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Clinical Trial Results:
A Phase II, randomised, observer-blind, placebo controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV Maternal unadjuvanted vaccine (GSK3888550A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers

Summary
EudraCT number	2019-001991-12
Trial protocol	FI FR GB ES
Global end of trial date	14 May 2021

Results information
Results version number	v1(current)
This version publication date	29 Nov 2021
First version publication date	29 Nov 2021
Other versions

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

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Trial information

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Sponsor protocol code

209544

ISRCTN number

US NCT number

NCT04126213

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

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

Public contact

GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.com

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

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

23 Sep 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 Jul 2020

Global end of trial reached?

Yes

Global end of trial date

14 May 2021

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals’ investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

Protection of trial subjects

Maternal subjects were observed closely for at least 60 minutes after administration of the study vaccine/product. Appropriate medical treatment was readily available in case of anaphylaxis and syncope. Vaccines were administered by qualified and trained personnel. Infants and mothers were kept under surveillance and evaluation through 12 and 6 months post- delivery, respectively.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Nov 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 16

Country: Number of subjects enrolled

Canada: 11

Country: Number of subjects enrolled

Finland: 34

Country: Number of subjects enrolled

France: 6

Country: Number of subjects enrolled

New Zealand: 39

Country: Number of subjects enrolled

Panama: 72

Country: Number of subjects enrolled

South Africa: 13

Country: Number of subjects enrolled

Spain: 59

Country: Number of subjects enrolled

United States: 284

Worldwide total number of subjects

534

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

198

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

328

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 42 centers in 9 countries (Australia, Canada, Finland, France, New Zealand, Panama, South Africa, Spain, United States).

Screening details

Out of 534 participants who signed the informed consent 213 maternal subjects were vaccinated, and 206 infants were born to those exposed mothers. Therefore, a total of 419 are considered exposed.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Assessor

Blinding implementation details

The overall study design was observer-blind. The study staff administering the vaccine was unblinded.

Are arms mutually exclusive

Yes

RSV MAT 60 Group-Mother

Arm description

Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.

Arm type

Experimental

Investigational medicinal product name

RSV MAT 60 µg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection, Powder for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

RSV MAT 120 Group-Mother

Arm description

Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.

Arm type

Experimental

Investigational medicinal product name

RSV MAT 120 µg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection, Powder for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Control Group-Mother

Arm description

Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

RSV MAT 60 Group-Infant

Arm description

This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

RSV MAT 120 Group-Infant

Arm description

This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) 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 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Started	70	75	68	67	73	66
Completed	58	70	59	54	67	55
Not completed	12	5	9	13	6	11
Consent withdrawn by subject	3	2	1	1	1	1
MIGRATED / MOVED FROM THE STUDY AREA	-	2	1	-	1	2
Lost to follow-up	9	1	5	10	4	7
UNSPECIFIED	-	-	2	2	-	1

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 534 participants who signed the informed consent 213 maternal subjects were vaccinated, and 206 infants were born to those exposed mothers. Therefore, a total of 419 are considered exposed.

Baseline characteristics

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Reporting group title

RSV MAT 60 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 120 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

Control Group-Mother

Reporting group description

Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 60 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.

Reporting group title

RSV MAT 120 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) 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 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant	Total
Number of subjects	70	75	68	67	73	66	419
Age Categorical
Units: Participants
0 to 1 years	0	0	0	67	73	66	206
18 < 35 years	59	62	56	0	0	0	177
>= 35 years	11	13	12	0	0	0	36
Sex: Female, Male
Units: Participants
Female	70	75	68	28	30	37	308
Male	0	0	0	39	43	29	111
Race/Ethnicity, Customized
Units: Subjects
AMERICAN INDIAN OR ALASKA NATIVE	0	2	0	0	1	0	3
ASIAN	0	0	2	0	0	1	3
BLACK OR AFRICAN AMERICAN	12	12	13	12	9	9	67
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	3	1	0	3	2	1	10
OTHER	10	10	7	10	11	8	56
UNKNOWN	0	2	1	0	1	1	5
WHITE	45	48	45	42	49	46	275

End points

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Reporting group title

RSV MAT 60 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 120 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

Control Group-Mother

Reporting group description

Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 60 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.

Reporting group title

RSV MAT 120 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) 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 60 Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group consisted of pairs of maternal subjects from RSV MAT 60- Mother Group and infant subjects from RSV MAT 60-Infants Group.

Subject analysis set title

RSV MAT 120 Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group consisted of pairs of maternal subjects from RSV MAT 120- Mother Group and infant subjects from RSV MAT 120-Infants Group.

Subject analysis set title

Control Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

This group consisted of pairs of maternal subjects from Control- Mother Group and infant subjects from Control-Infants Group.

Primary: Percentage of maternal subjects with any solicited administration site events

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End point title

Percentage of maternal subjects with any solicited administration site events ^[1] ^[2]

End point description

Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

End point type

Primary

End point timeframe

During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	66
Units: Percentage of maternal subjects
number (confidence interval 95%)
Any Pain (N=70,75,66)	57.1 (44.7 to 68.9)	52 (40.2 to 63.7)	15.2 (7.5 to 26.1)
Any Erythema (N=70,75,66)	1.4 (0 to 7.7)	6.7 (2.2 to 14.9)	0 (0 to 5.4)
Any Swelling (N=70,75,66)	4.3 (0.9 to 12)	4 (0.8 to 11.2)	0 (0 to 5.4)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with any solicited systemic events

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End point title

Percentage of maternal subjects with any solicited systemic events ^[3] ^[4]

End point description

Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever [temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

End point type

Primary

End point timeframe

During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	66
Units: Percentage of maternal subjects
number (confidence interval 95%)
Any Fatigue (N=70,75,66)	40 (28.5 to 52.4)	34.7 (24 to 46.5)	25.8 (15.8 to 38)
Any Headache (N=70,75,66)	34.3 (23.3 to 46.6)	28 (18.2 to 39.6)	19.7 (10.9 to 31.3)
Any Nausea (N=70,75,66)	25.7 (16 to 37.6)	22.7 (13.8 to 33.8)	13.6 (6.4 to 24.3)
Any Vomiting (N=70,75,66)	7.1 (2.4 to 15.9)	9.3 (3.8 to 18.3)	4.5 (0.9 to 12.7)
Any Diarrhea (N=70,75,66)	14.3 (7.1 to 24.7)	17.3 (9.6 to 27.8)	13.6 (6.4 to 24.3)
Any Abdominal pain (N=70,75,66)	12.9 (6.1 to 23)	22.7 (13.8 to 33.8)	9.1 (3.4 to 18.7)
Any Fever (N=70,75,66)	0 (0 to 5.1)	0 (0 to 4.8)	0 (0 to 5.4)

No statistical analyses for this end point

Primary: Number of maternal subjects with any haematological laboratory abnormalities at Day 8 by baseline ranges

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End point title

Number of maternal subjects with any haematological laboratory abnormalities at Day 8 by baseline ranges ^[5] ^[6]

End point description

[4:07 PM] Cornelia Ungurean Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. ‘WBC decrease Below (B) – Within (D8)’ = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.

End point type

Primary

End point timeframe

At Day 8

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Participants
EOS Increase Below (B)-Below (D8) (N=70,75,68)	6	5	2
EOS Increase Below (B)-Within (D8) (N=70,75,68)	6	2	4
EOS Increase Below (B)-Above (D8) (N=70,75,68)	0	0	0
EOS Increase Below (B)-Unknown (D8) (N=70,75,68)	0	0	1
EOS Increase Within (B)-Below (D8) (N=70,75,68)	2	5	2
EOS Increase Within (B)-Within (D8) (N=70,75,68)	53	58	56
EOS Increase Within (B)-Above (D8) (N=70,75,68)	0	0	0
EOS Increase Within (B)-Unknown (D8) (N=70,75,68)	2	3	1
EOS Increase Above (B)-Below (D8) (N=70,75,68)	0	0	0
EOS Increase Above (B)-Within (D8) (N=70,75,68)	0	1	0
EOS Increase Above (B)-Above (D8) (N=70,75,68)	1	1	0
EOS Increase, Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
EOS Increase Unknown (B)-Below (D8) (N=70,75,68)	0	0	0
EOS Increase Unknown (B)-Within (D8) (N=70,75,68)	0	0	2
EOS Increase Unknown (B)-Above (D8) (N=70,75,68)	0	0	0
EOS Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
ERY Decrease, Below (B)-Below (D8)(N=70,75,68)	24	35	23
ERY Decrease Below (B)-Within (D8)(N=70,75,68)	4	2	5
ERY Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
ERY Decrease Below (B)-Unknown (D8)(N=70,75,68)	1	2	2
ERY Decrease Within (B)-Below (D8)(N=70,75,68)	6	2	7
ERY Decrease Within (B)-Within (D8)(N=70,75,68)	34	34	29
ERY Decrease Within (B)-Above (D8)(N=70,75,68)	0	0	0
ERY Decrease Within(B)-Unknown (D8)(N=70,75,68)	1	0	0
ERY Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
ERY Decrease Above (B)-Within (D8)(N=70,75,68)	0	0	0
ERY Decrease Above (B)-Above (D8)(N=70,75,68)	0	0	0
ERY Decrease Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
ERY Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	2
ERY Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	0
ERY Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
ERY Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
ERY Increase Below (B)-Below (D8) (N=70,75,68)	24	35	23
ERY Increase Below (B)-Within (D8) (N=70,75,68)	4	2	5
ERY Increase Below (B)-Above (D8) (N=70,75,68)	0	0	0
ERY Increase Below (B)-Unknown (D8) (N=70,75,68)	1	2	2
ERY Increase Within (B)-Below (D8) (N=70,75,68)	6	2	7
ERY Increase Within (B)-Within (D8) (N=70,75,68)	34	34	29
ERY Increase Within (B)-Above (D8) (N=70,75,68)	0	0	0
ERY Increase Within (B)-Unknown (D8) (N=70,75,68)	1	0	0
ERY Increase Above (B)-Below (D8) (N=70,75,68)	0	0	0
ERY Increase Above (B)-Within (D8) (N=70,75,68)	0	0	0
ERY Increase Above (B)-Above (D8) (N=70,75,68)	0	0	0
ERY Increase Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
ERY Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	2
ERY Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	0
ERY Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
ERY Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
HEM Decrease Below (B)-Below (D8)(N=70,75,68)	25	26	24
HEM Decrease Below (B)-Within (D8)(N=70,75,68)	2	3	2
HEM Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Decrease Below (B)-Unknown (D8)(N=70,75,68)	1	1	1
HEM Decrease Within (B)-Below (D8)(N=70,75,68)	7	9	7
HEM Decrease Within (B)-Within (D8)(N=70,75,68)	34	35	31
HEM Decrease Within (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Decrease Within (B)-Unknown (D8)(N=70,75,68)	1	1	1
HEM Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
HEM Decrease Above (B)-Within (D8)(N=70,75,68)	0	0	0
HEM Decrease Above (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Decrease Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
HEM Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	2
HEM Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	0
HEM Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
HEM Increase Below (B)-Below (D8) (N=70,75,68)	25	26	24
HEM Increase Below (B)-Within (D8)(N=70,75,68)	2	3	2
HEM Increase, Below (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Increase Below (B)-Unknown (D8)(N=70,75,68)	1	1	1
HEM Increase Within (B)-Below (D8)(N=70,75,68)	7	9	7
HEM Increase Within (B)-Within (D8)(N=70,75,68)	34	35	31
HEM Increase Within (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Increase Within (B)-Unknown (D8)(N=70,75,68)	1	1	1
HEM Increase Above (B)-Below (D8)(N=70,75,68)	0	0	0
HEM Increase Above (B)-Within (D8)(N=70,75,68)	0	0	0
HEM Increase Above (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Increase Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
HEM Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	2
HEM Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	0
HEM Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
HEM Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Decrease Below (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Decrease Below (B)-Within (D8)(N=70,75,68)	0	0	1
LYMP Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Decrease Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Decrease Within (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Decrease Within (B)-Within (D8)(N=70,75,68)	68	72	63
LYMP Decrease Within (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Decrease Within (B)-Unknown (D8)(N=70,75,68)	2	3	2
LYMP Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Decrease Above (B)-Within (D8)(N=70,75,68)	0	0	0
LYMP Decrease Above (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Decrease Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
LYMP Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Increase Below (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Increase Below (B)-Within (D8)(N=70,75,68)	0	0	1
LYMP Increase Below (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Increase Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Increase Within (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Increase Within (B)-Within (D8)(N=70,75,68)	68	72	63
LYMP Increase Within (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Increase Within (B)-Unknown (D8)(N=70,75,68)	2	3	2
LYMP Increase Above (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Increase Above (B)-Within (D8)(N=70,75,68)	0	0	0
LYMP Increase Above (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Increase Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
LYMP Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
LYMP Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
LYMP Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
LYMP Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
MCV Decrease Below (B)-Below (D8)(N=70,75,68)	2	1	1
MCV Decrease Below (B)-Within (D8)(N=70,75,68)	0	0	0
MCV Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
MCV Decrease Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
MCV Decrease Within (B)-Below (D8)(N=70,75,68)	0	0	1
MCV Decrease Within (B)-Within (D8)(N=70,75,68)	62	66	57
MCV Decrease Within (B)-Above (D8)(N=70,75,68)	2	2	1
MCV Decrease Within (B)-Unknown (D8)(N=70,75,68)	2	1	2
MCV Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
MCV Decrease Above (B)-Within (D8)(N=70,75,68)	0	2	1
MCV Decrease Above (B)-Above (D8)(N=70,75,68)	2	2	3
MCV Decrease Above (B)-Unknown (D8)(N=70,75,68)	0	1	0
MCV Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
MCV Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
MCV Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
MCV Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
MCV Increase Below (B)-Below (D8)(N=70,75,68)	2	1	1
MCV Increase Below (B)-Within (D8)(N=70,75,68)	0	0	0
MCV Increase Below (B)-Above (D8)(N=70,75,68)	0	0	0
MCV Increase Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
MCV Increase Within (B)-Below (D8)(N=70,75,68)	0	0	1
MCV Increase Within (B)-Within (D8)(N=70,75,68)	62	66	57
MCV Increase Within (B)-Above (D8)(N=70,75,68)	2	2	1
MCV Increase Within (B)-Unknown (D8)(N=70,75,68)	2	1	2
MCV Increase Above (B)-Below (D8)(N=70,75,68)	0	0	0
MCV Increase Above (B)-Within (D8)(N=70,75,68)	0	2	1
MCV Increase Above (B)-Above (D8)(N=70,75,68)	2	2	3
MCV Increase Above (B)-Unknown (D8)(N=70,75,68)	0	1	0
MCV Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
MCV Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
MCV Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
MCV Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
NEU Decrease Below (B)-Below (D8) (N=70,75,68)	0	0	0
NEU Decrease Below (B)-Within (D8)(N=70,75,68)	0	0	0
NEU Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
NEU Decrease Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
NEU Decrease Within (B)-Below (D8)(N=70,75,68)	0	0	0
NEU Decrease Within (B)-Within (D8)(N=70,75,68)	42	46	41
NEU Decrease Within (B)-Above (D8)(N=70,75,68)	8	9	9
NEU Decrease Within (B)-Unknown (B)(N=70,75,68)	0	2	1
NEU Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
NEU Decrease Above (B)-Within (D8)(N=70,75,68)	5	5	6
NEU Decrease Above (B)-Above (D8)(N=70,75,68)	13	12	8
NEU Decrease Above (B)-Unknown (D8)(N=70,75,68)	2	1	1
NEU Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
NEU Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	1
NEU Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	1
NEU Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
PLA Decrease Below (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Decrease Below (B)-Within (D8)(N=70,75,68)	1	1	0
PLA Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
PLA Decrease Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
PLA Decrease Within (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Decrease Within (B)-Within (D8)(N=70,75,68)	67	72	63
PLA Decrease Within (B)-Above (D8)(N=70,75,68)	0	0	0
PLA Decrease Within (B)-Unknown (D8)(N=70,75,68)	2	2	2
PLA Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Decrease Above (B)-Within (D8)(N=70,75,68)	0	0	1
PLA Decrease Above (B)-Above (D8)(N=70,75,68)	0	0	0
PLA Decrease Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
PLA Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
PLA Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
PLA Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
PLA Increase Below (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Increase Below (B)-Within (D8) (N=70,75,68)	1	1	0
PLA Increase Below (B)-Above (D8) (N=70,75,68)	0	0	0
PLA Increase Below (B)-Unknown (D8) (N=70,75,68)	0	0	0
PLA Increase Within (B)-Below (D8) (N=70,75,68)	0	0	0
PLA Increase Within (B)-Within (D8) (N=70,75,68)	67	72	63
PLA Increase Within (B)-Above (D8) (N=70,75,68)	0	0	0
PLA Increase Within (B)-Unknown (D8) (N=70,75,68)	2	2	2
PLA Increase Above (B)-Below (D8) (N=70,75,68)	0	0	0
PLA Increase Above (B)-Within (D8) (N=70,75,68)	0	0	1
PLA Increase Above (B)-Above (D8) (N=70,75,68)	0	0	0
PLA Increase Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
PLA Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
PLA Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	2
PLA Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
PLA Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
WBC Decrease Below (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Decrease Below (B)-Within (D8)(N=70,75,68)	0	0	0
WBC Decrease Below (B)-Above (D8)(N=70,75,68)	0	0	0
WBC Decrease Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
WBC Decrease Within (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Decrease Within (B)-Within (D8)(N=70,75,68)	46	48	46
WBC Decrease Within (B)-Above (D8)(N=70,75,68)	5	8	5
WBC Decrease Within (B)-Unknown (D8)(N=70,75,68)	1	1	2
WBC Decrease Above (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Decrease Above (B)-Within (D8)(N=70,75,68)	3	5	3
WBC Decrease Above (B)-Above (D8)(N=70,75,68)	14	12	10
WBC Decrease Above (B)-Unknown (D8)(N=70,75,68)	1	1	0
WBC Decrease Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Decrease Unknown (B)-Within (D8)(N=70,75,68)	0	0	1
WBC Decrease Unknown (B)-Above (D8)(N=70,75,68)	0	0	1
WBC Decrease Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0
WBC Increase Below (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Increase Below (B)-Within (D8)(N=70,75,68)	0	0	0
WBC Increase Below (B)-Above (D8)(N=70,75,68)	0	0	0
WBC Increase Below (B)-Unknown (D8)(N=70,75,68)	0	0	0
WBC Increase Within (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Increase Within (B)-Within (D8)(N=70,75,68)	46	48	46
WBC Increase Within (B)-Above (D8)(N=70,75,68)	5	8	5
WBC Increase Within (B)-Unknown (D8)(N=70,75,68)	1	1	2
WBC Increase Above (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Increase Above (B)-Within (D8)(N=70,75,68)	3	5	3
WBC Increase Above (B)-Above (D8)(N=70,75,68)	14	12	10
WBC Increase Above (B)-Unknown (D8)(N=70,75,68)	1	1	0
WBC Increase Unknown (B)-Below (D8)(N=70,75,68)	0	0	0
WBC Increase Unknown (B)-Within (D8)(N=70,75,68)	0	0	1
WBC Increase Unknown (B)-Above (D8)(N=70,75,68)	0	0	1
WBC Increase Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0

No statistical analyses for this end point

Primary: Number of maternal subjects with any biochemical laboratory abnormalities at Day 8 by baseline ranges

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End point title

Number of maternal subjects with any biochemical laboratory abnormalities at Day 8 by baseline ranges ^[7] ^[8]

End point description

[4:07 PM] Cornelia Ungurean Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. ‘AST increase Below (B) – Within (D8)’ = AST increase in subjects with below normal values at baseline and within normal values at Day 8.

End point type

Primary

End point timeframe

At Day 8

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Participants
ALT increase Below (B)-Below (D8)(N=70,75,68)	0	0	0
ALT increase Below (B)- Within (D8)(N=70,75,68)	0	0	0
ALT increase Below (B)- Above (D8) (N=70,75,68)	0	0	0
ALT increase Below (B)-Unknown (D8) (N=70,75,68)	0	0	0
ALT increase Within (B)- Below (D8) (N=70,75,68)	0	0	0
ALT increase Within (B)-Within (D8) (N=70,75,68)	64	69	65
ALT increase Within (B)- Above (D8)(N=70,75,68)	1	0	0
ALT increase Within (B)-Unknown (D8) (N=70,75,68)	2	3	1
ALT increase Above (B)- Below (D8)(N=70,75,68)	0	0	0
ALT increase Above (B)- Within (D8) (N=70,75,68)	1	2	0
ALT - increase Above (B)- Above (D8) (N=70,75,68)	1	1	0
ALT increase Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
ALT increase Unknown (B)-Below (D8) (N=70,75,68)	0	0	0
ALT increase Unknown (B)-Within (D8) (N=70,75,68)	1	0	2
ALT increase Unknown (B)-Above (D8) (N=70,75,68)	0	0	0
ALT increase Unknown (B)-Unknown (D8) (N=70,75,68)	0	0	0
AST increase Below (B)-Below (D8)(N=70,75,68)	0	0	0
AST increase Below (B)- Within (D8)(N=70,75,68)	0	0	0
AST increase Below (B)- Above (D8)(N=70,75,68)	0	0	0
AST increase Below (B)-Unknown (D8) (N=70,75,68)	0	0	0
AST increase Within (B)- Below (D8)(N=70,75,68)	0	0	0
AST increase Within (B)-Within (D8)(N=70,75,68)	67	71	65
AST increase Within (B)- Above (D8) (N=70,75,68)	0	1	0
AST increase Within (B)-Unknown (D8) (N=70,75,68)	1	2	1
AST increase Above (B)- Below (D8)(N=70,75,68)	0	0	0
AST increase Above (B)-Within (D8) (N=70,75,68)	0	1	0
AST increase Above (B)-Above (D8)(N=70,75,68)	1	0	0
AST increase Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
AST increase Unknown (B)-Below (D8) (N=70,75,68)	0	0	0
AST increase Unknown (B)-Within (D8) (N=70,75,68)	1	0	2
AST increase Unknown (B)-Above (D8) (N=70,75,68)	0	0	0
AST increase Unknown (B)-Unknown (D8) (N=70,75,68)	0	0	0
Creatinine Below (B)-Below (D8) (N=70,75,68)	16	18	18
Creatinine Below (B)-Within (D8) (N=70,75,68)	6	9	4
Creatinine Below (B)-Above (D8) (N=70,75,68)	0	0	0
Creatinine Below (B)- Unknown (D8) (N=70,75,68)	0	0	1
Creatinine Within (B)-Below (D8) (N=70,75,68)	2	4	6
Creatinine Within (B)-Within (D8) (N=70,75,68)	45	42	37
Creatinine Within (B)-Above (D8)(N=70,75,68)	0	0	0
Creatinine Within (B)-Unknown (D8) (N=70,75,68)	1	2	0
Creatinine Above (B)-Below (D8)(N=70,75,68)	0	0	0
Creatinine Above (B)-Within (D8)(N=70,75,68)	0	0	0
Creatinine Above (B)-Above (D8)(N=70,75,68)	0	0	0
Creatinine Above (B)-Unknown (D8)(N=70,75,68)	0	0	0
Creatinine Unknown (B)-Below (D8) (N=70,75,68)	0	0	1
Creatinine Unknown (B)-Within (D8) (N=70,75,68)	0	0	1
Creatinine Unknown (B)-Above (D8)(N=70,75,68)	0	0	0
Creatinine Unknown (B)-Unknown (D8) (N=70,75,68)	0	0	0
URN Below (B)- Below (D8)(N=70,75,68)	13	15	13
URN Below (B)-Within (D8) (N=70,75,68)	6	4	3
URN Below (B)-Above (D8) (N=70,75,68)	0	0	0
URN Below (B)-Unknown (D8)(N=70,75,68)	0	1	1
URN Within (B)-Below (D8) (N=70,75,68)	5	4	9
URN Within (B)-Within (D8) (N=70,75,68)	45	49	39
URN Within (B)-Above (D8) (N=70,75,68)	0	0	0
URN Within (B)-Unknown (D8) (N=70,75,68)	1	1	0
URN Above (B)-Below (D8)(N=70,75,68)	0	0	0
URN Above (B)-Within (D8) (N=70,75,68)	0	0	0
URN Above (B)-Above (D8) (N=70,75,68)	0	0	0
URN Above (B)-Unknown (D8) (N=70,75,68)	0	0	0
URN Unknown (B)-Below (D8) (N=70,75,68)	0	0	0
URN Unknown (B)-Within (D8) (N=70,75,68)	0	1	3
URN Unknown (B)-Above (D8) (N=70,75,68)	0	0	0
URN Unknown (B)-Unknown (D8)(N=70,75,68)	0	0	0

No statistical analyses for this end point

Primary: Percentage of maternal subjects with any unsolicited adverse events (AEs)

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End point title

Percentage of maternal subjects with any unsolicited adverse events (AEs) ^[9] ^[10]

End point description

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

End point type

Primary

End point timeframe

During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	30 (19.6 to 42.1)	33.3 (22.9 to 45.2)	33.8 (22.8 to 46.3)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with any serious adverse events (SAEs)

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End point title

Percentage of maternal subjects with any serious adverse events (SAEs) ^[11] ^[12]

End point description

SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

End point type

Primary

End point timeframe

From Day 1 to Day 43 post-delivery

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 maternal subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	22.9 (13.7 to 34.4)	26.7 (17.1 to 38.1)	22.1 (12.9 to 33.8)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with AEs leading to study withdrawal

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End point title

Percentage of maternal subjects with AEs leading to study withdrawal ^[13] ^[14]

End point description

An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.

End point type

Primary

End point timeframe

From Day 1 to Day 43 post-delivery

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with any medically attended AEs (MAE)

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End point title

Percentage of maternal subjects with any medically attended AEs (MAE) ^[15] ^[16]

End point description

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

End point type

Primary

End point timeframe

From Day 1 to Day 43 post-delivery

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	41.4 (29.8 to 53.8)	48 (36.3 to 59.8)	42.6 (30.7 to 55.2)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with pregnancy outcomes

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End point title

Percentage of maternal subjects with pregnancy outcomes ^[17] ^[18]

End point description

Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth (FD/SB) with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).

End point type

Primary

End point timeframe

From Day 1 to Day 43 post-delivery

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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)
Live birth, no congenital anomalies (N=70,75,68)	84.3 (73.6 to 91.9)	81.3 (70.7 to 89.4)	80.9 (69.5 to 89.4)
Live birth, congenital anomalies (N=70,75,68)	12.9 (6.1 to 23)	16 (8.6 to 26.3)	16.2 (8.4 to 27.1)
FD/SB, no CA- Antepartum (N=70,75,68)	0 (0 to 5.1)	0 (0 to 4.8)	1.5 (0 to 7.9)
Unknown (N=70,75,68)	2.9 (0.3 to 9.9)	2.7 (0.3 to 9.3)	1.5 (0 to 7.9)

No statistical analyses for this end point

Primary: Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs)

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End point title

Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs) ^[19] ^[20]

End point description

Pregnancy-related AESIs were: Non-Reassuring Fetal Status, Hypertensive Disorders of Pregnancy (HDP), Oligohydramnios, Pathways to Preterm Birth (PPB), Chorioamnionitis, Fetal Growth Restriction, Gestational Liver Disease (GLD)-Intrahepatic Cholestasis Of Pregnancy (ICP), Postpartum Haemorrhage and Gestational Diabetes Mellitus.

End point type

Primary

End point timeframe

From Day 1 to Day 43 post-delivery

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 maternal subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)
Non-Reassuring Fetal Status (N=70,75,68)	8.6 (3.2 to 17.7)	12 (5.6 to 21.6)	11.8 (5.2 to 21.9)
HDP-Gestational Hypertensions (N=70,75,68)	4.3 (0.9 to 12)	2.7 (0.3 to 9.3)	1.5 (0 to 7.9)
HDP-Pre-Eclampsias (N=70,75,68)	5.7 (1.6 to 14)	2.7 (0.3 to 9.3)	0 (0 to 5.3)
Oligohydramnioss (N=70,75,68)	4.3 (0.9 to 12)	2.7 (0.3 to 9.3)	1.5 (0 to 7.9)
PPB-Preterm Labors (N=70,75,68)	0 (0 to 5.1)	2.7 (0.3 to 9.3)	2.9 (0.4 to 10.2)
PPB-Preterm Rupture Of Membraness (N=70,75,68)	1.4 (0 to 7.7)	0 (0 to 4.8)	1.5 (0 to 7.9)
PPB-Provider-Initiated Preterm Births (N=70,75,68)	0 (0 to 5.1)	1.3 (0 to 7.2)	0 (0 to 5.3)
Chorioamnionitiss (N=70,75,68)	2.9 (0.3 to 9.9)	2.7 (0.3 to 9.3)	1.5 (0 to 7.9)
Fetal Growth Restrictions (N=70,75,68)	1.4 (0 to 7.7)	2.7 (0.3 to 9.3)	0 (0 to 5.3)
GLD-ICP (N=70,75,68)	2.9 (0.3 to 9.9)	1.3 (0 to 7.2)	0 (0 to 5.3)
Postpartum Haemorrhages (N=70,75,68)	1.4 (0 to 7.7)	0 (0 to 4.8)	1.5 (0 to 7.9)
Gestational Diabetes Mellituss (N=70,75,68)	1.4 (0 to 7.7)	0 (0 to 4.8)	0 (0 to 5.3)

No statistical analyses for this end point

Primary: Percentage of infant subjects with neonatal AESIs

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End point title

Percentage of infant subjects with neonatal AESIs ^[21] ^[22]

End point description

Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI): Bacterial/Fungal/Viral (B/F/V), Bacterial/Fungal/Viral Meningitis (B/F/VM), Respiratory Bacterial/Fungal/Viral Infection (B/F/VI), and Congenital Anomalies (CA).

End point type

Primary

End point timeframe

From birth to Day 43 post-birth

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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)
Respiratory Distress In The Neonate (N=67,73,66)	6 (1.7 to 14.6)	6.8 (2.3 to 15.3)	6.1 (1.7 to 14.8)
Macrosomia (N=67,73,66)	3 (0.4 to 10.4)	2.7 (0.3 to 9.5)	7.6 (2.5 to 16.8)
Low Birth Weight (N=67,73,66)	1.5 (0 to 8)	5.5 (1.5 to 13.4)	3 (0.4 to 10.5)
Small For Gestational Age (N=67,73,66)	3 (0.4 to 10.4)	4.1 (0.9 to 11.5)	3 (0.4 to 10.5)
Preterm Birth (N=67,73,66)	1.5 (0 to 8)	4.1 (0.9 to 11.5)	3 (0.4 to 10.5)
Large For Gestational Age (N=67,73,66)	3 (0.4 to 10.4)	0 (0 to 4.9)	4.5 (0.9 to 12.7)
NIBSI: B/F/V (N=67,73,66)	0 (0 to 5.4)	1.4 (0 to 7.4)	1.5 (0 to 8.2)
NIBSI: B/F/VM (N=67,73,66)	0 (0 to 5.4)	1.4 (0 to 7.4)	0 (0 to 5.4)
NIBSI: B/F/VI (N=67,73,66)	0 (0 to 5.4)	0 (0 to 4.9)	1.5 (0 to 8.2)
CA-Major External Structural Defects (N=67,73,66)	0 (0 to 5.4)	2.7 (0.3 to 9.5)	0 (0 to 5.4)
CA-Functional Defects (N=67,73,66)	0 (0 to 5.4)	1.4 (0 to 7.4)	0 (0 to 5.4)
CA-Internal Structural Defects (N=67,73,66)	0 (0 to 5.4)	1.4 (0 to 7.4)	0 (0 to 5.4)

No statistical analyses for this end point

Primary: Percentage of infant subjects with any SAEs

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End point title

Percentage of infant subjects with any SAEs ^[23] ^[24]

End point description

SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

End point type

Primary

End point timeframe

From birth to Day 43 post-birth

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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	22.4 (13.1 to 34.2)	27.4 (17.6 to 39.1)	28.8 (18.3 to 41.3)

No statistical analyses for this end point

Primary: Percentage of infant subjects with AEs leading to study withdrawal

Top of page

End point title

Percentage of infant subjects with AEs leading to study withdrawal ^[25] ^[26]

End point description

End point type

Primary

End point timeframe

From birth to Day 43 post-birth

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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Primary: Percentage of infant subjects with any MAEs

Top of page

End point title

Percentage of infant subjects with any MAEs ^[27] ^[28]

End point description

End point type

Primary

End point timeframe

From birth to Day 43 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	25.4 (15.5 to 37.5)	35.6 (24.7 to 47.7)	30.3 (19.6 to 42.9)

No statistical analyses for this end point

Primary: RSV MAT Immunoglobulin G (IgG)-specific antibody concentrations in terms of Geometric Mean Concentrations (GMCs) in maternal subjects

Top of page

End point title

RSV MAT Immunoglobulin G (IgG)-specific antibody concentrations in terms of Geometric Mean Concentrations (GMCs) in maternal subjects ^[29] ^[30]

End point description

Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.

End point type

Primary

End point timeframe

At Day 1 (before vaccination), Day 31 and at delivery

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 maternal subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	68	72	68
Units: EU/mL
geometric mean (confidence interval 95%)
Day 1 (N=68,72,68)	5681 (4851 to 6653)	5837 (4962 to 6865)	6147 (5224 to 7234)
Day 31 (N=58,68,60)	80986 (66746 to 98263)	105138 (93657 to 118025)	6597 (5252 to 8288)
Delivery (N=64,67,62)	59395 (50742 to 69524)	59715 (51417 to 69352)	5555 (4568 to 6755)

No statistical analyses for this end point

Primary: RSV-A neutralizing antibody Geometric Mean Titers (GMTs) in maternal subjects

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End point title

RSV-A neutralizing antibody Geometric Mean Titers (GMTs) in maternal subjects ^[31] ^[32]

End point description

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.

End point type

Primary

End point timeframe

At Day 1 (before vaccination), Day 31 and at delivery

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 maternal subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	68	73	68
Units: Titers
geometric mean (confidence interval 95%)
Day 1 (N=68,73,68)	671.8 (544.1 to 829.4)	694.7 (565.8 to 852.9)	735.6 (586.7 to 922.1)
Day 31 (N=58,68,60)	9534.2 (7758.5 to 11716.3)	10781.2 (9150 to 12703.2)	799.1 (622.2 to 1026.2)
Delivery (N=64,67,62)	6162.1 (4981.2 to 7623)	6661 (5490.7 to 8080.7)	761.1 (612.1 to 946.3)

No statistical analyses for this end point

Primary: RSV MAT IgG antibody GMCs in infants born to maternal subjects

Top of page

End point title

RSV MAT IgG antibody GMCs in infants born to maternal subjects ^[33] ^[34]

End point description

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).

End point type

Primary

End point timeframe

At delivery or within 3 days after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	59	64	60
Units: EU/mL
geometric mean (confidence interval 95%)	91606.9 (76414.1 to 109820.3)	114529.8 (100023.3 to 131140.1)	9272.3 (7669.8 to 11209.5)

No statistical analyses for this end point

Primary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects

Top of page

End point title

RSV-A neutralizing antibody GMTs in infants born to maternal subjects ^[35] ^[36]

End point description

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).

End point type

Primary

End point timeframe

At delivery or within 3 days after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	60	64	61
Units: Titers
geometric mean (confidence interval 95%)	8414.7 (6813.4 to 10392.5)	10262.5 (8709.9 to 12091.9)	1244.7 (981.3 to 1578.8)

No statistical analyses for this end point

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

Top of page

End point title

Geometric Mean Ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations ^[37]

End point description

The placental transfer ratio of IgG specific antibody concentration was determined from cord blood (or blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The analysis was performed on all pairs of maternal subjects (from PPSM) and their infants (from PPSI) with available results for this outcome measure at the specified time point.

End point type

Primary

End point timeframe

At delivery (for maternal subjects) or within 3 days after birth (for infants)

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.

End point values	RSV MAT 60 Group	RSV MAT 120 Group	Control Group
Number of subjects analysed	59	63	58
Units: Ratio
geometric mean (confidence interval 95%)	1.62 (1.44 to 1.82)	1.9 (1.75 to 2.06)	1.6 (1.47 to 1.75)

No statistical analyses for this end point

Secondary: Percentage of maternal subjects with any SAE from Day 1 to Day 181 post delivery

Top of page

End point title

Percentage of maternal subjects with any SAE from Day 1 to Day 181 post delivery ^[38]

End point description

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[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 maternal subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	22.9 (13.7 to 34.4)	28 (18.2 to 39.6)	22.1 (12.9 to 33.8)

No statistical analyses for this end point

Secondary: Percentage of maternal subjects with any MAE from Day 1 to Day 181 post delivery

Top of page

End point title

Percentage of maternal subjects with any MAE from Day 1 to Day 181 post delivery ^[39]

End point description

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[39] - 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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	47.1 (35.1 to 59.4)	53.3 (41.4 to 64.9)	47.1 (34.8 to 59.6)

No statistical analyses for this end point

Secondary: Percentage of maternal subjects with AE leading to study withdrawal from Day 1 to Day 181 post delivery

Top of page

End point title

Percentage of maternal subjects with AE leading to study withdrawal from Day 1 to Day 181 post delivery ^[40]

End point description

End point type

Secondary

End point timeframe

From Day 1 to Day 181 post-delivery

Notes
[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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with any SAE from birth to Day 181 post-birth

Top of page

End point title

Percentage of infant subjects with any SAE from birth to Day 181 post-birth ^[41]

End point description

SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[41] - 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	25.4 (15.5 to 37.5)	28.8 (18.8 to 40.6)	30.3 (19.6 to 42.9)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with AE leading to study withdrawal from birth to Day 181 post-birth

Top of page

End point title

Percentage of infant subjects with AE leading to study withdrawal from birth to Day 181 post-birth ^[42]

End point description

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with any MAE from birth to Day 181 post-birth

Top of page

End point title

Percentage of infant subjects with any MAE from birth to Day 181 post-birth ^[43]

End point description

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[43] - 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	40.3 (28.5 to 53)	52.1 (40 to 63.9)	39.4 (27.6 to 52.2)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with any SAE from birth to Month 12 post-birth

Top of page

End point title

Percentage of infant subjects with any SAE from birth to Month 12 post-birth ^[44]

End point description

SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

End point type

Secondary

End point timeframe

From birth to Month 12 post-birth

Notes
[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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	25.4 (15.5 to 37.5)	28.8 (18.8 to 40.6)	31.8 (20.9 to 44.4)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with any AE leading to study withdrawal from birth to Month 12 post-birth

Top of page

End point title

Percentage of infant subjects with any AE leading to study withdrawal from birth to Month 12 post-birth ^[45]

End point description

An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.

End point type

Secondary

End point timeframe

From birth to Month 12 post-birth

Notes
[45] - 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with any MAE from birth to Month 12 post-birth

Top of page

End point title

Percentage of infant subjects with any MAE from birth to Month 12 post-birth ^[46]

End point description

End point type

Secondary

End point timeframe

From birth to Month 12 post-birth

Notes
[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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	43.3 (31.2 to 56)	57.5 (45.4 to 69)	43.9 (31.7 to 56.7)

No statistical analyses for this end point

Secondary: Percentage of maternal subjects with RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)

Top of page

End point title

Percentage of maternal subjects with RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI) ^[47]

End point description

A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.

End point type

Secondary

End point timeframe

From delivery to Day 181 post-delivery

Notes
[47] - 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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	70	75	68
Units: Percentage of maternal subjects
number (confidence interval 95%)	0 (0 to 5.1)	0 (0 to 4.8)	0 (0 to 5.3)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with RSV-associated Lower respiratory tract illness (LRTI)

Top of page

End point title

Percentage of infant subjects with RSV-associated Lower respiratory tract illness (LRTI) ^[48]

End point description

An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (<) 95% or respiratory rate increase and a confirmed RSV infection.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 5.4)	0 (0 to 4.9)	0 (0 to 5.4)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with RSV-associated severe LRTI

Top of page

End point title

Percentage of infant subjects with RSV-associated severe LRTI ^[49]

End point description

A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 93% or lower chest wall in-drawing and a confirmed RSV infection.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[49] - 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 5.4)	0 (0 to 4.9)	0 (0 to 5.4)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with RSV-associated very severe LRTI

Top of page

End point title

Percentage of infant subjects with RSV-associated very severe LRTI ^[50]

End point description

A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[50] - 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 5.4)	0 (0 to 4.9)	0 (0 to 5.4)

No statistical analyses for this end point

Secondary: Percentage of infant subjects with RSV-associated hospitalisation

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End point title

Percentage of infant subjects with RSV-associated hospitalisation ^[51]

End point description

An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.

End point type

Secondary

End point timeframe

From birth to Day 181 post-birth

Notes
[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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	67	73	66
Units: Percentage of infant subjects
number (confidence interval 95%)	0 (0 to 5.4)	0 (0 to 4.9)	0 (0 to 5.4)

No statistical analyses for this end point

Secondary: RSV MAT IgG antibody GMCs in maternal subjects, at day 43 post-delivery

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End point title

RSV MAT IgG antibody GMCs in maternal subjects, at day 43 post-delivery ^[52]

End point description

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.

End point type

Secondary

End point timeframe

At Day 43 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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	53	59	50
Units: EU/mL
geometric mean (confidence interval 95%)	61925 (51966 to 73792)	62871 (53878 to 73364)	8350 (6723 to 10372)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 post-delivery

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End point title

RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 post-delivery ^[53]

End point description

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.

End point type

Secondary

End point timeframe

At Day 43 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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	53	58	50
Units: Titers
geometric mean (confidence interval 95%)	6451.3 (4842.4 to 8594.6)	6290.7 (5000.6 to 7913.7)	943.6 (733.4 to 1213.9)

No statistical analyses for this end point

Secondary: RSV-B neutralizing antibody GMTs in maternal subjects

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End point title

RSV-B neutralizing antibody GMTs in maternal subjects ^[54]

End point description

Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.

End point type

Secondary

End point timeframe

At Day 1 (before vaccination), Day 31, at delivery and Day 43 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 subjects.

End point values	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother
Number of subjects analysed	67	73	68
Units: Titers
geometric mean (confidence interval 95%)
Day 1 (N=67,73,68)	1066.3 (833.7 to 1363.9)	1144.7 (933.1 to 1404.4)	969.5 (790.5 to 1188.9)
Day 31 (N=58,68,58)	13766.2 (10692.6 to 17723.2)	15849.4 (13101 to 19174.4)	1065.8 (846.5 to 1341.8)
Delivery (N=63,66,61)	8983.1 (7079.7 to 11398.1)	13335.6 (10507 to 16925.8)	1190.7 (922.8 to 1536.5)
Day 43 post-delivery (N=53,59,49)	12297.7 (9464.3 to 15979.4)	10027.2 (8033.2 to 12516.2)	1473.8 (1111.1 to 1954.8)

No statistical analyses for this end point

Secondary: RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth

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End point title

RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth ^[55]

End point description

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 43 after birth

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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	13	15	11
Units: EU/mL
geometric mean (confidence interval 95%)	30194.5 (18677.2 to 48813.8)	39378.2 (33586.7 to 46168.4)	2576.1 (1566.4 to 4236.5)

No statistical analyses for this end point

Secondary: RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth

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End point title

RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth ^[56]

End point description

End point type

Secondary

End point timeframe

At Day 121 after birth

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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	17	19	10
Units: EU/mL
geometric mean (confidence interval 95%)	4292.9 (3263 to 5648)	4656.9 (3539.4 to 6127.4)	445.5 (291.4 to 681)

No statistical analyses for this end point

Secondary: RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 181 after birth

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End point title

RSV MAT IgG antibody GMCs in infants born to maternal subjects, at Day 181 after birth ^[57]

End point description

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided samples for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 181 after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	11	19	11
Units: EU/mL
geometric mean (confidence interval 95%)	1224.1 (815.1 to 1838.4)	1433.5 (1116.7 to 1840.1)	179.6 (97.7 to 330.3)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 43 after birth

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End point title

RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 43 after birth ^[58]

End point description

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 43 after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	13	15	11
Units: Titers
geometric mean (confidence interval 95%)	3384.2 (2200.1 to 5205.5)	3509.6 (2525.2 to 4877.6)	613.3 (298.6 to 1259.8)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 121 after birth

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End point title

RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 121 after birth ^[59]

End point description

End point type

Secondary

End point timeframe

At Day 121 after birth

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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	17	19	10
Units: Titers
geometric mean (confidence interval 95%)	762.3 (458.3 to 1268.2)	890.9 (648.5 to 1224)	91.2 (56.8 to 146.5)

No statistical analyses for this end point

Secondary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 181 after birth

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End point title

RSV-A neutralizing antibody GMTs in infants born to maternal subjects, at Day 181 after birth ^[60]

End point description

End point type

Secondary

End point timeframe

At Day 181 after birth

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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	11	20	12
Units: Titers
geometric mean (confidence interval 95%)	278.4 (146 to 530.9)	324.8 (194.6 to 542.3)	47.8 (23.8 to 96)

No statistical analyses for this end point

Secondary: RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at birth

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End point title

RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at birth ^[61]

End point description

Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).

End point type

Secondary

End point timeframe

At delivery or within 3 days after birth

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 infants born to maternal subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	58	64	60
Units: Titers
geometric mean (confidence interval 95%)	13585.6 (10453.9 to 17655.4)	18955 (15694.7 to 22892.6)	1656.8 (1320.3 to 2079)

No statistical analyses for this end point

Secondary: RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 43 after birth

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End point title

RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 43 after birth ^[62]

End point description

Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 43 after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	13	15	11
Units: Titers
geometric mean (confidence interval 95%)	5932.1 (2562.6 to 13731.7)	6905.5 (4373.3 to 10903.8)	548.2 (292.1 to 1028.8)

No statistical analyses for this end point

Secondary: RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 121 after birth

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End point title

RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 121 after birth ^[63]

End point description

Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 121 after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	17	19	10
Units: Titers
geometric mean (confidence interval 95%)	1119 (705.3 to 1775.4)	1367 (950.5 to 1965.9)	141.6 (82 to 244.6)

No statistical analyses for this end point

Secondary: RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 181 after birth

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End point title

RSV-B neutralizing antibody GMTs in infants born to maternal subjects, at Day 181 after birth ^[64]

End point description

Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.

End point type

Secondary

End point timeframe

At Day 181 after 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 subjects.

End point values	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Number of subjects analysed	11	20	12
Units: Titers
geometric mean (confidence interval 95%)	459.8 (245.9 to 859.7)	574 (368.9 to 893.3)	68.8 (27.1 to 174.7)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Maternal groups (Grs.): administration site & systemic AEs collected during 7-day follow-up (FU) after vaccination, unsolicited AEs during 30-day FU after vaccination, SAEs: Day 1- Month 6 post-delivery. Infant Grs. SAEs: Birth-12 months post-birth.

Adverse event reporting additional description

Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

RSV MAT 60 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 120 Group-Mother

Reporting group description

Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.

Reporting group title

Control Group-Mother

Reporting group description

Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.

Reporting group title

RSV MAT 60 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSVMAT60Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.

Reporting group title

RSV MAT 120 Group-Infant

Reporting group description

This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.

Reporting group title

Control Group-Infant

Reporting group description

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

Serious adverse events	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Total subjects affected by serious adverse events
subjects affected / exposed	16 / 70 (22.86%)	21 / 75 (28.00%)	15 / 68 (22.06%)	17 / 67 (25.37%)	21 / 73 (28.77%)	21 / 66 (31.82%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infantile haemangioma
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
subjects affected / exposed	2 / 70 (2.86%)	9 / 75 (12.00%)	6 / 68 (8.82%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 9	0 / 6	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	3 / 70 (4.29%)	2 / 75 (2.67%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged labour
subjects affected / exposed	0 / 70 (0.00%)	2 / 75 (2.67%)	3 / 68 (4.41%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foetal growth restriction
subjects affected / exposed	1 / 70 (1.43%)	3 / 75 (4.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oligohydramnios
subjects affected / exposed	2 / 70 (2.86%)	1 / 75 (1.33%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	2 / 70 (2.86%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature labour
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	2 / 68 (2.94%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstructed labour
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature delivery
subjects affected / exposed	0 / 70 (0.00%)	2 / 75 (2.67%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Preterm premature rupture of membranes
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arrested labour
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breech presentation
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foetal cardiac disorder
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prolonged rupture of membranes
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stillbirth
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Umbilical cord compression
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Premature baby
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	3 / 73 (4.11%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice neonatal
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	1 / 73 (1.37%)	2 / 66 (3.03%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Low birth weight baby
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Cyst
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	2 / 67 (2.99%)	2 / 73 (2.74%)	4 / 66 (6.06%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meconium aspiration syndrome
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Choking
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal aspiration
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory depression
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory distress syndrome
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal respiratory failure
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Cardiac murmur
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital naevus
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	4 / 67 (5.97%)	3 / 73 (4.11%)	4 / 66 (6.06%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 4	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ankyloglossia congenital
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	2 / 73 (2.74%)	3 / 66 (4.55%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cryptorchism
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypospadias
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	2 / 73 (2.74%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Birth mark
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital acrochordon
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital arterial malformation
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital foot malformation
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital pneumonia
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital skin dimples
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital viral hepatitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hooded prepuce
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Naevus flammeus
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Patent ductus arteriosus
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Phimosis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Polydactyly
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Preauricular cyst
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Supernumerary nipple
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular septal defect
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiomegaly
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Bell's palsy
subjects affected / exposed	1 / 70 (1.43%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia neonatal
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Dacryostenosis acquired
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Umbilical hernia
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	1 / 67 (1.49%)	2 / 73 (2.74%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meconium ileus
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholestasis of pregnancy
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia neonatal
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal cholestasis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Macule
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	2 / 67 (2.99%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin discolouration
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Pelvi-ureteric obstruction
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Amniotic cavity infection
subjects affected / exposed	1 / 70 (1.43%)	2 / 75 (2.67%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mastitis
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neonatal pneumonia
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis neonatal
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	1 / 73 (1.37%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	RSV MAT 60 Group-Mother	RSV MAT 120 Group-Mother	Control Group-Mother	RSV MAT 60 Group-Infant	RSV MAT 120 Group-Infant	Control Group-Infant
Total subjects affected by non serious adverse events
subjects affected / exposed	56 / 70 (80.00%)	66 / 75 (88.00%)	47 / 68 (69.12%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	1	0	0	0
Uterine contractions during pregnancy
subjects affected / exposed	0 / 70 (0.00%)	2 / 75 (2.67%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	2	0	0	0	0
Gestational diabetes
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	40 / 70 (57.14%)	39 / 75 (52.00%)	10 / 68 (14.71%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	40	39	10	0	0	0
Fatigue
subjects affected / exposed	28 / 70 (40.00%)	26 / 75 (34.67%)	17 / 68 (25.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	28	28	17	0	0	0
Injection site erythema
subjects affected / exposed	1 / 70 (1.43%)	5 / 75 (6.67%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	5	0	0	0	0
Injection site swelling
subjects affected / exposed	3 / 70 (4.29%)	3 / 75 (4.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	3	3	0	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 70 (2.86%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	0	1	0	0	0
Influenza like illness
subjects affected / exposed	1 / 70 (1.43%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	1	0	0	0	0
Asthenia
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Feeling hot
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Induration
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Injection site irritation
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Malaise
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Swelling
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Reproductive system and breast disorders
Vaginal haemorrhage
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Vulvovaginal discomfort
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	1 / 70 (1.43%)	3 / 75 (4.00%)	2 / 68 (2.94%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	3	2	0	0	0
Cough
subjects affected / exposed	1 / 70 (1.43%)	1 / 75 (1.33%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	1	1	0	0	0
Nasal congestion
subjects affected / exposed	1 / 70 (1.43%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	1	0	0	0	0
Asthma
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Asthmatic crisis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Respiratory disorder
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Sinus congestion
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	2	0	0	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	1	0	0	0
Depression
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	25 / 70 (35.71%)	21 / 75 (28.00%)	14 / 68 (20.59%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	25	23	14	0	0	0
Dizziness
subjects affected / exposed	2 / 70 (2.86%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	0	1	0	0	0
Migraine
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Blood and lymphatic system disorders
Anaemia of pregnancy
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Eye disorders
Vision blurred
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Gastrointestinal disorders
Nausea
subjects affected / exposed	18 / 70 (25.71%)	17 / 75 (22.67%)	9 / 68 (13.24%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	18	17	9	0	0	0
Abdominal pain
subjects affected / exposed	9 / 70 (12.86%)	17 / 75 (22.67%)	7 / 68 (10.29%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	9	18	9	0	0	0
Diarrhoea
subjects affected / exposed	11 / 70 (15.71%)	13 / 75 (17.33%)	9 / 68 (13.24%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	11	13	9	0	0	0
Vomiting
subjects affected / exposed	5 / 70 (7.14%)	7 / 75 (9.33%)	4 / 68 (5.88%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	5	7	4	0	0	0
Abdominal discomfort
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	1	0	0	0
Abdominal pain lower
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Constipation
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Gastrointestinal disorder
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Mouth cyst
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Teething
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Toothache
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Hepatobiliary disorders
Cholestasis of pregnancy
subjects affected / exposed	1 / 70 (1.43%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	1	0	0	0	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Renal and urinary disorders
Glycosuria
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Nephrolithiasis
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 70 (1.43%)	3 / 75 (4.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	3	0	0	0	0
Pain in extremity
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	1	0	0	0
Arthralgia
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Groin pain
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Ligament pain
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	4 / 68 (5.88%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	4	0	0	0
Urinary tract infection
subjects affected / exposed	2 / 70 (2.86%)	1 / 75 (1.33%)	2 / 68 (2.94%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	1	2	0	0	0
Influenza
subjects affected / exposed	0 / 70 (0.00%)	3 / 75 (4.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	3	1	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 70 (0.00%)	2 / 75 (2.67%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	2	1	0	0	0
Acute sinusitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Asymptomatic bacteriuria
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Beta haemolytic streptococcal infection
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Fungal infection
subjects affected / exposed	0 / 70 (0.00%)	0 / 75 (0.00%)	1 / 68 (1.47%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	0	1	0	0	0
Hordeolum
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Respiratory tract infection
subjects affected / exposed	1 / 70 (1.43%)	0 / 75 (0.00%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	1	0	0	0	0	0
Tooth abscess
subjects affected / exposed	0 / 70 (0.00%)	1 / 75 (1.33%)	0 / 68 (0.00%)	0 / 67 (0.00%)	0 / 73 (0.00%)	0 / 66 (0.00%)
occurrences all number	0	1	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

27 Jan 2020

1. To increase enrolment from 150 to 300 maternal subjects, thereby providing additional safety and immune response data in support of subsequent studies. 2. To better facilitate protocol implementation and analysis by correcting the end of study definition and clarifying the language used to describe: several inclusion and exclusion criteria, the NaCl formulation, and several study procedures. 3. Other administrative changes have been made, and typographical errors have been corrected.

11 May 2020

To provide measures that may be applicable during special circumstances (e.g., COVID-19 pandemic). The purpose of the amendment is to protect participant’s welfare and safety, and as far as possible ensure the potential benefit to the participant and promote data integrity.

30 Sep 2020

This protocol is amended to reflect the possibility of inadvertent unblinding of investigators and site staff to some subjects’ treatment assignments in the context of Investigator’s Brochure (IB) safety data updates following analysis 2. After the second analysis, the study will not be considered observer blind as the investigator brochure will be updated to include safety information presented by treatment group. In addition, this amendment outlines a plan to implement additional contacts for safety monitoring in the event of problems with electronic diary data capture.

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

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of maternal subjects with any solicited administration site events

Primary: Percentage of maternal subjects with any solicited administration site events

Primary: Percentage of maternal subjects with any solicited systemic events

Primary: Percentage of maternal subjects with any solicited systemic events

Primary: Number of maternal subjects with any haematological laboratory abnormalities at Day 8 by baseline ranges

Primary: Number of maternal subjects with any haematological laboratory abnormalities at Day 8 by baseline ranges

Primary: Number of maternal subjects with any biochemical laboratory abnormalities at Day 8 by baseline ranges

Primary: Number of maternal subjects with any biochemical laboratory abnormalities at Day 8 by baseline ranges

Primary: Percentage of maternal subjects with any unsolicited adverse events (AEs)

Primary: Percentage of maternal subjects with any unsolicited adverse events (AEs)

Primary: Percentage of maternal subjects with any serious adverse events (SAEs)

Primary: Percentage of maternal subjects with any serious adverse events (SAEs)

Primary: Percentage of maternal subjects with AEs leading to study withdrawal

Primary: Percentage of maternal subjects with AEs leading to study withdrawal

Primary: Percentage of maternal subjects with any medically attended AEs (MAE)

Primary: Percentage of maternal subjects with any medically attended AEs (MAE)

Primary: Percentage of maternal subjects with pregnancy outcomes

Primary: Percentage of maternal subjects with pregnancy outcomes

Primary: Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs)

Primary: Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs)

Primary: Percentage of infant subjects with neonatal AESIs

Primary: Percentage of infant subjects with neonatal AESIs

Primary: Percentage of infant subjects with any SAEs

Primary: Percentage of infant subjects with any SAEs

Primary: Percentage of infant subjects with AEs leading to study withdrawal

Primary: Percentage of infant subjects with AEs leading to study withdrawal

Primary: Percentage of infant subjects with any MAEs

Primary: Percentage of infant subjects with any MAEs

Primary: RSV MAT Immunoglobulin G (IgG)-specific antibody concentrations in terms of Geometric Mean Concentrations (GMCs) in maternal subjects

Primary: RSV MAT Immunoglobulin G (IgG)-specific antibody concentrations in terms of Geometric Mean Concentrations (GMCs) in maternal subjects

Primary: RSV-A neutralizing antibody Geometric Mean Titers (GMTs) in maternal subjects

Primary: RSV-A neutralizing antibody Geometric Mean Titers (GMTs) in maternal subjects

Primary: RSV MAT IgG antibody GMCs in infants born to maternal subjects

Primary: RSV MAT IgG antibody GMCs in infants born to maternal subjects

Primary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects

Primary: RSV-A neutralizing antibody GMTs in infants born to maternal subjects

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

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

Secondary: Percentage of maternal subjects with any SAE from Day 1 to Day 181 post delivery

Secondary: Percentage of maternal subjects with any SAE from Day 1 to Day 181 post delivery

Secondary: Percentage of maternal subjects with any MAE from Day 1 to Day 181 post delivery

Secondary: Percentage of maternal subjects with any MAE from Day 1 to Day 181 post delivery

Secondary: Percentage of maternal subjects with AE leading to study withdrawal from Day 1 to Day 181 post delivery

Secondary: Percentage of maternal subjects with AE leading to study withdrawal from Day 1 to Day 181 post delivery

Secondary: Percentage of infant subjects with any SAE from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with any SAE from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with AE leading to study withdrawal from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with AE leading to study withdrawal from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with any MAE from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with any MAE from birth to Day 181 post-birth

Secondary: Percentage of infant subjects with any SAE from birth to Month 12 post-birth

Secondary: Percentage of infant subjects with any SAE from birth to Month 12 post-birth

Secondary: Percentage of infant subjects with any AE leading to study withdrawal from birth to Month 12 post-birth

Secondary: Percentage of infant subjects with any AE leading to study withdrawal from birth to Month 12 post-birth

Secondary: Percentage of infant subjects with any MAE from birth to Month 12 post-birth

Secondary: Percentage of infant subjects with any MAE from birth to Month 12 post-birth

Secondary: Percentage of maternal subjects with RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)

Secondary: Percentage of maternal subjects with RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)

Secondary: Percentage of infant subjects with RSV-associated Lower respiratory tract illness (LRTI)

Secondary: Percentage of infant subjects with RSV-associated Lower respiratory tract illness (LRTI)

Secondary: Percentage of infant subjects with RSV-associated severe LRTI

Secondary: Percentage of infant subjects with RSV-associated severe LRTI

Secondary: Percentage of infant subjects with RSV-associated very severe LRTI

Secondary: Percentage of infant subjects with RSV-associated very severe LRTI

Secondary: Percentage of infant subjects with RSV-associated hospitalisation

Secondary: Percentage of infant subjects with RSV-associated hospitalisation

Secondary: RSV MAT IgG antibody GMCs in maternal subjects, at day 43 post-delivery

Secondary: RSV MAT IgG antibody GMCs in maternal subjects, at day 43 post-delivery

Secondary: RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 post-delivery

Secondary: RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 post-delivery

Secondary: RSV-B neutralizing antibody GMTs in maternal subjects