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.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Influenza, Human; Respiratory Syncytial Virus Infections
Intervention: RSVPreF3(120 μg); Flu Quadrivalent influenza vaccine (15 μg HA); Placebo
Intervention description: A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.; A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).; One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Observer-blind (lot-to-lot consistency) & single-blind (immunogenicity, safety and reactogenicity)
Enrollment: 1586.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus Maternal vaccine; Flu Quadrivalent influenza vaccine; Lot-to-lot consistency; Immunogenicity; Safety; Reactogenicity

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 participant
             prior to performance of any study specific procedure.

          -  Healthy female participants; as established by medical history and clinical
             examination, aged 18 to 49 years at the time of the first study intervention
             administration.

               -  Female participants of childbearing potential may be enrolled in the study, if
                  the participant:

               -  has practiced adequate contraception for 1 month prior to study intervention
                  administration, and

               -  has a negative pregnancy test on the day of study intervention administration,
                  and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 1 month after completion of the study intervention administration.

          -  No local condition precluding injection in both left and right deltoid muscles.

        Exclusion Criteria:

        Medical conditions

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study interventions;

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination;

          -  Current autoimmune disorder, for which the participant has received immune-modifying
             therapy within 6 months, before study vaccination;

          -  Hypersensitivity to latex;

          -  Acute or chronic clinically significant abnormality or poorly controlled pre-existent
             co-morbidities or any other clinical conditions, as determined by physical examination
             or medical history that, in the opinion of the investigator, might pose additional
             risk to the participant due to participation in the study;

          -  Significant or uncontrolled psychiatric illness;

          -  Recurrent history or uncontrolled neurological disorders or seizures;

          -  Documented HIV-positive participant;

          -  Body mass index > 40 kg/m^2;

          -  Any clinically significant* hematological parameter and/or biochemical laboratory
             abnormality.

             *The investigator should use his/her clinical judgment to decide which abnormalities
             are clinically significant.

          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the participant due to participation in the study.

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product other than the study
             intervention(s) during the period starting 30 days before study intervention (Day -29
             to Day 1), or planned use during the study period;

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period;

          -  Administration of immunoglobulins and/or any blood products or plasma derivatives
             during the period starting 3 months before the study intervention or planned
             administration during the study period;

          -  Chronic administration of immunosuppressants or other immune-modifying drugs during
             the period starting 3 months prior to the first study intervention dose(s). For
             corticosteroids, this will mean prednisone 5 mg/day, or equivalent. Inhaled and
             topical steroids are allowed;

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting 30 days before and ending 30 days after the vaccination
             dose;

          -  Administration of a seasonal influenza vaccine during the 6 months preceding entry
             into the study;

          -  Previous experimental vaccination against RSV.

        Prior/Concurrent clinical study experience Concurrently participating in another clinical
        study, at any time during the study period, in which the participant has been or will be
        exposed to an investigational or a non-investigational vaccine/product;

        Other exclusions

          -  Pregnant or lactating female;

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions;

          -  Alcoholism or substance use disorder within the past 24 months based on the presence
             of two or more of the following abuse criteria: hazardous use, social/interpersonal
             problems related to use, neglected major roles to use, withdrawal tolerance, use of
             larger amounts or longer, repeated attempts to quit or control use, much time spent
             using, physical or psychological problems related to use, activities given up to use,
             craving;

          -  Any study personnel or their immediate dependents, family, or household members.