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Virus Vaccine

RSV MAT for Respiratory Syncytial Virus (GRACE Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth to month 12 post birth

Awards & highlights

GRACE Trial Summary

This trial is no longer enrolling or vaccinating participants, but will continue to monitor those who have already been enrolled. The purpose of the study was to see if the vaccine prevents RSV-associated lower respiratory tract illnesses in infants, and to evaluate the safety of the vaccine for both mothers and infants.

Eligible Conditions

Respiratory Syncytial Virus (RSV)
Respiratory Syncytial Virus

GRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth to month 12 post birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from birth to month 12 post birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth to month 12 post birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of infant participants with at least one SAE, AE leading to study termination or MAE, from birth up to 12 months after birth

Number of infant participants with at least one SAE, AE leading to study termination or Medically Attended AE (MAE), from birth up to 6 months after birth

Number of infant participants with medically assessed, RSV-associated LRTIs, up to 6 months of age

Secondary outcome measures

Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations

Humoral immune response in terms of RSV-A neutralizing antibody GMTs in infant participants, at specified timepoints.

Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs) in maternal participants, at specified timepoints

+17 more

GRACE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RSV_MAT GroupExperimental Treatment1 Intervention

Maternal participants randomized to the RSV_MAT Group will receive a single dose of RSV MAT vaccine at day 1, via the intramuscular route; the preferred injection site will be the deltoid region of the non-dominant arm.

Group II: Control GroupPlacebo Group1 Intervention

Maternal participants randomized to the Control Group will receive a single dose of Placebo at day 1, via the intramuscular route; the preferred injection site will be the deltoid region of the non-dominant arm.

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,753 Previous Clinical Trials

8,058,880 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,133,352 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people over the age of 69 sign up for this experiment?

"The target participants for this clinical trial are adults aged 18-49."

Answered by AI

How many different hospitals or research centers are a part of this trial?

"To make participation as convenient as possible for patients, this trial is running in 52 locations, including Johnson City, Irving and Metairie."

Answered by AI

Has the RSV MAT undergone FDA approval?

"RSV MAT has received a 3 from our Power team. This is due to the fact that this is a Phase 3 trial, thus there is some data affirming its efficacy and multiple rounds of data affirming its safety."

Answered by AI

Recent research and studies

The Lancet Global HealthJournal

Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia

Ginsburg, Amy Sarah, and Padmini Srikantiah. 2021. “Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia”. The Lancet Global Health. Elsevier BV. doi:10.1016/s2214-109x(21)00455-1.

clinicaltrials.govStudy

A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

2020. "A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04605159.