Trial · NCT04605159
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
NCT04605159, Phase 3, Terminated, GlaxoSmithKline; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers. Trials, record NCT04605159. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04605159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
- NCT number
- NCT04605159
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 11,194 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- RSV MAT, Placebo
- First posted
- 2020-10-27
- Last updated
- 2025-02-20
- Other registries' IDs
- eudract:2020-001355-40
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was 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 met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Primary | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Secondary | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. |
| Secondary | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV MAT Group - Infant | RSV-associated LRTIs of any severity | 16 | Participants | |
| Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | Placebo Group - Infant | RSV-associated LRTIs of any severity | 24 | Participants | |
| Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV MAT Group - Infant | RSV-associated severe LRTIs | 8 | Participants | |
| Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | Placebo Group - Infant | RSV-associated severe LRTIs | 14 | Participants | |
| Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | RSV MAT Group - Infant | 640 | Participants | ||
| Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | Placebo Group - Infant | 323 | Participants | ||
| Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | RSV MAT Group - Infant | 19 | Participants | ||
| Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | Placebo Group - Infant | 4 | Participants | ||
| Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | RSV MAT Group - Infant | 2321 | Participants | ||
| Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | Placebo Group - Infant | 1135 | Participants |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RSV MAT Group - Mother | 3,557 | |
| Overall Study | STARTED | Placebo Group - Mother | 1,771 | |
| Overall Study | STARTED | RSV MAT Group - Infant | 3,494 | |
| Overall Study | STARTED | Placebo Group - Infant | 1,741 | |
| Overall Study | COMPLETED | RSV MAT Group - Mother | 3,374 | |
| Overall Study | COMPLETED | Placebo Group - Mother | 1,657 | |
| Overall Study | COMPLETED | RSV MAT Group - Infant | 3,236 | |
| Overall Study | COMPLETED | Placebo Group - Infant | 1,583 | |
| Overall Study | NOT COMPLETED | RSV MAT Group - Mother | 183 | |
| Overall Study | NOT COMPLETED | Placebo Group - Mother | 114 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6,220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | RSV MAT Group - Mother | 62 | 3,557 | 62 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Group - Mother | 24 | 1,771 | 24 |
| other | Anaemia | Blood and lymphatic system disorders | RSV MAT Group - Infant | 33 | 3,494 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Group - Infant | 12 | 1,741 | 12 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | RSV MAT Group - Mother | 0 | 3,557 | 0 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Placebo Group - Mother | 0 | 1,771 | 0 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | RSV MAT Group - Infant | 1 | 3,494 | 1 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Placebo Group - Infant | 2 | 1,741 | 2 |
| other | Anaemia of pregnancy | Blood and lymphatic system disorders | RSV MAT Group - Mother | 14 | 3,557 | 14 |
| other | Anaemia of pregnancy | Blood and lymphatic system disorders | Placebo Group - Mother | 5 | 1,771 | 5 |
1 to 10 of 6,220Source ClinicalTrials.gov
See all 6,220 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RSV MAT Group - Mother | 2 | 3,557 |
| Total, all-cause mortality | Placebo Group - Mother | 1 | 1,771 |
| Total, all-cause mortality | RSV MAT Group - Infant | 20 | 3,494 |
| Total, all-cause mortality | Placebo Group - Infant | 4 | 1,741 |
| Total, other adverse events | RSV MAT Group - Mother | 2,561 | 3,557 |
| Total, other adverse events | Placebo Group - Mother | 1,175 | 1,771 |
| Total, other adverse events | RSV MAT Group - Infant | 2,615 | 3,494 |
| Total, other adverse events | Placebo Group - Infant | 1,293 | 1,741 |
| Total, serious adverse events | RSV MAT Group - Mother | 827 | 3,557 |
| Total, serious adverse events | Placebo Group - Mother | 395 | 1,771 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons21
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | Trial comparisons |
| RSV MAT Group - Mother vs Placebo Group - Mother: Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | Trial comparisons |
| RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | Trial comparisons |
1 to 10 of 21
See all 21 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04605159
GET https://conductscience.org/api/trials/v1/NCT04605159/registered?page=2