Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

NCT05045144 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.

Interventions

  • COMBINATION_PRODUCT Placebo
  • COMBINATION_PRODUCT RSVPreF3(120 μg)
  • COMBINATION_PRODUCT Flu Quadrivalent influenza vaccine (15 μg HA)

Study Locations (20)

Quebec

  • GSK Investigational Site — Mirabel
  • GSK Investigational Site — Pointe-Claire
  • GSK Investigational Site — Québec
  • GSK Investigational Site — Saint-Charles-Borromée
  • GSK Investigational Site — Sherbrooke

Other

  • GSK Investigational Site — Espoo
  • GSK Investigational Site — Helsinki
  • GSK Investigational Site — Helsinki
  • GSK Investigational Site — Jarvenpaa

Ontario

  • GSK Investigational Site — London
  • GSK Investigational Site — Sarnia
  • GSK Investigational Site — Toronto

British Columbia

  • GSK Investigational Site — Surrey
  • GSK Investigational Site — Vancouver

Florida

  • GSK Investigational Site — West Palm Beach

Georgia

  • GSK Investigational Site — Stockbridge

Illinois

  • GSK Investigational Site — Peoria

Missouri

  • GSK Investigational Site — Springfield

Trial Details

FieldValue
Enrollment Target 1,586 participants
Start Date 2021-10-26
Est. Completion 2022-06-06
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05045144

The ClinicalTrials.gov registry entry for NCT05045144 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,586 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05045144 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Quebec, Other, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05045144 about?

NCT05045144 is a clinical study titled "A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.". The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from c...

What is the current status of trial NCT05045144?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,586 participants. The study started on 2021-10-26. Estimated completion is 2022-06-06.

What conditions does trial NCT05045144 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05045144?

The interventions under investigation include: Placebo (COMBINATION_PRODUCT), RSVPreF3(120 μg) (COMBINATION_PRODUCT), Flu Quadrivalent influenza vaccine (15 μg HA) (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05045144?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05045144 being conducted?

This trial has 20 study locations across Florida, Georgia, Illinois, Missouri, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial