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

NCT05705440 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2195102022-003124-41
• Study Type: interventional
• Target: 3,855
• Locations: 23 countries
• Sites: 138

Brief Summary

The purpose of this follow-up study was 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 was administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the abovementioned prior RSV MAT studies.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Pregnancy; RSVPreF3 vaccine; Safety; Follow-up study; Retrospective data; Prospective data

Outcome Measures

Primary Outcomes (3)

• Number of Maternal Participants With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  Assessed pregnancy outcomes were live infant with no apparent congenital anomaly; spontaneous abortion with no apparent congenital anomaly; ectopic pregnancy; elective termination with no apparent congenital anomaly; live infant with congenital anomaly, and stillbirth with congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.

  From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  Assessed pregnancy-related AESIs were chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, premature preterm ruptures of membranes, preterm labor and provider-initiated preterm birth. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.

  From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  Assessed AESIs were congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, low birth weight \[greater than or equal to (\>=) 1500 grams (G) and below (\<) 2500 G\], very low birth weight (\>=1000 G and \<1500 G), neonatal death in a term live birth (\>=37 weeks of gestational age), preterm birth (\<37 weeks of gestational age) and small for gestational age.

  From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

Secondary Outcomes (17)

• Number of Pregnancies With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Pregnancies With Pregnancy-related AESIs From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of Any Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  From birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Pregnancies With Preterm Birth Event Data Stratified by Selected Risk Factors, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

• Number of Pregnancies With Preterm Birth Event Data Stratified by Age Group at Vaccination, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies

  From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

Study Arms (4)

RSV MAT Group - Mother

OTHER

Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

Biological: RSVPreF3 vaccine

Control Group - Mother

OTHER

Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

Other: Control

RSV MAT Group - Infant

NO INTERVENTION

This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.

Control Group - Infant

NO INTERVENTION

This group consisted of infants live-born to maternal participants in the Control Group - Mother.

Interventions

RSVPreF3 vaccine BIOLOGICAL

No intervention was administered in this extension study. Participants received the RSVPreF3 vaccine during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.

RSV MAT Group - Mother

Control OTHER

No intervention was administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).

Control Group - Mother

Eligibility Criteria

• Age: 9 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (138)

GSK Investigational Site

Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85015, United States

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Tucson, Arizona, 85712, United States

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Burbank, California, 91506, United States

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Los Angeles, California, 90057, United States

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Nampa, Idaho, 83686, United States

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Nampa, Idaho, 83702, United States

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Covington, Louisiana, 70433, United States

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Slidell, Louisiana, 70458, United States

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Detroit, Michigan, 48201, United States

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Saginaw, Michigan, 48604, United States

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Biloxi, Mississippi, 39531, United States

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Albuquerque, New Mexico, 87107, United States

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Englewood, Ohio, 45322, United States

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Greenville, South Carolina, 29607, United States

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Hendersonville, Tennessee, 29708, United States

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Austin, Texas, 78705, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77008, United States

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Keller, Texas, 76012, United States

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Keller, Texas, 76028, United States

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Keller, Texas, 76051, United States

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Lampasas, Texas, 76550, United States

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Plano, Texas, 75093, United States

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Weatherford, Texas, 76086, United States

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Norfolk, Virginia, 68701, United States

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Seattle, Washington, 98104, United States

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Buenos Aires, 1425, Argentina

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Córdoba, 5800, Argentina

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South Brisbane, Queensland, 4101, Australia

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Southport, Queensland, 4215, Australia

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Clayton, Victoria, 3168, Australia

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Matlab, Bangladesh

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Sylhet, 3100, Bangladesh

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Sint-Niklaas, 9100, Belgium

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Nova Iguaçu, 26030-380, Brazil

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Porto Alegre, 90035001, Brazil

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RibeirAo PretoSP, 14051-140, Brazil

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Santa Maria, 97105-900, Brazil

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São José do Rio Preto, 15090-000, Brazil

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Surrey, British Columbia, V3S 2N6, Canada

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Vancouver, British Columbia, V6Z 2T1, Canada

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Halifax, Nova Scotia, B3K 6R8, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London-Ontario, Ontario, N5W 6A2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Joliette, Quebec, J6E 6A9, Canada

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Montreal, Quebec, H3T 1C5, Canada

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Montreal, Quebec, H9R 4S3, Canada

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Montreal, Quebec, J7J 2K8, Canada

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Québec, Quebec, G1V 4G2, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1L 0H8, Canada

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Barranquilla, 760002, Colombia

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Cali Colombia, 760042, Colombia

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Chía, 250001, Colombia

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Medellín, 050034, Colombia

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Santo Domingo Este, Dominican Republic

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Espoo, 02230, Finland

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Helsinki, 00100, Finland

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Helsinki, 00290, Finland

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Helsinki, 00930, Finland

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Jarvenpaa, 04400, Finland

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Kokkola, 67100, Finland

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Oulu, 90220, Finland

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Pori, 28100, Finland

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Seinäjoki, 60100, Finland

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Tampere, 33100, Finland

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Turku, 20520, Finland

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Bordeaux, 33000, France

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Bron, 69500, France

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Paris, 75679, France

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Goch, 47574, Germany

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Hamburg, 22143, Germany

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Hanover, 30159, Germany

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Mainz, 55116, Germany

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Würzburg, 97070, Germany

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Comayagua, Honduras

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San Pedro Sula, 21101, Honduras

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Kolkata, 700017, India

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Mangalore, 575001, India

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Mysore, 570015, India

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Nagpur, 441108, India

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Pune, 411043, India

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Vadu Budruk Pune, 412216, India

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Bari, 70124, Italy

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Messina, 98124, Italy

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Milan, 20154, Italy

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Prato, 59100, Italy

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Grafton Auckland, 1010, New Zealand

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Papatoetoe Auckland, 1701, New Zealand

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Wellington, 6002, New Zealand

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Panama City, 07079, Panama

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Panama City, 0801, Panama

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Panama City, 1001, Panama

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Panama City, 7099, Panama

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Manila, 1000, Philippines

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Manila, 1008, Philippines

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Johannesburg, 2112, South Africa

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Pretoria, 0184, South Africa

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Soshanguve, 0152, South Africa

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Soweto Gauteng, 2013, South Africa

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Ansan, 425-707, South Korea

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Seoul, 08308, South Korea

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Seoul, South Korea

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Aravaca, 28023, Spain

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Barcelona, 08035, Spain

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Bilbao, 48013, Spain

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Boadilla Del Monte Madrid, 28660, Spain

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Burgos, 09006, Spain

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Getafe, 28905, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Madrid, 28222, Spain

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Madrid, 28400, Spain

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Marbella, 29603, Spain

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Málaga, 29004, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41013, Spain

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Seville, 41014, Spain

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TorrejOn Ardoz Madrid, 28850, Spain

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Valencia, 46017, Spain

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Valencia, 46020, Spain

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Valencia, 46702, Spain

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Valladolid, 47012, Spain

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Taichung, 40447, Taiwan

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Taipei, 0105, Taiwan

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Taipei, 10041, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10330, Thailand

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Chiang Mai, 50200, Thailand

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MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: February 7, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ZA (4); US (27); AR (2); DO (1); AU (3); NZ (3); PH (2); CA (15); PA (4); IN (6); DE (5); TW (4); CO (4); BE (3); FI (11); TH (2); HO (2); KR (3); ES (23); IT (4); BA (2); FR (3); BR (5)