 34 weeks gestation and who are thus potentially eligible for enrolment. Assessment of gestation at this first contact point will be based on the date of the LMP or the assessment of fundal height as is local practice (gestational age will be confirmed by ultrasound scanning once informed consent has been obtained and ultrasound based assessment will be used to determine final eligibility).
A member of the clinical trial team will discuss the study with potentially eligible expectant mothers who are provisionally interested and agree to receive this additional information. The discussion will be based on the contents of the informed consent document (ICD) and a copy of the ICD will be provided to the expectant mother at the end of the discussion.
Potentially eligible women who are interested will be encouraged to discuss the study with their spouse and other family members as appropriate. Following individual sensitization of the mother, a member of the field team may provide information to other family members (particularly the spouse) either by telephone or through a visit to the subject's residence according to the preference of the mother.
Expectant mothers who express an interest in participation will then be contacted to arrange a visit to the clinical trial site where informed consent will be undertaken. Written/thumb-printed informed consent will only be required from the expectant mother but in all cases it will be confirmed directly with the spouse (the father of the unborn baby) that they are aware of the study and have given their agreement. In the case of expectant mothers who are literate in English, they will be provided with a copy of the ICD but a member of the clinical trial team will nonetheless review the contents of the ICD line by line in English to ensure all details are covered and that the subject has the opportunity to ask questions regarding any aspect of the trial.
In the case of potential participants who are not literate in English but only in one of the local languages, a member of the clinical trial team fluent in the local language (as well as being English literate) will review the ICD line by line translating directly from the English ICD to the appropriate local language. In this case an impartial witness must be present throughout all elements of the consent process and must attest that the information on the ICD has been given accurately and in full. The impartial witness will also be required to sign the ICD to confirm that this has been the case.
Informed consent for study participation will be documented on the signature page of the ICD. The option to consent for the future use of any residual samples on study completion will also be given on the same page but the provision of such additional consent is not required for participation in the main trial.
A certified copy of the ICD is provided to the participant unless it is refused for some reason in which case it will be filed at the trial site. Such refusal must be documented in the subject's file so it is clear that the subject has been offered a copy The study will randomize 600 pregnant women at between 28 and 34 weeks gestation. Mothers will not be replaced following randomization. Screening of potentially eligible women will continue until this number is reached unless the trial is stopped for some other reason.
No further selection or assessment of eligibility will be undertaken on the newborn infants. All data will be included in the safety reporting irrespective of pregnancy outcome and safety follow-up should occur as planned for all infants. An infant may be excluded from the trial for the purposes of vaccination and/or clinical sampling if ongoing participation is considered to be against their best interests or if a contraindication to vaccination and/or to the obtaining of clinical samples is identified. An infant excluded in this way would not be replaced and hence this would not alter the target sample size of 600 pregnant women.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 600 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: 13-valent pneumococcal conjugate vaccine [Prevenar13®] plus tetanus toxoid
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
Biological: placebo 0.9% sodium chloride plus tetanus toxoid
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
Other: tetanus toxoid
Drug page: 13-valent pneumococcal vaccine
pregnant women will be given intramuscular PCV 13 vaccine between 28-34 weeks
Also known as: PCV13
pregnant women will be given intramuscular saline injection between 28-34 weeks
Also known as: placebo
new born babies will be given PCV13 vaccine at birth
safety in pregnant mothers (SAE)
SAE in expectant mothers from enrollment at 28 to 34 weeks gestation up to eight weeks from the end of the pregnancy
Time frame: from 28 weeks gestation to 8 weeks after delivery
safety in newborns (SAE)
SAE in infants from birth until nine months of age
Time frame: from birth until nine months of age
safety in vaccinated pregnant women (local and systemic reactogenicity)
Local and systemic reactogenicity within the first seven days of PCV13 administration to expectant mothers at between 28 and 34 weeks gestation
Time frame: within the first seven days from vaccination
safety in vaccinated newborns (local and systemic reactogenicity)
Local and systemic reactogenicity within the first seven days of PCV13 administration to newborn infants within the first week of life
Time frame: within the first seven days from vaccination
outcome of pregnancy
Pregnancy outcome
Time frame: from 28 weeks of gestation to delivery
cumulative carriage acquisition rate in infants
collection of Naso Pharyngeal Swab to assess Vaccine Type (VT) pneumococcal carriage rate
Time frame: from birth to 20 weeks of age
pneumococcal nasopharyngeal carriage rate of pregnant women
Nasopharyngeal carriage rate of total and VT pneumococcus in the mothers at delivery and at eight weeks following delivery
Time frame: at delivery and at 8 weeks after delivery
nasopharyngeal carriage rate of infants
Nasopharyngeal carriage rate of total and VT pneumococcus in infants up to nine months of age
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
quantitative antibodies measurements and sero protection rate for both 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
opsonophagocytic antibodies titres in infants
qualitative antibodies measurements in infants
Time frame: at birth, 8 & 20 weeks of age
polio virus type 1,2,3, Geometric Mean Titre (GMT) and hepatitis B GMC sero protection rate in infants
effect of co-administration of PCV13 with polio and hepatitis B vaccines
Time frame: at 8 weeks of age
diptheria toxoid GMC sero protection rate
the effect of the diptheria mutant carrier protein on subsequent vaccination to the infants
Time frame: at birth, 8 & 20 weeks of age
tetanus toxoid GMC sero protection rate in mothers
effect of co-administration with PCV13
Time frame: at birth
Ran from Mar 2016 to primary completion in Feb 2019, 35 months.
Of 41 non-industry phase 3 interventional studies under Pneumonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 57. This study's 35 months is above that.
Counting every sponsor, half of 67 studies reached it within 19 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: 13-valent pneumococcal vaccine
London School of Hygiene and Tropical Medicine →