Clinical Trial Page

Summary
EudraCT Number:2022-003124-41
Sponsor's Protocol Code Number:219510
National Competent Authority:Finland - Fimea
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-01-03
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedFinland - Fimea
A.2EudraCT number2022-003124-41
A.3Full title of the trial
A non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) during any pregnancy conceived post vaccination/control.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A follow-up study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV MAT studies during any pregnancy conceived post vaccination/control.
A.3.2Name or abbreviated title of the trial where available
RSV MAT-015
A.4.1Sponsor's protocol code number219510
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorGlaxoSmithKline Biologicals SA
B.1.3.4CountryBelgium
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals SA
B.4.2CountryBelgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationGlaxoSmithKline Biologicals SA
B.5.2Functional name of contact pointClinical Disclosure Advisor
B.5.3 Address:
B.5.3.1Street AddressRue de l'Institut, 89
B.5.3.2Town/ city1330 Rixensart
B.5.3.3Post code1330 44 20 899
B.5.3.4CountryBelgium
B.5.4Telephone number44 20 89904466
B.5.6E-mailGSKClinicalSupportHD@gsk.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRSV MAT
D.3.2Product code GSK3888550A
D.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameGSKVx000000017076
D.3.9.4EV Substance CodeSUB201132
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRSV MAT
D.3.2Product code GSK3888550A
D.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameGSKVx000000017076
D.3.9.4EV Substance CodeSUB201132
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number60
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRSV MAT
D.3.2Product code GSK3888550A
D.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameGSKVx000000017076
D.3.9.4EV Substance CodeSUB201132
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number120
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 4
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Influsplit Tetra/Fluarix Tetra
D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameA/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215)
D.3.9.4EV Substance CodeSUB223932
D.3.10 Strength
D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameInfluenza A virus, A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, IVR-221), Inactivated
D.3.10 Strength
D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameB/Washington/02/2019 - like virus (B/Washington/02/2019, wild type)
D.3.10 Strength
D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.3Other descriptive nameB/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE)
D.3.9.4EV Substance CodeSUB178474
D.3.10 Strength
D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 5
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Boostrix
D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBoostrix
D.3.2Product code dTpa
D.3.4Pharmaceutical form Suspension for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.2Current sponsor codeD
D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
D.3.9.4EV Substance CodeSUB12489MIG
D.3.10 Strength
D.3.10.1Concentration unit IU international unit(s)
D.3.10.2Concentration typenot less then
D.3.10.3Concentration number2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.2Current sponsor codeT
D.3.9.3Other descriptive nameTETANUS TOXOID
D.3.9.4EV Substance CodeSUB12608MIG
D.3.10 Strength
D.3.10.1Concentration unit IU international unit(s)
D.3.10.2Concentration typenot less then
D.3.10.3Concentration number20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.2Current sponsor codePT
D.3.9.3Other descriptive namePERTUSSIS TOXOID
D.3.9.4EV Substance CodeSUB14817MIG
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.2Current sponsor codeFHA
D.3.9.3Other descriptive nameFILAMENTOUS HAEMAGGLUTININ
D.3.9.4EV Substance CodeSUB38509
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNA
D.3.9.2Current sponsor codePRN
D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
D.3.9.4EV Substance CodeSUB20527
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number2.5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution for injection
D.8.4Route of administration of the placeboIntramuscular use
D.8 Placebo: 2
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboPowder and solvent for solution for injection
D.8.4Route of administration of the placeboIntramuscular use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants
E.1.1.1Medical condition in easily understood language
Pregnancy related outcomes and events in mothers after vaccination against RSV or administration of control, and in their infants
E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10070538
E.1.2Term Gestational hypertension
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10036485
E.1.2Term Pre-eclampsia
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 25.0
E.1.2Level LLT
E.1.2Classification code 10086971
E.1.2Term Pre-eclampsia with severe features
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10070532
E.1.2Term Fetal growth restriction
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10073024
E.1.2Term Preterm premature rupture of membranes
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10075863
E.1.2Term Preterm labor
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10018210
E.1.2Term Gestational diabetes mellitus
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008755
E.1.2Term Chorioamnionitis
E.1.2System Organ Class 100000004862
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10041093
E.1.2Term Small for gestational age
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level PT
E.1.2Classification code 10067508
E.1.2Term Low birth weight baby
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10067509
E.1.2Term Very low birth weight baby
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level LLT
E.1.2Classification code 10074164
E.1.2Term Extremely low birth weight baby
E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level PT
E.1.2Classification code 10011912
E.1.2Term Death neonatal
E.1.2System Organ Class 10018065 - General disorders and administration site conditions
E.1.2 Medical condition or disease under investigation
E.1.2Version 25.0
E.1.2Level PT
E.1.2Classification code 10086969
E.1.2Term Medically induced preterm birth
E.1.2System Organ Class 10042613 - Surgical and medical procedures
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To describe the incidence of pregnancy outcomes, pregnancy related adverse events of special interest (AESIs) and infant AESIs during the first pregnancy conceived post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery.
E.2.2Secondary objectives of the trial
• To describe the incidence of pregnancy outcomes, pregnancy related AESIs and infant AESIs during any pregnancy conceived post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery.
• To describe the incidence of selected pregnancy outcomes, pregnancy related AESIs and infant AESIs by risk status and by selected risk factors for or causes of those events/outcomes during pregnancies conceived post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to day 42 post-delivery.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Retrospective cohort
Adult/Adolescent Participant:
• Adult/Adolescent study participant, from RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 or RSV MAT-039 studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
• Study participant:
-who has reached 2 years+2 months post vaccine/control prior to/at enrolment or
-who has not reached 2 years+2 months post vaccine/control prior to/at enrolment but is a Woman of Nonchildbearing Potential (WONCBP) at study enrolment, or recipient of bilateral tubal ligation prior to study enrolment.
• Study participant with any pregnancy conceived post vaccination/control, that has reached Day 42 post-delivery prior to/at enrollment.
• Provide signed and dated informed consent form.
• Be willing to comply with all study requirements and be available for the duration of the study.
Infant Participant:
• Participant live born as the result of a pregnancy followed in an adult/adolescent participant in this study.
• Signed and dated informed consent form obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.

Prospective cohort
Adult/Adolescent Participant:
• Adult/adolescent study participant from RSV-MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 or RSV MAT-039 studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
• Study participant:
-who has not reached 2 years+2 months post vaccine/control prior to/at enrollment or
-who has reached at least 2 years+2 months post vaccine/control but has an ongoing pregnancy (prior to Day 42 post-delivery) at enrollment. Participants who have reached 2 years post-vaccine/control before enrollment but are pregnant at enrollment will be enrolled and followed until Day 42 post-delivery for the pregnancy ongoing at enrollment.
• Female participants of childbearing potential
• Provide signed and dated informed consent form.
• Be willing to comply with all study procedures and be available for the duration of the study.
Infant Participant:
• Participant live born as the result of a pregnancy followed in an adolescent/adult participant in this study
• Participant’s parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol
• Signed and dated informed consent form obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
E.4Principal exclusion criteria
Adult/adolescent participant otherwise eligible for the prospective cohort:
• Woman of Nonchildbearing Potential (WONCBP) at study enrollment, or recipient of bilateral tubal ligation prior to study enrollment, if she has not conceived a pregnancy post-vaccine/control.
Infant participant:
• Child in care
E.5 End points
E.5.1Primary end point(s)
1. Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
2. Percentage of maternal participants reporting pregnancy related adverse events of special interest (AESIs) from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination
E.5.1.1Timepoint(s) of evaluation of this end point
1. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
2. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
3. From birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination
E.5.2Secondary end point(s)
1. Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination
2. Percentage of maternal participants reporting pregnancy related AESIs from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination
3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived post-vaccination
4. Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination
5. Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination
6. Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of any pregnancy conceived post-vaccination
7. Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
8. Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
9. Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination
E.5.2.1Timepoint(s) of evaluation of this end point
1, 2, 4, 5. From Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination
3, 6. From birth up to Day 42 post-birth of any pregnancy conceived post-vaccination
7, 8. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination
9. From birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised No
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned14
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA62
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Argentina
Australia
Bangladesh
Brazil
Canada
Colombia
Dominican Republic
Honduras
India
Korea, Republic of
Mexico
New Zealand
Panama
Philippines
South Africa
Taiwan
Thailand
United States
Finland
France
Spain
Germany
Italy
Belgium
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
The study period ends at:
- current study enrollment for retrospective cohort participants
- 2 years+2 months post vaccine/control for prospective cohort participants who are not pregnant at 2 years post vaccine/control
- Day 42 post-delivery for prospective cohort participants who are pregnant at 2 years post vaccine/control
The study may be terminated earlier if other research demonstrates no impact of vaccination on pregnancies conceived post vaccination.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months1
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months1
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 20
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 1
F.1.1.6Adolescents (12-17 years) Yes
F.1.1.6.1Number of subjects for this age range: 19
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 8220
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients No
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-01-03. Yes
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women Yes
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state135
F.4.2 For a multinational trial
F.4.2.1In the EEA 1640
F.4.2.2In the whole clinical trial 5343
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-03-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-01-24
P. End of Trial
P.End of Trial StatusOngoing

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