Respiratory Syncytial Virus InfectionsPhase 3NCT04980391
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
A Phase 3 study testing RSV MAT in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 35 sites in 9 countries.
Trial summary
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV MAT
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 35 sitesin 9 countries
- Study dates
- 3 Aug 2021to 30 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Maternal participants
- Participants who can and will comply with the requirements of the protocol.
- Participants and LARs who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should either:
- include consent for both the maternal participant's participation* and participation of the infant after the infant's birth, or
- include consent for the maternal participant's participation* and expressed willingness to consider permitting the infant to take part after the infant's birth (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth).
- both mother and father should consent if local regulations / guidelines require it.
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- Pre-pregnancy Body Mass Index (based on participant's report) 18.5 to 39.9 kg/m^2, inclusive.
- Healthy adolescent pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention administration.
- OR
- Pregnant women, 18 to 49 YOA, inclusive, at the time of study intervention administration with:
- HIV infection AND/OR
- Obstetric complications or risk factors during the current pregnancy, where the expectant management of the pregnancy is possible and without evidence of non-reassuring fetal status (only cases for which fetal heart rate can be ascertained) as follows:
- Gestational diabetes, well-controlled on medications (with or without diet or exercise)
- Gestational hypertension, well-controlled on diet or medications below 160/110 mmHg.
- Pre-eclampsia without severe features (i.e. eclampsia, severe hypertension [>160/110 mmHg], organ dysfunction, unstable or complicated by [HELLP] syndrome).
- Fetal Growth Restriction in singleton pregnancies, with normal umbilical artery Doppler and estimated fetal weight 3 to 10th percentile for gestational age.
- History of threatened preterm labor in the current pregnancy, with no cervical dilation greater than 2 cm or effacement exceeding 50%, and/or no progressive change in cervical dilation or effacement detected by serial examinations, when maternal participant is asymptomatic
- Uncomplicated twin gestation.
- Pregnant females at 24^0/7 to 36^0/7 weeks of gestation at the time of study intervention administration (Day 1), as established by:
- Last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) (i.e. at or before 28 weeks of gestation).
- First or second trimester U/S only, if LMP is unknown/uncertain.
- Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
- The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) gestation age assessment tool
- Participants who are willing to provide cord blood.
- Willing to have their offspring followed-up after delivery for a period of 12 months.
- Participants who do not plan to give their offspring for adoption or place the child in care.
- Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be enrolled if they meet all inclusion criteria and none of the exclusion criteria.
- Infant participants
- Live-born from the study pregnancy.
- If required per local regulations / guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any infant study specific procedure. To comply with RTI surveillance and other protocol required procedures that begin immediately after birth: if written consent cannot be provided by the parent(s)/LAR(s) readily post-birth, verbal consent - if permitted per local regulation -- may be sought from the parent(s) / LAR(s) instead. Verbal consent should be documented in the source data by the investigator or delegate. The parent(s) / LAR(s) will provide additional, written informed consent by (or before) Visit 2-NB.
Who cannot join
- Maternal participants Medical conditions
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- Hypersensitivity to latex.
- Any pre-existing medical conditions or obstetric complications in the current pregnancy that, are poorly controlled and/or with clinical evidence of a non-reassuring fetal status and/or are likely to result in delivery within 7 days after study intervention administration and/or when the timing of planned delivery is within 7 days after study intervention administration and/or acute conditions requiring immediate medical attention for maternal stabilization and/or treatment.
- A multiple pregnancy with 3 or more fetuses.
- Complicated twin gestation.
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- Placenta Accreta Spectrum, including placenta increta, percreta, and accreta.
- Fetal structural defects or genetic abnormalities that affect (or are likely to affect) fetal health or survival during the first year of life.
- Known or suspected impairment of the immune system or immunodeficiency syndrome other than HIV.
- Lymphoproliferative disorder or malignancy within 5 years before study dose administration.
- Any illness of the mother or conditions of the fetus that, may substantially interfere with the maternal participant's ability to comply with study procedures, or could increase the risks to the mother or the fetus, or could preclude the evaluation of the participant's data.
- Any other clinical condition that, might pose additional risk to the participant due to participation in the study, as determined by medical history, physical examination or laboratory screening tests.
- Women with any diagnosis, condition, treatment, or other factor that, has the potential to affect or confound assessments of immunogenicity or safety
- Any conditions which, in the investigator's opinion, would increase the risks of study participation to the unborn infant.
- Prior/Concomitant therapy
- Prior receipt of an RSV maternal vaccine.
- Use of any investigational or non-registered product other than the study intervention(s) during the period beginning:
- For a drug, vaccine or medical device: 29 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
- For immunoglobulins: 90 days before the dose of study intervention(s), or their planned use during the study period.
- The exception to this is investigational products administered in the setting of a pandemic. Administration in this case should respect the same period outlined above prior to study intervention administration, but may be allowed following delivery.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 29 days before the study Day 1 and ending at delivery, with the exception of seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, all of which may be administered according to standard of care ≥ 15 days before or after study intervention (Day 1).
- Receipt of blood or plasma products or immunoglobulin, from 90 days before study intervention administration, or planned receipt through delivery, with the exception of Rho(D) immunoglobulin, which can be given at any time. In that sense, COVID-19 vaccines may be allowed, when administered ≥ 15 days before or after study vaccination.
- Administration of immune-modifying therapy within 6 months before study intervention administration, or planned administration through delivery, except if it is part of management of HIV infection.
- Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
- Other exclusions
- Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
- A local condition that precludes injection of the study vaccine/product or precludes assessment of local (administration site) reactogenicity.
- Consanguinity of maternal participant and her partner.
- Any study personnel or their immediate dependents, family, or household members.
- Infant participants
- Concurrently participating in another clinical trial, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Any condition which, would increase the risks of study participation to the infant.
- Child in care.
Trial locations and contacts
35 sites in 9 countries.
35 sites in 9 countries
United States16 sites
GSK Investigational Site
Arlington, Texas, 76012
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Dothan, Alabama, 36305
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Grapevine, Texas, 76051
GSK Investigational Site
Houston, Texas, 77008
GSK Investigational Site
Lafayette, Louisiana, 70508
GSK Investigational Site
League City, Texas, 77573
GSK Investigational Site
Missoula, Montana, 59804
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Phoenix, Arizona, 85015
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
Weatherford, Texas, 76086
Spain6 sites
GSK Investigational Site
Boadilla Del Monte Madrid, 28660
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Málaga, 29004
GSK Investigational Site
TorrejOn Ardoz Madrid, 28850
Brazil3 sites
GSK Investigational Site
Caxias do Sul, 95070-560
GSK Investigational Site
RibeirAo PretoSP, 14048-900
GSK Investigational Site
Santa Maria, 97105-900
Italy3 sites
GSK Investigational Site
Messina, 98124
GSK Investigational Site
Perugia, 06129
GSK Investigational Site
Prato, 59100
Canada2 sites
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Montreal, Quebec, H3T 1C5
India2 sites
GSK Investigational Site
Bhubaneswar, 751019
GSK Investigational Site
Mysuru, 570015
About this study
Official title: A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers.
Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSV MAT, Placebo
- Keywords
- Respiratory Syncytial Virus Maternal vaccine, Safety, Reactogenicity, Immune response, High risk pregnant women, Teenage girls
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV MATBiological
Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
PlaceboDrug
Single dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| RSV_MAT Group | Experimental | Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. Receives: Biological: RSV MAT |
| Control Group | Placebo comparator | Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. Receives: Drug: Placebo |
| RSV_MAT Group-Infant | No intervention | This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. |
| Control Group-Infant | No intervention | This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Maternal Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters.
Measured: From Day 1 to Day 7 included
Percentage of Maternal Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Measured: From Day 1 to Day 7 included
Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: From Day 1 to Day 30 included
Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery
An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly
The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery
Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria:
- Change in medication and/or medication dose.
- Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication.
- SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Measured: From Day 1 up to 42 days post-delivery, an average of 2 months
Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth
Neonatal/infant AESIs included low birth weight (below [<] 2500 grams), very low birth weight (<1500 grams), extremely low birth weight (<1000 grams), preterm birth (<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above [>=] 28 and <37 weeks).
Measured: From birth up to 42 days post-birth, an average of 2 months
Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Measured: From birth up to 42 days post-birth, an average of 2 months
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Measured: From birth up to 42 days post-birth, an average of 2 months
Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Measured: From birth up to 42 days post-birth, an average of 2 months
Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Measured: From birth up to 180 days post-birth
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Measured: From birth up to 180 days post-birth
Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Measured: From birth up to 180 days post-birth
Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Measured: From birth up to 365 days post-birth
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Measured: From birth up to 365 days post-birth
Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Measured: From birth up to 365 days post-birth
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1)
RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL).
Measured: At pre-dosing (Day 1)
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Measured: At delivery
RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1)
RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs).
Measured: At pre-dosing (Day 1)
RSV-A Neutralizing Titers for Maternal Participants at Delivery
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At delivery
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth [if no cord blood could be obtained]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery).
Measured: At delivery (for maternal participants) or within 72 hours after birth (for infant participants)
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Measured: At delivery or within 72 hours after birth
RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Measured: At delivery or within 72 hours after birth
Secondary outcomes (20)
Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Measured: From Day 1 up to 180 days post-delivery
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Measured: From Day 1 up to 180 days post-delivery
Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Measured: From Day 1 up to 180 days post-delivery
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgement and the following criteria:
- Change in medication and/or medication dose.
- Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication.
- SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Measured: From Day 1 up to 180 days post-delivery
Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery
RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection.
Measured: From Day 1 up to 180 days post-delivery
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth
An RSV-associated LRTI is characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI meets the case definition of RSV-LRTI AND is additionally characterized by a SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious.
Measured: From birth up to 365 days post-birth
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth
RSV-associated hospitalization was defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization was defined as admission for observation or treatment based on the judgment of a health care provider.
Measured: From birth up to 365 days post-birth
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Measured: At Day 31 post-dosing
RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 31 post-dosing
RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At pre-dosing (Day 1), Day 31 post-dosing and delivery
RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Measured: At delivery or within 72 hours after birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Measured: At Day 43 post-birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Measured: At Day 121 post-birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Measured: At Day 181 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 43 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 121 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 181 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 43 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 121 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Measured: At Day 181 post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start3 Aug 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Why it stopped: Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980391
- Sponsor's protocol ID
- 214725
- Other IDs
- 2021-000994-96
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2021
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Bebia Z, Dieussaert I, Jose L, Kantele A, Valimaa H, Middleton G, Pirela HDE, Reyes O, Sanchez MG, Vigil-De Gracia P, Hua N, Kirabo M, Lese P, Kim JH. Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants. Hum Vaccin Immunother. 2026 Dec;22(1):2613565. doi: 10.1080/21645515.2026.2613565. Epub 2026 Mar 1.
PubMed 41766205
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of a Single Intramuscular Dose of Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
- ClinicalTrials.gov ID
- NCT04980391
- Acronym / sponsor ID
- 214725
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus Maternal vaccine, Safety, Reactogenicity, Immune response, High risk pregnant women, Teenage girls
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.
- Enrolment
- 384 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers.
Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RSV_MAT Group | Experimental | Biological: RSV MATMaternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. |
| Control Group | Placebo comparator | Drug: PlaceboMaternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. |
| RSV_MAT Group-Infant | No intervention | –This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. |
| Control Group-Infant | No intervention | –This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (30 listed)
- Maternal participants
- Participants who can and will comply with the requirements of the protocol.
- Participants and LARs who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should either:
- Pre-pregnancy Body Mass Index (based on participant's report) 18.5 to 39.9 kg/m^2, inclusive.
- Healthy adolescent pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention administration.
