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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04424316
Registration number
NCT04424316
Ethics application status
Date submitted
3/06/2020
Date registered
9/06/2020
Date last updated
4/03/2024
Titles & IDs
Public title
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
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Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
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Secondary ID [1]
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2019-002943-85
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Secondary ID [2]
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C3671008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSVpreF
Other interventions - Placebo
Experimental: RSVpreF vaccine - RSVpreF
Placebo Comparator: Placebo dose - Placebo
Other interventions: RSVpreF
RSV vaccine (RSVpreF)
Other interventions: Placebo
Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life
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Assessment method [1]
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The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
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Timepoint [1]
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Delivery to 180 days after delivery
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Primary outcome [2]
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The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of life
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Assessment method [2]
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The percentage relative risk reduction in the incidence of severe MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
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Timepoint [2]
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Delivery to 180 days after delivery
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Primary outcome [3]
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The percentage of infant participants with specific birth outcomes
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Assessment method [3]
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Describe specific birth outcomes for infant participants
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Timepoint [3]
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Birth
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Primary outcome [4]
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The percentage of infant participants with adverse events (AEs) from birth to 1 month of age
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Assessment method [4]
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Describe AE for infant participants from birth to 1 month of age
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Timepoint [4]
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Up to 1 month of age
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Primary outcome [5]
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The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of age
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Assessment method [5]
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Describe SAE and NDCMCs for infant participants from birth to 12 months of age
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Timepoint [5]
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From birth up to 12 months of age
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Primary outcome [6]
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The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of age
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Assessment method [6]
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Describe SAE and NDCMCs for infant participants from birth to 24 months of age
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Timepoint [6]
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From birth up to 24 months of age
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Primary outcome [7]
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Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7
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Assessment method [7]
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Describe local reactions and systemic events after vaccination
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Timepoint [7]
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From day of vaccination until 7 days after vaccination
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Primary outcome [8]
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Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination
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Assessment method [8]
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Describe adverse events (AE) after vaccination
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Timepoint [8]
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Within 1 month after vaccination
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Primary outcome [9]
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Percentage of maternal participants reporting SAEs
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Assessment method [9]
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Describe serious adverse events from enrolment up to 180 days after delivery
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Timepoint [9]
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From enrollment up to 180 days after delivery
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Secondary outcome [1]
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The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life
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Assessment method [1]
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The percentage relative risk reduction in the incidence of hospitalization due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
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Timepoint [1]
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Delivery to 360 days after delivery
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Secondary outcome [2]
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The percentage reduction in the incidence of all-cause MA-LRTI in infant participants
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Assessment method [2]
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The percentage relative risk reduction in the incidence of all-cause MA-LRTI in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
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Timepoint [2]
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Delivery to 360 days after delivery
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Secondary outcome [3]
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The percentage reduction in the incidence of MA-LRTI due to RSV in infants participants
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Assessment method [3]
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The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants
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Timepoint [3]
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Delivery to 360 days after delivery
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Eligibility
Key inclusion criteria
Inclusion Criteria - Maternal Participants:
- Healthy women =49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on
the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at
no known increased risk for complications.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.
- Receiving prenatal standard of care based on country requirements.
- Had a fetal anomaly ultrasound examination performed at =18 weeks of pregnancy with no
significant fetal abnormalities observed.
- Determined by medical history, physical examination, and clinical judgment to be
appropriate for inclusion in the study.
- Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV)
surface antigen test during this pregnancy and prior to randomization (Visit 1).
- Intention to deliver at a hospital or birthing facility where study procedures can be
obtained.
- Expected to be available for the duration of the study and can be contacted by
telephone during study participation.
- Participant is willing to give informed consent for her infant to participate in the
study.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent document (ICD) and in
this protocol OR If the maternal participant is illiterate, a thumbprinted informed
consent must be obtained, which must be signed and dated by an impartial witness who
was present throughout the entire informed consent process confirming that the
maternal participant has been informed of all pertinent aspects of the study.
Inclusion Criteria -Infant Participants:
- Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the
infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a
thumbprinted informed consent must have been obtained, which must have been signed and
dated by an impartial witness who was present throughout the entire informed consent
process confirming that the maternal participant/parent(s)/legal guardian(s) has been
informed of all pertinent aspects of the study for herself (maternal participant) and
her fetus/infant prior to taking part in the study.
- Parent(s)/legal guardian(s) willing and able to comply with scheduled visits,
treatment plan, laboratory tests, and other study procedures.
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Minimum age
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Years
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Maximum age
49
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria - Maternal Participants:
- Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available,
the BMI at the time of the first obstetric visit during the current pregnancy may be
used.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the investigational product or any
related vaccine.
- Current pregnancy resulting from in vitro fertilization.
- Current pregnancy complications or abnormalities at the time of consent that will
increase the risk associated with the participation in and completion of the study,
including but not limited to the following:
- Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
- Placental abnormality.
- Polyhydramnios or oligohydramnios.
- Significant bleeding or blood clotting disorder.
- Endocrine disorders, including untreated hyperthyroidism or untreated
hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes
mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if
uncontrolled at the time of consent.
- Any signs of premature labor with the current pregnancy or having ongoing
intervention (medical/surgical) in the current pregnancy to prevent preterm
birth.
- Prior pregnancy complications or abnormalities at the time of consent, based on the
investigator's judgment, that will increase the risk associated with the participation
in and completion of the study, including but not limited to the following:
- Prior preterm delivery =34 weeks' gestation.
- Prior stillbirth or neonatal death.
- Previous infant with a known genetic disorder or significant congenital anomaly.
- Major illness of the maternal participant or conditions of the fetus that, in the
investigator's judgment, will substantially increase the risk associated with the
maternal or infant participant's participation in, and completion of, the study or
could preclude the evaluation of the maternal participant's response (includes
positive serologic testing for regional endemic conditions assessed during routine
maternal care, as per local standards of care and obstetric recommendations).
- Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other
illness requiring chronic treatment with known immunosuppressant medications,
including monoclonal antibodies, within the year prior to enrollment.
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
- Participation in other studies involving investigational drug(s) within 28 days prior
to consent and/or during study participation.
- Receipt of monoclonal antibodies within the year prior to enrollment or the use of
systemic corticosteroids for >14 days within 28 days prior to study enrollment.
Permitted treatments include the receipt of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for
=14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or
eyes) corticosteroids.
- Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an
exclusion criterion for the study when elicited in participant screening, though it
may be considered illicit in some locales.
- Receipt of blood or plasma products or immunoglobulin (Ig), from 60 days before
investigational product administration, or planned receipt through delivery, with 1
exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
- Previous vaccination with any licensed or investigational RSV vaccine or planned.
Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or
emergency use will not be prohibited during the course of this study.
- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.
- Participants who are breastfeeding at the time of enrollment.
Exclusion Criteria -Infant Participants:
o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/10/2023
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Sample size
Target
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Accrual to date
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Final
14699
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Women's and Children's Hospital - North Adelaide
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Recruitment hospital [2]
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Monash Children's Hospital - Clayton
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Recruitment hospital [3]
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Barwon Health, University Hospital Geelong - Geelong
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Recruitment hospital [4]
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Perth Children's Hospital - Nedlands
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Recruitment hospital [5]
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Telethon Kids Institute - Nedlands
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Recruitment hospital [6]
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St John of God Hospital Subiaco - Subiaco
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Connecticut
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Nuevo LEON
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Mexico
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Durango
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Mexico
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Veracruz
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Netherlands
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Hoofddorp
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Netherlands
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Utrecht
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Country [89]
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New Zealand
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Auckland
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Country [90]
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New Zealand
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Canterbury
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Country [91]
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New Zealand
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State/province [91]
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Christchurch
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Country [92]
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New Zealand
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State/province [92]
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Wellington
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Country [93]
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Philippines
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State/province [93]
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Metro Manila
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Country [94]
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South Africa
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State/province [94]
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FREE State
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Country [95]
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South Africa
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State/province [95]
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Gauteng
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Country [96]
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South Africa
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State/province [96]
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Limpopo
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Country [97]
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South Africa
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State/province [97]
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Western CAPE
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Country [98]
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South Africa
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State/province [98]
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Cape Town
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Country [99]
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South Africa
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State/province [99]
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Soweto
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South Africa
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Worcester
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Country [101]
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Spain
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State/province [101]
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A Coruna
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Spain
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Malaga
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Spain
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Madrid
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Spain
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Mostoles
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Spain
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Valencia
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Taiwan
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State/province [106]
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Hsinchu City
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Taiwan
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State/province [107]
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Hsinchu
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Taiwan
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State/province [108]
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Kaohsiung
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Taiwan
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State/province [109]
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Taipei City
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Taiwan
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State/province [110]
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Taipei
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Country [111]
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Taiwan
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Taoyuan
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Funding & Sponsors
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Commercial sector/Industry
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Name
Pfizer
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Summary
Brief summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the
efficacy and safety of maternal immunization with RSVpreF against medically attended lower
respiratory tract illness (MA-LRTI) in infants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04424316
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04424316
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