Download PDF

Clinical Trial Results:
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

Summary
EudraCT number	2021-000994-96
Trial protocol	FI ES IT Outside EU/EEA
Global end of trial date	30 May 2023

Results information
Results version number	v2(current)
This version publication date	06 Mar 2024
First version publication date	14 Dec 2023
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

214725

ISRCTN number

US NCT number

NCT04980391

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-002821-PIP01-20

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Oct 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 May 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

• To evaluate the safety and reactogenicity of a single IM dose of study intervention administered to maternal participants up to 42 days post-delivery. • To evaluate the pregnancy outcomes and pregnancy-related AESIs up to 42 days post-delivery, in maternal participants who received a single IM dose of study intervention. • To evaluate safety up to 42 days post-birth in infants born to maternal participants who received a single IM dose of study intervention. • To evaluate the safety of the vaccine in infants up to 365 days post-birth. • To evaluate the immunogenicity of a single IM dose of study intervention administered to maternal participants, at delivery. • To evaluate the transfer of RSV-specific antibodies from maternal participants who received a single IM dose of study intervention to their infants at delivery. • To evaluate the RSV-specific antibody levels at birth in infants born to maternal participants who received a single IM dose of study intervention.

Protection of trial subjects

Maternal participants remained under observation for 30 minutes after the administration of the study intervention to ensure that immediate treatment would be provided in the event of a hypersensitivity reaction, or syncope.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Aug 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 21

Country: Number of subjects enrolled

Canada: 15

Country: Number of subjects enrolled

Finland: 15

Country: Number of subjects enrolled

India: 7

Country: Number of subjects enrolled

Italy: 5

Country: Number of subjects enrolled

Panama: 63

Country: Number of subjects enrolled

South Africa: 94

Country: Number of subjects enrolled

Spain: 81

Country: Number of subjects enrolled

United States: 83

Worldwide total number of subjects

384

EEA total number of subjects

101

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

161

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

166

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

The study was originally double-blinded, but due to a safety signal, it was fully unblinded to ensure the safety monitoring of the participants.

Are arms mutually exclusive

Yes

RSV_MAT Group-Mother

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

RSV MAT

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.

Control Group-Mother

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose of Placebo, administered intramuscularly in the non-dominant arm, at Day 1.

RSV_MAT Group-Infant

Arm description

This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Control Group-Infant

Arm description

This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1 ^[1]	RSV_MAT Group-Mother	Control Group-Mother	RSV_MAT Group-Infant	Control Group-Infant
Started	113	56	132	66
Completed	107	52	124	61
Not completed	6	4	8	5
Death	-	-	1	1
WITHDRAWAL BY SUBJECT'S PARENT(S)/LAR(S)	-	-	3	-
MIGRATED / MOVED FROM THE STUDY AREA	1	1	2	1
Lost to follow-up	3	3	2	3
WITHDRAWAL BY SUBJECT, NOT DUE TO AN ADVERSE EVENT	2	-	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed.

Baseline characteristics

Top of page

Reporting group title

RSV_MAT Group-Mother

Reporting group description

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.

Reporting group title

Control Group-Mother

Reporting group description

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.

Reporting group title

RSV_MAT Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Control Group-Infant

Reporting group description

This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

Reporting group values	RSV_MAT Group-Mother	Control Group-Mother	RSV_MAT Group-Infant	Control Group-Infant	Total
Number of subjects	113	56	132	66	367
Age Categorical
Units: Participants
0 to 1 years of age	0	0	132	66	198
15 < 18 years of age	13	6	0	0	19
18 to 49 years of age	100	50	0	0	150
Sex: Female, Male
Units: Participants
Female	113	56	63	29	261
Male	0	0	69	37	106
Race/Ethnicity, Customized
Units: Subjects
Asian	4	1	4	1	10
Black or African American	33	18	33	18	102
White	52	24	67	34	177
Other, unspecified	24	13	28	13	78

End points

Top of page

Reporting group title

RSV_MAT Group-Mother

Reporting group description

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.

Reporting group title

Control Group-Mother

Reporting group description

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.

Reporting group title

RSV_MAT Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Control Group-Infant

Reporting group description

This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

Subject analysis set title

RSV_MAT Group

Subject analysis set type

Per protocol

Subject analysis set description

This group consisted of pairs of maternal participants from RSV_MAT Group - Mother and infant participants from RSV_MAT Group - Infant.

Subject analysis set title

Control Group

Subject analysis set type

Per protocol

Subject analysis set description

This group consisted of pairs of maternal participants from Control Group - Mother and infant participants from Control Group - Infant.

Primary: Percentage of maternal participants reporting any solicited administration site events

Top of page

End point title

Percentage of maternal participants reporting any solicited administration site events ^[1] ^[2]

End point description

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. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.

End point type

Primary

End point timeframe

From Day 1 to Day 7 included

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	54
Units: Percentage of participants
number (confidence interval 95%)
Any Erythema	0.9 (0.0 to 4.8)	0 (0 to 6.6)
Any Pain	44.2 (34.9 to 53.9)	14.8 (6.6 to 27.1)
Any Swelling	0 (0 to 3.2)	1.9 (0.0 to 9.9)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting any solicited systemic events

Top of page

End point title

Percentage of maternal participants reporting any solicited systemic events ^[3] ^[4]

End point description

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. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.

End point type

Primary

End point timeframe

From Day 1 to Day 7 included

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	54
Units: Percentage of participants
number (confidence interval 95%)
Any Abdominal pain	20.4 (13.4 to 29.0)	16.7 (7.9 to 29.3)
Any Diarrhea	20.4 (13.4 to 29.0)	7.4 (2.1 to 17.9)
Any Fatigue	28.3 (20.2 to 37.6)	27.8 (16.5 to 41.6)
Any Headache	39.8 (30.7 to 49.5)	38.9 (25.9 to 53.1)
Any Nausea	24.8 (17.1 to 33.8)	20.4 (10.6 to 33.5)
Any Fever	0 (0 to 3.2)	0 (0 to 6.6)
Any Vomiting	8.0 (3.7 to 14.6)	20.4 (10.6 to 33.5)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery ^[5] ^[6]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)	29.2 (21.0 to 38.5)	19.6 (10.2 to 32.4)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting any unsolicited adverse events (AEs)

Top of page

End point title

Percentage of maternal participants reporting any unsolicited adverse events (AEs) ^[7] ^[8]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 to Day 30 included

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)	34.5 (25.8 to 44.0)	37.5 (24.9 to 51.5)

No statistical analyses for this end point

Primary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery

Top of page

End point title

Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery ^[9] ^[10]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Participants	0	0

No statistical analyses for this end point

Primary: 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

Top of page

End point title

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 ^[11] ^[12]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/legally acceptable representatives (LARs) completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of live births
number (confidence interval 95%)
LIVE BIRTH WITH NO CONGENITAL ANOMALIES	86.4 (79.3 to 91.7)	84.8 (73.9 to 92.5)
LIVE BIRTH WITH ONLY MINOR CONGENITAL ANOMALY(IES)	10.6 (5.9 to 17.2)	13.6 (6.4 to 24.3)
LIVE BIRTH WITH >= MAJOR CONGENITAL ANOMALY	3.0 (0.8 to 7.6)	1.5 (0.0 to 8.2)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery ^[13] ^[14]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)	57.5 (47.9 to 66.8)	58.9 (45.0 to 71.9)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery ^[15] ^[16]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)
Preterm labor	8.0 (3.7 to 14.6)	7.1 (2.0 to 17.3)
Provider-initiated preterm birth	3.5 (1.0 to 8.8)	5.4 (1.1 to 14.9)
Premature preterm rupture of membranes	1.8 (0.2 to 6.2)	5.4 (1.1 to 14.9)
Pre-eclampsia	4.4 (1.5 to 10.0)	3.6 (0.4 to 12.3)
Pre-eclampsia with severe features	4.4 (1.5 to 10.0)	0 (0 to 6.4)
Gestational hypertension	0.9 (0.0 to 4.8)	3.6 (0.4 to 12.3)
Fetal growth restriction	1.8 (0.2 to 6.2)	3.6 (0.4 to 12.3)

No statistical analyses for this end point

Primary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery ^[17] ^[18]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Primary

End point timeframe

From Day 1 up to 42 days post-delivery, an average of 2 months

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)
Change In Medication And/Or Medication Dose	1.8 (0.2 to 6.2)	1.8 (0.0 to 9.6)
Medically Attended Event	1.8 (0.2 to 6.2)	7.1 (2.0 to 17.3)
SAE And/Or Hospitalization	1.8 (0.2 to 6.2)	3.6 (0.4 to 12.3)

No statistical analyses for this end point

Primary: Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth

Top of page

End point title

Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth ^[19] ^[20]

End point description

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). Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 42 days post-birth, an average of 2 months

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)
Low Birth Weight (<2500 grams)	16.7 (10.7 to 24.1)	18.2 (9.8 to 29.6)
Very Low Birth Weight (<1500 grams)	2.3 (0.5 to 6.5)	1.5 (0.0 to 8.2)
Extremely Low Birth Weight (<1000 grams)	0 (0 to 2.8)	1.5 (0.0 to 8.2)
Preterm Birth (<37 Weeks Of Gestational Age)	18.2 (12.0 to 25.8)	19.7 (10.9 to 31.3)
Small For Gestational Age	14.4 (8.9 to 21.6)	27.3 (17.0 to 39.6)
Congenital Anomalies	3.0 (0.8 to 7.6)	0 (0 to 5.4)
Neonatal Death In A Preterm Live Birth	0.8 (0.0 to 4.1)	1.5 (0.0 to 8.2)

No statistical analyses for this end point

Primary: Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth

Top of page

End point title

Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth ^[21] ^[22]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 42 days post-birth, an average of 2 months

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	20.5 (13.9 to 28.3)	27.3 (17.0 to 39.6)

No statistical analyses for this end point

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth

Top of page

End point title

Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth ^[23] ^[24]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 42 days post-birth, an average of 2 months

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Participants	0	0

No statistical analyses for this end point

Primary: Percentage of infant participants reporting MAEs from birth up to 42 days post-birth

Top of page

End point title

Percentage of infant participants reporting MAEs from birth up to 42 days post-birth ^[25] ^[26]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 42 days post-birth, an average of 2 months

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	56.8 (47.9 to 65.4)	54.5 (41.8 to 66.9)

No statistical analyses for this end point

Primary: Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth

Top of page

End point title

Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth ^[27] ^[28]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 180 days post-birth

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	25.0 (17.9 to 33.3)	30.3 (19.6 to 42.9)

No statistical analyses for this end point

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth

Top of page

End point title

Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth ^[29] ^[30]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 180 days post-birth

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Participants	0	0

No statistical analyses for this end point

Primary: Percentage of infant participants reporting MAEs from birth up to 180 days post-birth

Top of page

End point title

Percentage of infant participants reporting MAEs from birth up to 180 days post-birth ^[31] ^[32]

End point description

End point type

Primary

End point timeframe

From birth up to 180 days post-birth

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	77.3 (69.2 to 84.1)	69.7 (57.1 to 80.4)

No statistical analyses for this end point

Primary: Percentage of infant participants reporting MAEs from birth up to 365 days post-birth

Top of page

End point title

Percentage of infant participants reporting MAEs from birth up to 365 days post-birth ^[33] ^[34]

End point description

End point type

Primary

End point timeframe

From birth up to 365 days post-birth

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	86.4 (79.3 to 91.7)	75.8 (63.6 to 85.5)

No statistical analyses for this end point

Primary: Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth

Top of page

End point title

Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth ^[35] ^[36]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 365 days post-birth

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	26.5 (19.2 to 34.9)	31.8 (20.9 to 44.4)

No statistical analyses for this end point

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth

Top of page

End point title

Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth ^[37] ^[38]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Primary

End point timeframe

From birth up to 365 days post-birth

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Participants	0	0

No statistical analyses for this end point

Primary: RSV MAT IgG-specific antibody concentrations for maternal participants at delivery

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for maternal participants at delivery ^[39] ^[40]

End point description

RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At delivery

Notes
[39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	99	44
Units: ELU/mL
geometric mean (confidence interval 95%)	70337.1 (60711.34 to 81489.07)	4421 (3477.90 to 5619.80)

No statistical analyses for this end point

Primary: RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1)

Top of page

End point title

RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1) ^[41] ^[42]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At pre-dosing (Day 1)

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	103	48
Units: Titers
geometric mean (confidence interval 95%)	681.5 (578.33 to 803.11)	752.4 (580.25 to 975.50)

No statistical analyses for this end point

Primary: RSV-A neutralizing titers for maternal participants at delivery

Top of page

End point title

RSV-A neutralizing titers for maternal participants at delivery ^[43] ^[44]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At delivery

Notes
[43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	99	44
Units: Titers
geometric mean (confidence interval 95%)	6240.3 (5026.02 to 7747.88)	612.8 (455.82 to 823.83)

No statistical analyses for this end point

Primary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1)

Top of page

End point title

RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1) ^[45] ^[46]

End point description

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). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At pre-dosing (Day 1)

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	103	48
Units: ELU/mL
geometric mean (confidence interval 95%)	4981.6 (4405.14 to 5633.53)	5981.7 (4908.71 to 7289.11)

No statistical analyses for this end point

Primary: RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth

Top of page

End point title

RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth ^[47] ^[48]

End point description

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). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) have protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At delivery or within 72 hours after birth

Notes
[47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	91	37
Units: Titers
geometric mean (confidence interval 95%)	9080.2 (7449.56 to 11067.75)	694.6 (495.72 to 973.37)

No statistical analyses for this end point

Primary: Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations

Top of page

End point title

Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations ^[49]

End point description

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). Analysis was performed on all pairs of maternal participants (from Per Protocol Set Immunogenicity - Maternal) and their infants (from Per Protocol Set Immunogenicity - Infant) with available results for this outcome measure at the specified time points.

End point type

Primary

End point timeframe

At delivery (for maternal participants) or within 72 hours after birth (for infant participants)

Notes
[49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	RSV_MAT Group	Control Group
Number of subjects analysed	86	37
Units: Ratio
geometric mean (confidence interval 95%)	1.33 (1.04 to 1.70)	2.30 (1.63 to 3.25)

No statistical analyses for this end point

Primary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth ^[50] ^[51]

End point description

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). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.

End point type

Primary

End point timeframe

At delivery or within 72 hours after birth

Notes
[50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	88	37
Units: ELU/mL
geometric mean (confidence interval 95%)	77625.1 (63706.97 to 94583.89)	9228 (6540.47 to 13019.71)

No statistical analyses for this end point

Secondary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery

Top of page

End point title

Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery ^[52]

End point description

End point type

Secondary

End point timeframe

From Day 1 up to 180 days post-delivery

Notes
[52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Participants	0	0

No statistical analyses for this end point

Secondary: Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery ^[53]

End point description

End point type

Secondary

End point timeframe

From Day 1 up to 180 days post-delivery

Notes
[53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)	29.2 (21.0 to 38.5)	19.6 (10.2 to 32.4)

No statistical analyses for this end point

Secondary: Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery ^[54]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Secondary

End point timeframe

From Day 1 up to 180 days post-delivery

Notes
[54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)	61.1 (51.4 to 70.1)	60.7 (46.8 to 73.5)

No statistical analyses for this end point

Secondary: Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery

Top of page

End point title

Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery ^[55]

End point description

RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Secondary

End point timeframe

From Day 1 up to 180 days post-delivery

Notes
[55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Participants	0	0

No statistical analyses for this end point

Secondary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery

Top of page

End point title

Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery ^[56]

End point description

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. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.

End point type

Secondary

End point timeframe

From Day 1 up to 180 days post-delivery

Notes
[56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	113	56
Units: Percentage of participants
number (confidence interval 95%)
Change In Medication And/Or Medication Dose	1.8 (0.2 to 6.2)	1.8 (0.0 to 9.6)
Medically Attended Event	1.8 (0.2 to 6.2)	7.1 (2.0 to 17.3)
SAE And/Or Hospitalization	1.8 (0.2 to 6.2)	3.6 (0.4 to 12.3)

No statistical analyses for this end point

Secondary: Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth

Top of page

End point title

Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth ^[57]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent.

End point type

Secondary

End point timeframe

From birth up to 365 days post-birth

Notes
[57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)	3.0 (0.8 to 7.6)	10.6 (4.4 to 20.6)

No statistical analyses for this end point

Secondary: 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

Top of page

End point title

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 ^[58]

End point description

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. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.

End point type

Secondary

End point timeframe

From birth up to 365 days post-birth

Notes
[58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	132	66
Units: Percentage of participants
number (confidence interval 95%)
Any RSV-associated LRTIs	0.8 (0.0 to 4.1)	3.0 (0.4 to 10.5)
RSV-associated Severe LRTIs	0 (0 to 2.8)	0 (0 to 5.4)

No statistical analyses for this end point

Secondary: RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing ^[59]

End point description

RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.

End point type

Secondary

End point timeframe

At Day 31 post-dosing

Notes
[59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	89	38
Units: ELU/mL
geometric mean (confidence interval 95%)	113957.1 (102340.44 to 126892.37)	5510.6 (4370.30 to 6948.51)

No statistical analyses for this end point

Secondary: RSV-A neutralizing titers for maternal participants at Day 31 post-dosing

Top of page

End point title

RSV-A neutralizing titers for maternal participants at Day 31 post-dosing ^[60]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.

End point type

Secondary

End point timeframe

At Day 31 post-dosing

Notes
[60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	89	38
Units: Titers
geometric mean (confidence interval 95%)	9959.7 (8239.95 to 12038.40)	575.2 (418.40 to 790.84)

No statistical analyses for this end point

Secondary: RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery

Top of page

End point title

RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery ^[61]

End point description

RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time points, minus those participants with protocol deviations that lead to exclusion.

End point type

Secondary

End point timeframe

At pre-dosing (Day 1), Day 31 post-dosing and delivery

Notes
[61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the maternal participants.

End point values	RSV_MAT Group-Mother	Control Group-Mother
Number of subjects analysed	103	47
Units: Titers
geometric mean (confidence interval 95%)
Day 1 (N=103;47)	756.6 (646.03 to 885.98)	863.4 (664.87 to 1121.12)
Day 31 (N=89;38)	9928.9 (8331.29 to 11832.87)	640.7 (475.93 to 862.38)
Delivery (N=99;43)	6336.9 (5261.95 to 7631.49)	650.2 (492.25 to 858.82)

No statistical analyses for this end point

Secondary: RSV-A neutralizing titers for infant participants at Day 43 post-birth

Top of page

End point title

RSV-A neutralizing titers for infant participants at Day 43 post-birth ^[62]

End point description

End point type

Secondary

End point timeframe

At Day 43 post-birth

Notes
[62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	17	5
Units: Titers
geometric mean (confidence interval 95%)	3203.8 (1919.77 to 5346.65)	240.5 (53.94 to 1072.76)

No statistical analyses for this end point

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 181 post-birth

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for infant participants at Day 181 post-birth ^[63]

End point description

RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "241".

End point type

Secondary

End point timeframe

At Day 181 post-birth

Notes
[63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	1
Units: ELU/mL
geometric mean (confidence interval 95%)	2857.8 (1836.27 to 4447.53)	241 (0 to 241)

No statistical analyses for this end point

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 43 post-birth

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for infant participants at Day 43 post-birth ^[64]

End point description

End point type

Secondary

End point timeframe

At Day 43 post-birth

Notes
[64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	16	5
Units: ELU/mL
geometric mean (confidence interval 95%)	29932.5 (22576.08 to 39686.04)	1310 (546.48 to 3140.43)

No statistical analyses for this end point

Secondary: RSV-B neutralizing titers for infant participants at delivery or within 72 hours after birth

Top of page

End point title

RSV-B neutralizing titers for infant participants at delivery or within 72 hours after birth ^[65]

End point description

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). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.

End point type

Secondary

End point timeframe

At delivery or within 72 hours after birth

Notes
[65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	91	37
Units: Titers
geometric mean (confidence interval 95%)	9145.5 (7458.74 to 11213.76)	779.7 (566.83 to 1072.49)

No statistical analyses for this end point

Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 121 post-birth

Top of page

End point title

RSV MAT IgG-specific antibody concentrations for infant participants at Day 121 post-birth ^[66]

End point description

End point type

Secondary

End point timeframe

At Day 121 post-birth

Notes
[66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	3
Units: ELU/mL
geometric mean (confidence interval 95%)	4365.1 (12.84 to 1484365.32)	446.8 (151.14 to 1320.88)

No statistical analyses for this end point

Secondary: RSV-B neutralizing titers for infant participants at Day 43 post-birth

Top of page

End point title

RSV-B neutralizing titers for infant participants at Day 43 post-birth ^[67]

End point description

End point type

Secondary

End point timeframe

At Day 43 post-birth

Notes
[67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	17	5
Units: Titers
geometric mean (confidence interval 95%)	3012.8 (1789.81 to 5071.60)	273.3 (106.14 to 703.45)

No statistical analyses for this end point

Secondary: RSV-A neutralizing titers for infant participants at Day 121 post-birth

Top of page

End point title

RSV-A neutralizing titers for infant participants at Day 121 post-birth ^[68]

End point description

End point type

Secondary

End point timeframe

At Day 121 post-birth

Notes
[68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	3
Units: Titers
geometric mean (confidence interval 95%)	607.9 (0.28 to 1322707.87)	94.1 (68.10 to 130.08)

No statistical analyses for this end point

Secondary: RSV-A neutralizing titers for infant participants at Day 181 post-birth

Top of page

End point title

RSV-A neutralizing titers for infant participants at Day 181 post-birth ^[69]

End point description

RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "115".

End point type

Secondary

End point timeframe

At Day 181 post-birth

Notes
[69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	1
Units: Titers
geometric mean (confidence interval 95%)	755 (0.45 to 1262151.64)	115 (0 to 115)

No statistical analyses for this end point

Secondary: RSV-B neutralizing titers for infant participants at Day 121 post-birth

Top of page

End point title

RSV-B neutralizing titers for infant participants at Day 121 post-birth ^[70]

End point description

End point type

Secondary

End point timeframe

At Day 121 post-birth

Notes
[70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	3
Units: Titers
geometric mean (confidence interval 95%)	622.7 (2.98 to 129923.70)	54.9 (27.69 to 108.83)

No statistical analyses for this end point

Secondary: RSV-B neutralizing titers for infant participants at Day 181 post-birth

Top of page

End point title

RSV-B neutralizing titers for infant participants at Day 181 post-birth ^[71]

End point description

RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "63".

End point type

Secondary

End point timeframe

At Day 181 post-birth

Notes
[71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the infants born to maternal participants.

End point values	RSV_MAT Group-Infant	Control Group-Infant
Number of subjects analysed	2	1
Units: Titers
geometric mean (confidence interval 95%)	327.9 (6.57 to 16367.16)	63 (0 to 63)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Maternal groups: Solicited AEs -from Day 1 to Day 7 (included), Unsolicited AEs -from Day 1 to Day 30 (included) after vaccination. SAEs -from Day 1 up to 180 days post-delivery. Infant groups: SAEs & non-serious AEs -from birth up to 365 days post-birth.

Adverse event reporting additional description

"Death neonatal" is considered a serious adverse event for the Control Group-Mother, since the death did not occur from a study pregnancy, but from a subsequent pregnancy. Therefore, due to the fact that the neonate was not considered a study participant, the "death neonatal" event was captured under maternal SAEs.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

RSV_MAT Group-Mother

Reporting group description

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.

Reporting group title

Control Group-Infant

Reporting group description

This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

Reporting group title

RSV_MAT Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

Reporting group title

Control Group-Mother

Reporting group description

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.

Serious adverse events	RSV_MAT Group-Mother	Control Group-Infant	RSV_MAT Group-Infant	Control Group-Mother
Total subjects affected by serious adverse events
subjects affected / exposed	33 / 113 (29.20%)	21 / 66 (31.82%)	35 / 132 (26.52%)	11 / 56 (19.64%)
number of deaths (all causes)	0	1	1	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Medically induced preterm birth
subjects affected / exposed	3 / 113 (2.65%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Foetal dystocia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal distress syndrome
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failed induction of labour
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cephalo-pelvic disproportion
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Breech delivery
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Low birth weight baby
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	8 / 132 (6.06%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice neonatal
subjects affected / exposed	0 / 113 (0.00%)	7 / 66 (10.61%)	5 / 132 (3.79%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intrapartum haemorrhage
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oligohydramnios
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Preterm premature rupture of membranes
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature labour
subjects affected / exposed	4 / 113 (3.54%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Premature baby
subjects affected / exposed	0 / 113 (0.00%)	5 / 66 (7.58%)	14 / 132 (10.61%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	7 / 113 (6.19%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences causally related to treatment / all	0 / 7	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Postpartum haemorrhage
subjects affected / exposed	4 / 113 (3.54%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Placenta praevia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retained placenta or membranes
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small for dates baby
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vasa praevia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord prolapse
subjects affected / exposed	3 / 113 (2.65%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Threatened labour
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Superimposed pre-eclampsia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death neonatal
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
Pyrexia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
ABO incompatibility
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchopulmonary dysplasia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Apnoea
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	4 / 132 (3.03%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory distress syndrome
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	5 / 132 (3.79%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Neonatal respiratory distress
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal tachypnoea
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Foetal monitoring abnormal
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Medical observation
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Fibromatosis colli of infancy
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemangioma congenital
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Newborn persistent pulmonary hypertension
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cytogenetic abnormality
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital inguinal hernia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital arterial malformation
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial septal defect
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pectus excavatum
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ankyloglossia congenital
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary valve stenosis congenital
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular septal defect
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Bradycardia foetal
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary valve stenosis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foetal heart rate deceleration abnormality
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tachycardia foetal
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Poor sucking reflex
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Normochromic normocytic anaemia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Dysphagia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intussusception
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Dysentery
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Candida sepsis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis neonatal
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	6 / 132 (4.55%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 113 (0.88%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endometritis
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypoglycaemia neonatal
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	RSV_MAT Group-Mother	Control Group-Infant	RSV_MAT Group-Infant	Control Group-Mother
Total subjects affected by non serious adverse events
subjects affected / exposed	89 / 113 (78.76%)	57 / 66 (86.36%)	118 / 132 (89.39%)	38 / 56 (67.86%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Vascular disorders
Hypotension
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Surgical and medical procedures
Medically induced preterm birth
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	1	0	0	1
Labial frenectomy
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Pregnancy, puerperium and perinatal conditions
Premature labour
subjects affected / exposed	2 / 113 (1.77%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	2	0	0	1
Postpartum haemorrhage
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	1	0	0	1
Uterine atony
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences all number	0	0	0	2
False labour
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Foetal hypokinesia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Gestational diabetes
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Gestational hypertension
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Pre-eclampsia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Foetal growth restriction
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Small for dates baby
subjects affected / exposed	0 / 113 (0.00%)	14 / 66 (21.21%)	16 / 132 (12.12%)	0 / 56 (0.00%)
occurrences all number	0	14	16	0
Low birth weight baby
subjects affected / exposed	0 / 113 (0.00%)	10 / 66 (15.15%)	17 / 132 (12.88%)	0 / 56 (0.00%)
occurrences all number	0	10	17	0
Premature baby
subjects affected / exposed	0 / 113 (0.00%)	8 / 66 (12.12%)	10 / 132 (7.58%)	0 / 56 (0.00%)
occurrences all number	0	8	10	0
Jaundice neonatal
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	7 / 132 (5.30%)	0 / 56 (0.00%)
occurrences all number	0	3	7	0
Cephalhaematoma
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	3	0	0
Shoulder dystocia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Large for dates baby
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	32 / 113 (28.32%)	0 / 66 (0.00%)	0 / 132 (0.00%)	15 / 56 (26.79%)
occurrences all number	32	0	0	15
Administration site erythema
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Administration site swelling
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Injection site bruising
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Administration site pain
subjects affected / exposed	50 / 113 (44.25%)	0 / 66 (0.00%)	0 / 132 (0.00%)	8 / 56 (14.29%)
occurrences all number	50	0	0	8
Developmental delay
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Crying
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Pyrexia
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	2	4	0
Immune system disorders
Allergy to arthropod bite
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Milk allergy
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Reproductive system and breast disorders
Breast pain
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Testicular swelling
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Balanoposthitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Rhinitis allergic
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Respiratory distress
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Meconium aspiration syndrome
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Bronchospasm
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Respiratory disorder
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	2	1	0
Rhinorrhoea
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	2	4	0
Cough
subjects affected / exposed	0 / 113 (0.00%)	6 / 66 (9.09%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	7	2	0
Nasal congestion
subjects affected / exposed	0 / 113 (0.00%)	9 / 66 (13.64%)	15 / 132 (11.36%)	0 / 56 (0.00%)
occurrences all number	0	10	16	0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Investigations
Haematocrit decreased
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Haemoglobin decreased
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Cardiac murmur
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	1	2	0
Body height below normal
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Breath sounds abnormal
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Injury, poisoning and procedural complications
Seroma
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Clavicle fracture
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Concussion
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Post procedural complication
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Skin abrasion
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Congenital, familial and genetic disorders
Congenital central nervous system anomaly
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Congenital umbilical hernia
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	4 / 132 (3.03%)	0 / 56 (0.00%)
occurrences all number	0	4	4	0
Ankyloglossia congenital
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	4 / 132 (3.03%)	0 / 56 (0.00%)
occurrences all number	0	0	4	0
Congenital skin dimples
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Cryptorchism
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Haemangioma congenital
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Naevus flammeus
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Patent ductus arteriosus
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Talipes
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Congenital inguinal hernia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Cardiac disorders
Tachycardia
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	46 / 113 (40.71%)	0 / 66 (0.00%)	0 / 132 (0.00%)	21 / 56 (37.50%)
occurrences all number	46	0	0	21
Migraine
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Hypotonia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Intraventricular haemorrhage neonatal
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Anaemia
subjects affected / exposed	1 / 113 (0.88%)	1 / 66 (1.52%)	1 / 132 (0.76%)	1 / 56 (1.79%)
occurrences all number	1	1	1	1
Hypochromic anaemia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Ear pain
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Eye disorders
Dacryostenosis acquired
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Retinopathy of prematurity
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	23 / 113 (20.35%)	0 / 66 (0.00%)	2 / 132 (1.52%)	10 / 56 (17.86%)
occurrences all number	23	0	2	10
Nausea
subjects affected / exposed	28 / 113 (24.78%)	0 / 66 (0.00%)	0 / 132 (0.00%)	11 / 56 (19.64%)
occurrences all number	28	0	0	11
Diarrhoea
subjects affected / exposed	23 / 113 (20.35%)	1 / 66 (1.52%)	6 / 132 (4.55%)	4 / 56 (7.14%)
occurrences all number	24	1	6	4
Vomiting
subjects affected / exposed	9 / 113 (7.96%)	1 / 66 (1.52%)	0 / 132 (0.00%)	11 / 56 (19.64%)
occurrences all number	9	1	0	11
Dyspepsia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	2 / 56 (3.57%)
occurrences all number	0	0	0	2
Haemorrhoids
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Umbilical hernia
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Stomatitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Regurgitation
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	2	0	0
Eructation
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Flatulence
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	1	1	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	4	2	0
Constipation
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	6 / 132 (4.55%)	0 / 56 (0.00%)
occurrences all number	0	1	9	0
Hepatobiliary disorders
Cholestasis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	1	2	0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	1	1	0
Prurigo
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Rash
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	2	2	0
Dermatitis atopic
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	6	0	0
Eczema
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	4	4	0
Miliaria
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	8 / 132 (6.06%)	0 / 56 (0.00%)
occurrences all number	0	2	8	0
Dermatitis diaper
subjects affected / exposed	0 / 113 (0.00%)	7 / 66 (10.61%)	10 / 132 (7.58%)	0 / 56 (0.00%)
occurrences all number	0	11	11	0
Acne infantile
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Blister
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Cafe au lait spots
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Dry skin
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Intertrigo
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	2	2	0
Urticaria
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Renal and urinary disorders
Nephrocalcinosis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
Neck pain
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Back pain
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Acquired plagiocephaly
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	2	0	0
Joint laxity
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Joint noise
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	3 / 113 (2.65%)	20 / 66 (30.30%)	38 / 132 (28.79%)	4 / 56 (7.14%)
occurrences all number	3	83	123	5
COVID-19
subjects affected / exposed	5 / 113 (4.42%)	4 / 66 (6.06%)	4 / 132 (3.03%)	1 / 56 (1.79%)
occurrences all number	5	4	4	1
Urinary tract infection
subjects affected / exposed	2 / 113 (1.77%)	1 / 66 (1.52%)	1 / 132 (0.76%)	1 / 56 (1.79%)
occurrences all number	2	1	1	1
Nasopharyngitis
subjects affected / exposed	1 / 113 (0.88%)	11 / 66 (16.67%)	25 / 132 (18.94%)	0 / 56 (0.00%)
occurrences all number	1	24	62	0
Respiratory tract infection
subjects affected / exposed	2 / 113 (1.77%)	1 / 66 (1.52%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	2	1	3	0
Bacterial disease carrier
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Bacterial vaginosis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Mastitis
subjects affected / exposed	1 / 113 (0.88%)	0 / 66 (0.00%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 113 (0.88%)	7 / 66 (10.61%)	15 / 132 (11.36%)	1 / 56 (1.79%)
occurrences all number	1	11	17	1
Sinusitis
subjects affected / exposed	1 / 113 (0.88%)	2 / 66 (3.03%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	1	2	0	0
Vaginal infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	0 / 132 (0.00%)	1 / 56 (1.79%)
occurrences all number	0	0	0	1
Otitis media
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	6 / 132 (4.55%)	0 / 56 (0.00%)
occurrences all number	0	4	6	0
Bronchiolitis
subjects affected / exposed	0 / 113 (0.00%)	7 / 66 (10.61%)	22 / 132 (16.67%)	0 / 56 (0.00%)
occurrences all number	0	10	29	0
Lower respiratory tract infection
subjects affected / exposed	0 / 113 (0.00%)	9 / 66 (13.64%)	6 / 132 (4.55%)	0 / 56 (0.00%)
occurrences all number	0	10	8	0
Rhinitis
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	10 / 132 (7.58%)	0 / 56 (0.00%)
occurrences all number	0	5	10	0
Conjunctivitis
subjects affected / exposed	0 / 113 (0.00%)	4 / 66 (6.06%)	4 / 132 (3.03%)	0 / 56 (0.00%)
occurrences all number	0	5	4	0
Pharyngotonsillitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	1	1	0
Oral candidiasis
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	6 / 132 (4.55%)	0 / 56 (0.00%)
occurrences all number	0	2	8	0
Suspected COVID-19
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	5 / 132 (3.79%)	0 / 56 (0.00%)
occurrences all number	0	2	5	0
Otitis media acute
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	3	3	0
Bronchitis
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	2	4	0
Influenza
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	1	3	0
Fungal skin infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	0	3	0
Impetigo
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	0	3	0
Pneumonia
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	3 / 132 (2.27%)	0 / 56 (0.00%)
occurrences all number	0	0	3	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	2	1	0
Candida nappy rash
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Epstein-Barr virus infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Gastroenteritis viral
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Laryngitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Ear infection
subjects affected / exposed	0 / 113 (0.00%)	3 / 66 (4.55%)	5 / 132 (3.79%)	0 / 56 (0.00%)
occurrences all number	0	3	8	0
Tracheobronchitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	1	1	0
Pulmonary tuberculosis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Acute sinusitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Body tinea
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Bullous impetigo
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Candida infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Coxsackie viral infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Dacryocystitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Eye infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Norovirus infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Ophthalmia neonatorum
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Otitis externa
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Postoperative wound infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Acarodermatitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Pyelonephritis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Pyoderma
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Rhinovirus infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Skin candida
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Subcutaneous abscess
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Tonsillitis
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Typhoid fever
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Varicella
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Viral infection
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Metabolism and nutrition disorders
Underweight
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Lactose intolerance
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	0 / 132 (0.00%)	0 / 56 (0.00%)
occurrences all number	0	1	0	0
Hypoglycaemia neonatal
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	0	1	0
Weight gain poor
subjects affected / exposed	0 / 113 (0.00%)	0 / 66 (0.00%)	2 / 132 (1.52%)	0 / 56 (0.00%)
occurrences all number	0	0	2	0
Failure to thrive
subjects affected / exposed	0 / 113 (0.00%)	1 / 66 (1.52%)	1 / 132 (0.76%)	0 / 56 (0.00%)
occurrences all number	0	1	1	0
Hypoglycaemia
subjects affected / exposed	0 / 113 (0.00%)	2 / 66 (3.03%)	4 / 132 (3.03%)	0 / 56 (0.00%)
occurrences all number	0	2	4	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

15 Mar 2022

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 participants at that time continued to be monitored as part of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of maternal participants reporting any solicited administration site events

Primary: Percentage of maternal participants reporting any solicited administration site events

Primary: Percentage of maternal participants reporting any solicited systemic events

Primary: Percentage of maternal participants reporting any solicited systemic events

Primary: Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting any unsolicited adverse events (AEs)

Primary: Percentage of maternal participants reporting any unsolicited adverse events (AEs)

Primary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery

Primary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery

Primary: 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

Primary: 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

Primary: Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery

Primary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery

Primary: Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 42 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 180 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 180 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 365 days post-birth

Primary: Percentage of infant participants reporting MAEs from birth up to 365 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth

Primary: Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth

Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth

Primary: RSV MAT IgG-specific antibody concentrations for maternal participants at delivery

Primary: RSV MAT IgG-specific antibody concentrations for maternal participants at delivery

Primary: RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1)

Primary: RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1)

Primary: RSV-A neutralizing titers for maternal participants at delivery

Primary: RSV-A neutralizing titers for maternal participants at delivery

Primary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1)

Primary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1)

Primary: RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth

Primary: RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth

Primary: Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations

Primary: Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations

Primary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

Primary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

Secondary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery

Secondary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery

Secondary: Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery

Secondary: Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery

Secondary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery

Secondary: Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth

Secondary: Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth

Secondary: 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

Secondary: 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

Secondary: RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing

Secondary: RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing

Secondary: RSV-A neutralizing titers for maternal participants at Day 31 post-dosing

Secondary: RSV-A neutralizing titers for maternal participants at Day 31 post-dosing

Secondary: RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery