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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery. |
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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 within 2 years 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 within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to day 42 post-delivery.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Retrospective cohort Adult/Adolescent Participant: • Adult/Adolescent study participant, from any of the prior RSV MAT 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 any of the prior RSV MAT 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. |
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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 and does not plan to use any additional measures to attempt to conceive a pregnancy (e.g., sterilization reversal or IVF). Infant participant: • Child in care |
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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 within 2 years 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 within 2 years post-vaccination 3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination |
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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 within 2 years post-vaccination 2. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 3. From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination |
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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 within 2 years post-vaccination 2. Percentage of maternal participants reporting pregnancy related AESIs from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination 3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years 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 within 2 years 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 within 2 years 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 within 2 years 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 within 2 years 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 within 2 years 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 within 2 years post-vaccination |
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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 within 2 years post-vaccination 3, 6. From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination 7, 8. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 9. From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination |
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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 | Yes |
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 | 57 |
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 |
Bangladesh |
Colombia |
Dominican Republic |
Honduras |
New Zealand |
Panama |
Philippines |
Taiwan |
Australia |
Belgium |
Brazil |
Canada |
Finland |
France |
Germany |
India |
Italy |
Korea, Republic of |
Mexico |
South Africa |
Spain |
Thailand |
United States |
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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
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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 or who are pregnant at enrollment The study may be terminated earlier if other research demonstrates no impact of vaccination on pregnancies conceived post vaccination. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 29 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 29 |