RSVPreF3 Vaccine Safety in Subsequent Pregnancies

Recruiting at 155 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Disqualifiers: Nonchildbearing potential, Child in care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

3962 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the study team for guidance.

What data supports the idea that RSVPreF3 Vaccine Safety in Subsequent Pregnancies is an effective treatment?

The available research shows that the RSVPreF3 vaccine is safe and effective in increasing immune responses against respiratory syncytial virus (RSV) in both mothers and their infants. In a study, pregnant women who received the vaccine had no adverse effects on pregnancy or the development of their babies. The vaccine helped protect infants by passing on antibodies from the mother, which are proteins that help fight infections. This suggests that the RSVPreF3 vaccine is a promising treatment for preventing RSV in newborns. ^{1 2 3 4 5}

What safety data exists for the RSVPreF3 vaccine in subsequent pregnancies?

The provided research does not contain specific safety data for the RSVPreF3 vaccine or its variants like RSVPreF3-Mat. The studies focus on the safety of influenza and Tdap vaccines during pregnancy, demonstrating their safety and lack of association with adverse outcomes. However, these findings do not directly apply to the RSVPreF3 vaccine. Further research specific to RSVPreF3 is needed to determine its safety in subsequent pregnancies. ^{6 7 8 9 10}

Is the RSVPreF3 vaccine a promising treatment for use in subsequent pregnancies?

Yes, the RSVPreF3 vaccine is a promising treatment. It has shown to be safe and effective in boosting the immune response against respiratory syncytial virus (RSV) in mothers and their infants. This vaccine helps protect infants by transferring protective antibodies from the mother during pregnancy, which can help prevent RSV-related illnesses in newborns. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This study is for adults who previously participated in certain RSV vaccine trials and either became pregnant after receiving the RSVPreF3 vaccine or a control. It includes those currently pregnant or who have given birth, as well as infants born from these pregnancies. Participants must consent to follow-up and be able to comply with study requirements.

Inclusion Criteria

Study participant with any pregnancy conceived post vaccination/control that has reached Day 42 post-delivery prior to/at enrollment

Be willing to comply with all study requirements and be available for the duration of the study

Study participant who has reached 2 years+2 months post vaccine/control prior to/at enrollment or is a Woman of Nonchildbearing Potential (WONCBP) at study enrollment or recipient of bilateral tubal ligation prior to study enrollment

Exclusion Criteria

I cannot become pregnant, either naturally or through medical procedures.

My child is in the care system and is participating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Follow-up

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.

Long-term

Data Analysis

Data collected from follow-up visits are analyzed to assess safety outcomes.

4-8 weeks

Treatment Details

Interventions

• Control
• RSVPreF3 vaccine

Trial Overview No new interventions are being tested. This follow-up study aims to monitor the safety of participants (and their infants) from previous RSV MAT studies where they received either an experimental RSV vaccine or a control during pregnancy.

Participant Groups

Group I: RSVPreF3 Group Experimental Treatment 1 Intervention

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

Group II: Control Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

The study involving 48 young adults and 1005 older adults demonstrated that the RSVPreF3 vaccine significantly boosted immune responses, particularly after the first dose, with higher levels of RSV-specific antibodies and T cells observed in participants receiving the AS01-adjuvanted formulation.

Safety assessments revealed that most side effects were mild to moderate and temporary, with no significant safety concerns identified, leading to the selection of the AS01E-adjuvanted vaccine for further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. Leroux-Roels, I., Davis, MG., Steenackers, K., et al.[2023]

The RSVPreF3 vaccine candidate from GSK is designed to protect both young children and older adults against respiratory syncytial virus (RSV), with different vaccination strategies for each age group.

In toxicity studies involving rabbits and rats, the RSVPreF3 vaccine was found to be well-tolerated, showing only mild inflammatory reactions and no adverse effects on female fertility or the development of offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated Dose Toxicity Study and Developmental and Reproductive Toxicology Studies of a Respiratory Syncytial Virus Candidate Vaccine in Rabbits and Rats. Stokes, AH., Franklin, K., Fisher, DE., et al.[2022]

The RSV PFP-2 vaccine was found to be safe and well tolerated in 35 pregnant women, with no serious adverse events reported, and only mild injection site pain experienced by some participants.

The vaccine elicited a strong immune response, with 95% of recipients showing a significant increase in IgG antibodies, and their infants had higher antibody levels at birth and during the first six months, indicating effective maternal antibody transfer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of respiratory syncytial virus purified fusion protein-2 vaccine in pregnant women. Munoz, FM., Piedra, PA., Glezen, WP.[2022]

In a phase 2b trial involving 406 pregnant women, the RSVpreF vaccine demonstrated effective neutralizing antibody responses against RSV, with significant transplacental transfer to infants, indicating potential protection for newborns.

The vaccine was generally safe, with most side effects being mild to moderate, and the incidence of adverse events in both mothers and infants was similar to those in the placebo group, suggesting no major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. Simões, EAF., Center, KJ., Tita, ATN., et al.[2022]

A study of 43,604 pregnancies in Finland found that vaccination with the AS03 adjuvanted pandemic influenza vaccine did not increase the risk of stillbirth, neonatal death, or adverse birth outcomes, including preterm birth and low birth weight.

Specifically, among 7,839 women vaccinated during the first trimester, there were no indications of negative effects on perinatal survival or health, supporting the safety of influenza vaccination for pregnant women at any stage of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal survival and health after maternal influenza A(H1N1)pdm09 vaccination: A cohort study of pregnancies stratified by trimester of vaccination. Baum, U., Leino, T., Gissler, M., et al.[2021]

Influenza vaccination during pregnancy has been shown to be safe, with nearly 40 years of research indicating no association with adverse fetal or neonatal outcomes.

Maternal influenza vaccination provides benefits to both the fetus and neonate, which supports efforts to increase vaccination coverage among pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of influenza immunization during pregnancy for the fetus and the neonate. Bednarczyk, RA., Adjaye-Gbewonyo, D., Omer, SB.[2014]

A scoping review identified 48 studies using real-world data to evaluate the safety and effectiveness of vaccines, specifically the influenza and Tdap vaccines, administered to pregnant women and their impact on infant outcomes.

Many studies lacked detailed information on data sources and definitions, which raises concerns about the reliability of their findings, highlighting the need for more rigorous future research as new vaccines, like those for COVID-19, are introduced without prior testing in pregnant populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodologic approaches in studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women: A scoping review. Lasky, T., McMahon, AW., Hua, W., et al.[2021]

Pregnant women face higher risks of hospitalization and death from influenza, highlighting the critical need for effective vaccination strategies during pregnancy.

Pregnancy exposure registries are essential for monitoring the safety and effects of influenza vaccines and other medications in pregnant women, ensuring that data is collected on both maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancy. Khromava, A., Cohen, CJ., Mazur, M., et al.[2012]

A study involving 16,606 pregnant women found that receiving the Tdap vaccine after the 27th week of pregnancy did not significantly increase the risk of serious maternal and infant outcomes, supporting its safety during pregnancy.

While there were slight increases in the relative risks for preeclampsia/eclampsia and intrauterine infection, these were consistent with existing trends in the population and did not exceed the pre-specified safety threshold, indicating that Tdap vaccination is a safe option for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of tetanus, diphtheria, acellular pertussis (Tdap) vaccination during pregnancy. Tseng, HF., Sy, LS., Ackerson, BK., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Repeated Dose Toxicity Study and Developmental and Reproductive Toxicology Studies of a Respiratory Syncytial Virus Candidate Vaccine in Rabbits and Rats. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of respiratory syncytial virus purified fusion protein-2 vaccine in pregnant women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Perinatal survival and health after maternal influenza A(H1N1)pdm09 vaccination: A cohort study of pregnancies stratified by trimester of vaccination. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of influenza immunization during pregnancy for the fetus and the neonate. [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Methodologic approaches in studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women: A scoping review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancy. [2012]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of tetanus, diphtheria, acellular pertussis (Tdap) vaccination during pregnancy. [2022]