Key exclusion criteria (34 listed)
- Maternal participants Medical conditions
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- Hypersensitivity to latex.
- Any pre-existing medical conditions or obstetric complications in the current pregnancy that, are poorly controlled and/or with clinical evidence of a non-reassuring fetal status and/or are likely to result in delivery within 7 days after study intervention administration and/or when the timing of planned delivery is within 7 days after study intervention administration and/or acute conditions requiring immediate medical attention for maternal stabilization and/or treatment.
- A multiple pregnancy with 3 or more fetuses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV MATSingle dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1. | Biological | RSV_MAT Group |
| PlaceboSingle dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1. | Drug | Control Group |
Primary outcome
Percentage of Maternal Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 1 to Day 7 included
Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters.
Percentage of Maternal Participants Reporting Any Solicited Systemic Events
Time frame: From Day 1 to Day 7 included
Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: From Day 1 to Day 30 included
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported.
Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction.
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria: * Change in medication and/or medication dose. * Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth
Time frame: From birth up to 42 days post-birth, an average of 2 months
Neonatal/infant AESIs included low birth weight (below [<] 2500 grams), very low birth weight (<1500 grams), extremely low birth weight (<1000 grams), preterm birth (<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above [>=] 28 and <37 weeks).
Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth
Time frame: From birth up to 42 days post-birth, an average of 2 months
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth
Time frame: From birth up to 42 days post-birth, an average of 2 months
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth
Time frame: From birth up to 42 days post-birth, an average of 2 months
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth
Time frame: From birth up to 180 days post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth
Time frame: From birth up to 180 days post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth
Time frame: From birth up to 180 days post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth
Time frame: From birth up to 365 days post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth
Time frame: From birth up to 365 days post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth
Time frame: From birth up to 365 days post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1)
Time frame: At pre-dosing (Day 1)
RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL).
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery
Time frame: At delivery
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1)
Time frame: At pre-dosing (Day 1)
RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs).
RSV-A Neutralizing Titers for Maternal Participants at Delivery
Time frame: At delivery
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
Time frame: At delivery (for maternal participants) or within 72 hours after birth (for infant participants)
The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth [if no cord blood could be obtained]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery).
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth
Time frame: At delivery or within 72 hours after birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
Time frame: At delivery or within 72 hours after birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
20 secondary outcomes
Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery
Time frame: From Day 1 up to 180 days post-delivery
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery
Time frame: From Day 1 up to 180 days post-delivery
Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery
Time frame: From Day 1 up to 180 days post-delivery
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery
Time frame: From Day 1 up to 180 days post-delivery
Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery
Time frame: From Day 1 up to 180 days post-delivery
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth
Time frame: From birth up to 365 days post-birth
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth
Time frame: From birth up to 365 days post-birth
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing
Time frame: At Day 31 post-dosing
RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing
Time frame: At Day 31 post-dosing
RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery
Time frame: At pre-dosing (Day 1), Day 31 post-dosing and delivery
RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
Time frame: At delivery or within 72 hours after birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth
Time frame: At Day 43 post-birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth
Time frame: At Day 121 post-birth
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth
Time frame: At Day 181 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth
Time frame: At Day 43 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth
Time frame: At Day 121 post-birth
RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth
Time frame: At Day 181 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth
Time frame: At Day 43 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth
Time frame: At Day 121 post-birth
RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth
Time frame: At Day 181 post-birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41766205Bebia Z, Dieussaert I, Jose L, Kantele A, Valimaa H, Middleton G, Pirela HDE, Reyes O, Sanchez MG, Vigil-De Gracia P, Hua N, Kirabo M, Lese P, Kim JH. Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants. Hum Vaccin Immunother. 2026 Dec;22(1):2613565. doi: 10.1080/21645515.2026.2613565. Epub 2026 Mar 1.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSV MAT in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 35 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Spain, Brazil, Italy, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Maternal Participants Reporting Any Solicited Administration Site Events (time frame: From Day 1 to Day 7 included). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.