Clinical trial NCT05705440: 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
Official title: A Phase 3b, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Pregnancy
RSVPreF3 vaccine
Safety
Follow-up study
Retrospective data
Prospective data
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 3962
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this follow-up study is to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.

The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905).

No intervention will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
Secondary outcomes:
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
measure: Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
timeFrame: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
measure: 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
timeFrame: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
Other outcomes:
Locations:
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state: Alabama
city: Phoenix
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state: Arizona
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
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country: Finland
facility: GSK Investigational Site
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country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
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facility: GSK Investigational Site
city: Bordeaux
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city: Bron
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country: India
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city: Mangalore
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city: Mysore
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city: Nagpur
country: India
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country: India
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city: Bari
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city: Messina
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city: Prato
country: Italy
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country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Grafton Auckland
country: New Zealand
facility: GSK Investigational Site
city: Papatoetoe Auckland
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Ciudad de Panama
country: Panama
facility: GSK Investigational Site
city: Panama
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city: Panama
country: Panama
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city: Panama
country: Panama
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city: Panama
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city: Manila
country: Philippines
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city: Manila
country: Philippines
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city: Johannesburg
country: South Africa
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city: Burgos
country: Spain
facility: GSK Investigational Site
city: Getafe
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
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city: Marbella
country: Spain
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country: Spain
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city: Sevilla
country: Spain
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country: Spain
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country: Spain
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city: Valencia
country: Spain
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country: Spain
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city: Valencia
country: Spain
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city: Valladolid
country: Spain
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country: Taiwan
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city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: ChiangMai
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: