E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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.1.1.1 | Medical 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.1.1.2 | Therapeutic 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.1.2 | Version | 20.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10070538 | E.1.2 | Term | Gestational hypertension | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10036485 | E.1.2 | Term | Pre-eclampsia | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 25.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10086971 | E.1.2 | Term | Pre-eclampsia with severe features | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10070532 | E.1.2 | Term | Fetal growth restriction | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10073024 | E.1.2 | Term | Preterm premature rupture of membranes | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10075863 | E.1.2 | Term | Preterm labor | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10018210 | E.1.2 | Term | Gestational diabetes mellitus | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008755 | E.1.2 | Term | Chorioamnionitis | E.1.2 | System Organ Class | 100000004862 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10041093 | E.1.2 | Term | Small for gestational age | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10067508 | E.1.2 | Term | Low birth weight baby | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10067509 | E.1.2 | Term | Very low birth weight baby | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10074164 | E.1.2 | Term | Extremely low birth weight baby | E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10011912 | E.1.2 | Term | Death neonatal | E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 25.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10086969 | E.1.2 | Term | Medically induced preterm birth | E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary 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.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If 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.8.7 | Trial 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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |