A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a single intramuscular dose of the investigational respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine during subsequent uncomplicated pregnancy in maternal participants, 18 to 49 years of age (YOA), who have previously received the RSV MAT vaccine or placebo in the RSV MAT-004 (NCT04126213), RSV MAT-009 (NCT04605159) and RSV MAT-012 (NCT04980391) primary studies.

Key facts

Study ID

NCT05229068

Run by

GlaxoSmithKline

People needed

0

Starts

2022-03-11

Expected to finish

2024-10-24

Last updated by the study team

2022-04-07

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Maternal participants
• Only those pregnant participants who received a single 120 µg dose of RSV MAT vaccine or placebo in the RSV MAT-004, RSV MAT-009 or RSV MAT-012 studies OR healthy pregnant participants who had at least one prior live birth and have not received any RSV vaccine in the past.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participants prior to performance of any study-specific procedure. The informed consent given at screening should (consistent with local regulations/guidelines) either:
• include consent for both the maternal participant's participation and participation of the infant after the infant's birth, or
• include consent for the maternal participant's participation and expressed willingness to consider permitting the infant to take part after the infant's birth (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth).
• Both mother and father should consent if local regulations/guidelines require it.
• In good general maternal health as established by medical history and clinical examination before entering into the study.
• Participants between and including 18 and 49 YOA, inclusive at the time of consent.
• Pre-pregnancy body mass index (based on participant's report) 17 to 39.9 kg/m\^2, inclusive.
• Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome).
• Pregnant females at 24\^0/7 to 36\^0/7 weeks of gestation at the time of study intervention administration (Visit 1), as established by:
• last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
• First or second trimester U/S only, if LMP is unknown/uncertain.
• Certain LMP, corroborated by a U/S performed after 28 weeks of gestation is also acceptable.
• NOTE: If pregnancy resulted from assisted reproductive technologies, LMP date may be replaced by IUI (intrauterine insemination) or ET (embryo-transfer) date.
• No fetal genetic abnormalities (based on genetic testing, if performed).
• No significant congenital malformations conducted at or beyond 18 weeks of gestation.
• Participants who are willing to provide cord blood.
• Participants who do not plan to give their offspring for adoption or place the child in care.
• Participants who plan to reside in the study area for at least one year after delivery.
• Willing to have their infant followed-up after delivery for a period of 12 months.
• Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be enrolled if they meet all inclusion criteria and none of the exclusion criteria.
• Infant participants
• Live-born from the study pregnancy.

You may not qualify if…

• Maternal participants
• Medical conditions
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
• Hypersensitivity to latex.
• Acute or chronic clinically significant abnormality or poorly controlled pre-existing condition or any other clinical conditions.
• Subjects who have received 2 or more doses of any RSV vaccine in the past.
• Significant complications in the current pregnancy such as:
• Gestational hypertension at ≥20 weeks of gestation in the absence of proteinuria in a woman with a previously normal blood pressure.
• Gestational diabetes which is not controlled by medication, diet and/or exercise
• Pre-eclampsia
• Eclampsia
• Intrauterine Growth Restriction/Fetal Growth Restriction
• Placenta previa
• Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities
• Polyhydramnios
• Oligohydramnios
• Preterm labor or history of preterm labor in the current pregnancy.
• Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery
• Cholestasis
• Other pregnancy-related complications
• History of 2 or more prior stillbirths or neonatal deaths, or history of 2 or more preterm births at ≤ 34 weeks gestation, or 3 or more consecutive spontaneous abortions.
• Significant structural abnormalities of the uterus or cervix.
• Known human immunodeficiency virus infection, as assessed by local standard of care serologic tests.
• Known or suspected hepatitis B or C virus infection.
• Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex.

Where it is running

• GSK Investigational Site — Missoula, Montana, United States
• GSK Investigational Site — Norfolk, Nebraska, United States

Full record on ClinicalTrials.gov

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