A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: XRSV formulation 3_dTpa Group Subjects randomized to the XRSV formulation 3_dTpa group receive a single dose of RSVPreF3 formulation 3 vaccine in the left arm, a single dose of dTpa vaccine in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a second dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: Boostrix-ex-US
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
|
| Placebo Comparator: XPlacebo_RSV formulation 3 Group Subjects randomized to the XPlacebo_RSV formulation 3 group receive a single dose of RSVPreF3 formulation 3 vaccine in the left arm, a single dose of Placebo in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a second dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
| Experimental: XRSV formulation 2_dTpa Group Subjects randomized to the XRSV formulation 2_dTpa group receive a single dose of RSVPreF3 formulation 2 vaccine in the left arm, a single dose of dTpa vaccine in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a second dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: RSVPreF3 formulation 2
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Biological: Boostrix-ex-US
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
|
| Placebo Comparator: XPlacebo_RSV formulation 2 Group Subjects randomized to the XPlacebo_RSV formulation 2 group receive a single dose of RSVPreF3 formulation 2 vaccine in the left arm, a single dose of Placebo in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a second dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: RSVPreF3 formulation 2
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
| Placebo Comparator: XPlacebo_dTpa Group Subjects randomized to the XPlacebo_dTpa group receive a single dose of Placebo in the left arm, a single dose of dTpa vaccine in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: Boostrix-ex-US
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
| Experimental: URSV formulation 3_dTpa Group Subjects randomized to the URSV formulation 3_dTpa group receive a single dose of RSVPreF3 formulation 3 vaccine in the left arm, a single dose of dTpa vaccine in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: Boostrix-US
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
|
| Placebo Comparator: UPlacebo_RSV formulation 3 Group Subjects randomized to the UPlacebo_RSV formulation 3 group receive a single dose of RSVPreF3 formulation 3 vaccine in the left arm, a single dose of Placebo in the right arm during the vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
| Experimental: URSV formulation 2_dTpa Group Subjects randomized to the URSV formulation 2_dTpa group receive a single dose of RSVPreF3 formulation 2 vaccine in the left arm, a single dose of dTpa vaccine in the right arm during vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: RSVPreF3 formulation 2
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Biological: Boostrix-US
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
|
| Placebo Comparator: UPlacebo_RSV formulation 2 Group Subjects randomized to the UPlacebo_RSV formulation 2 group receive a single dose of RSVPreF3 formulation 2 vaccine in the left arm, a single dose of Placebo in the right arm during vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: RSVPreF3 formulation 2
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
| Placebo Comparator: UPlacebo_dTpa Group Subjects randomized to the UPlacebo_dTpa group receive a single dose of Placebo in the left arm, a single dose of dTpa vaccine in the right arm during vaccination 1 phase and are followed up until Day 181. The subjects that agree to participate in the study extension receive a single dose of RSVPreF3 formulation 3 (12 to 18 months post 1st vaccination) vaccine in the non-dominant arm during the vaccination 2 phase and are followed up until the study end. |
Biological: RSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
Biological: Boostrix-US
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
Drug: Placebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects with at least one solicited local adverse event (AE) for each study group, after the 1st vaccination [From Day 1 to Day 8]
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Solicited local AEs, at the site of injection in both limbs, are: pain, redness and swelling.
- Percentage of subjects with at least one solicited general AE for each study group, after the 1st vaccination [From Day 1 to Day 8]
Solicited general AEs are: fatigue, fever, gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain, headache.
- Percentage of subjects with any unsolicited AEs for each study group, after the 1st vaccination [From Day 1 to Day 31]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
- Percentage of subjects with at least one serious adverse event (SAE) for each study group, after the 1st vaccination [From Day 1 to Day 31]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
- Percentage of subjects with at least one solicited local AE for each study group, after the 2nd vaccination [From the Day of 2nd vaccination to Day 8 post 2nd vaccination]
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Solicited local AEs, at the site of injection in both deltoids, are: pain, redness and swelling.
- Percentage of subjects with at least one solicited general AE for each study group, after the 2nd vaccination [From the Day of 2nd vaccination to Day 8 post 2nd vaccination]
Solicited general AEs are: fatigue, fever, gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain, headache.
- Percentage of subjects with any unsolicited AEs for each study group, after the 2nd vaccination [From the Day of 2nd vaccination to Day 31 post 2nd vaccination]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
- Percentage of subjects with at least one SAE for each study group, after the 2nd vaccination [From the Day of 2nd vaccination to Day 31 post 2nd vaccination]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
- Humoral immune response in terms of RSV A neutralizing antibody Geometric Mean Titers (GMTs) for each group, at Screening [From Day -7 to Day 1]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV A neutralizing antibody GMTs for each group at Day 8, after the 1st vaccination [At Day 8]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV A neutralizing antibody GMTs for each group at Day 31, after the 1st vaccination [At Day 31]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- Humoral immune response in terms of RSV PreF3 IgG antibody Geometric Mean Concentration (GMCs) for each group, at Screening [From Day -7 to Day 1]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- RSV PreF3 IgG GMCs for each group, at Day 8, after the 1st vaccination [At Day 8]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- RSV PreF3 IgG GMCs for each group, at Day 31, after the 1st vaccination [At Day 31]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
Secondary Outcome Measures
- Percentage of subjects with at least one solicited local AE for each group and formulation, after the 1st vaccination [From Day 1 to Day 8]
Solicited local AEs, at the site of injection in both limbs, are: pain, redness and swelling.
- Percentage of subjects with at least one solicited general AE for each group and formulation, after the 1st vaccination [From Day 1 to Day 8]
Solicited general AEs are: fatigue, fever, gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain, headache.
- Percentage of subjects with any unsolicited AE, for each group and formulation, after the 1st vaccination [From Day 1 to Day 31]
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
- Percentage of subjects with at least one SAE from 1st vaccination to Day 31, for each formulation [From Day 1 to Day 31]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
- Percentage of subjects with at least one SAE from 1st vaccination to Day 181, for pooled formulations [From Day 1 to Day 181]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This outcome measure evaluates the safety of 2 dose levels of RSVPreF3 when given alone and co-administered with dTpa compared to dTpa_Placebo groups.
- Percentage of subjects with at least one report of SAE from 1st vaccination to Day 181, for each formulation [From Day 1 to Day 181]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This outcome measure evaluates the safety of 2 dose levels of RSVPreF3 when given alone and co-administered.
- Percentage of subjects with at least one SAE from 1st vaccination to Day 181, for pooled all groups receiving RSVPreF3 [From Day 1 to Day 181]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This outcome measure evaluates the safety of all groups receiving RSVPreF3 vaccine.
- Percentage of subjects with at least one SAE from 2nd vaccination to Day 181 post 2nd vaccination [From the Day of 2nd vaccination to Day 181 post 2nd vaccination]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This outcome measure evaluates the safety of 2 dose levels of RSVPreF3 when given alone and co-administered.
- Humoral immune response in terms of RSV A neutralizing GMTs for each formulation, at Screening [From Day -7 to Day 1]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV A neutralizing GMTs for each formulation at Day 8, after the 1st vaccination [At Day 8]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV A neutralizing GMTs for each formulation at Day 31, after the 1st vaccination [At Day 31]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV A neutralizing GMTs for each formulation, at a single timepoint between 12 to 18 months post 1st vaccination [At a single timepoint between 12 to 18 months post 1st vaccination]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- Humoral immune response in terms of RSV PreF3 IgG antibody GMCs for each formulation, at Screening [From Day -7 to Day 1]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- RSV PreF3 IgG antibody GMCs for each formulation, after the 1st vaccination [At Day 8]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- RSV PreF3 IgG antibody GMCs for each formulation, after the 1st vaccination [At Day 31]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- RSV PreF3 IgG antibody GMCs for each formulation, at a single timepoint between 12 to 18 months post 1st vaccination [At a single timepoint between 12 to 18 months post 1st vaccination]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
- Humoral immune response to the pertussis components of the dTpa vaccine in terms of antibody GMCs against pertussis toxoid (anti-PT), filamentous hemagglutinin (anti-FHA) and pertactin (anti-PRN) for each formulation, at Screening [From Day -7 to Day 1]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN are performed by ELISA. The corresponding antibody concentrations are expressed in IU/mL. The cut-off value for the assay for anti-PT is 2.693 IU/mL, for anti-FHA is 2.046 IU/mL and for anti-PRN is 2.187 IU/mL.
- Anti-PT, anti-FHA and anti-PRN concentrations, for each formulation, after the 1st vaccination [At Day 31]
Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN are performed by ELISA. The corresponding antibody concentrations are expressed in IU/mL. The cut-off value for the assay for anti-PT is 2.693 IU/mL, for anti-FHA is 2.046 IU/mL and for anti-PRN is 2.187 IU/mL.
- Humoral immune response to the Diphtheria (D) component of the dTpa vaccine in terms of antibody GMCs against D toxoid (anti-D), for each formulation, at Screening [From Day -7 to Day 1]
Serological assays for the determination of IgG antibodies against Corynebacterium diphtheriae, anti-D, are performed by ELISA. The corresponding antibody concentration is expressed in IU/mL. The cut-off value for the assay is 0.057 IU/mL.
- Anti-D antibody GMCs for each formulation, after the 1st vaccination [At Day 31]
Serological assays for the determination of IgG antibodies against Corynebacterium diphtheriae, anti-D, are performed by ELISA. The corresponding antibody concentration is expressed in IU/mL. The cut-off value for the assay is 0.057 IU/mL.
- Anti-T (Tetanus) antibody GMCs for each formulation, at Screening [From day -7 to Day 1]
Serological assays for the determination of IgG antibodies against Clostridium tetani, anti-T, are performed by ELISA. The corresponding antibody concentration is expressed in IU/mL. The cut-off value for the assay is 0.043 IU/mL.
- Anti-T antibody GMCs for each formulation, after the 1st vaccination [At Day 31]
Serological assays for the determination of IgG antibodies against Clostridium tetani, anti-T, are performed by ELISA. The corresponding antibody concentration is expressed in IU/mL. The cut-off value for the assay is 0.043 IU/mL.
- RSV A neutralizing GMTs for each formulation, at Day 31 post 2nd vaccination [At Day 31 post 2nd vaccination]
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
- RSV PreF3 IgG antibody GMCs for each formulation, at 31 days post 2nd vaccination [At Day 31 post 2nd vaccination]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The cut-off value for the assay is 25 ELU/mL.
Eligibility Criteria
Criteria
Inclusion Criteria:
Primary study
-
Subjects 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 subject prior to performance of any study specific procedure.
-
Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
-
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-
has practiced adequate contraception for 30 days prior to primary vaccination, and
-
has a negative pregnancy test on the day of primary vaccination, and
-
has agreed to continue adequate contraception for 90 days after completion of the vaccination.
-
No local condition precluding injection in both left and right deltoid muscles.
Extension study
-
Completed primary study and received 1st dose of a study vaccine.
-
Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension.
All subjects must satisfy ALL the following criteria:
-
Subjects who can and will comply with the requirements of the protocol.
-
Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
-
Female subjects of childbearing potential are eligible for the extension, if the subject:
-
has practiced adequate contraception for 30 days prior to 2nd vaccination
-
has a negative pregnancy test with results available on the day of 2nd vaccination
-
has agreed to continue adequate contraception for 90 days after completion of the 2nd vaccination.
Exclusion Criteria:
Primary study
Medical conditions
-
History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;
-
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
-
Hypersensitivity to latex;
-
Major congenital defects;
-
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
-
Significant/uncontrolled psychiatric illness;
-
Recurrent history/uncontrolled neurological disorders/seizures;
-
Documented HIV-positive subject;
-
History of/current autoimmune disease;
-
Body mass index (BMI)>40 kg/m^2;
-
Any clinically significant hematological parameter and/or biochemical laboratory abnormality.
-
Any other clinical condition that might pose additional risk to the subject due to participation in the study.
Prior/Concomitant therapy
-
Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before 1st vaccination, or planned use during the study;
-
Administration of long-acting immune-modifying drugs at any time during the study;
-
Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st vaccination or planned administration during the study;
-
Chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to 1st vaccine 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 study 1st vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination;
-
Administration of a vaccine containing diphtheria, tetanus/pertussis antigens/diphtheria and tetanus toxoids within the previous 5 years;
-
Previous experimental vaccination against RSV;
Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;
Other exclusions
-
Pregnant/lactating female;
-
Female planning to become pregnant/planning to discontinue contraceptive precautions;
-
History of alcoholism, drug abuse and/or use disorder within the past 2 years;
-
Any study personnel/their immediate dependents, family/household members.
Extension study
Medical conditions
-
History of any reaction/hypersensitivity likely to be exacerbated by any component of the vaccines;
-
Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
-
Hypersensitivity to latex;
-
Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
-
Significant/uncontrolled psychiatric illness;
-
Recurrent history/uncontrolled neurological disorders/seizures;
-
Documented HIV-positive subject;
-
History of/current autoimmune disease;
-
BMI>40 kg/m^2;
-
Participants who experienced any SAE judged to be possibly or probably related to 1st dose of RSVPreF3, including hypersensitivity reactions.
-
Any other clinical condition that might pose additional risk to the subject due to participation in the study.
Prior/Concomitant therapy
-
Use of any investigational/non-registered product other than the study vaccines during the period starting 30 days before the 2nd vaccination, or planned use during the 6-month study extension;
-
Administration of long-acting immune-modifying drugs at any time during the study;
-
Administration of immunoglobulins and/or any blood products/plasma derivatives during the period starting 3 months before the 1st dose of study vaccines/planned administration during the study;
-
Chronic administration of immunosuppressants or other immune-modifying drugs during the starting 3 months prior to the 1st vaccine 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 study 2nd vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before/after study vaccination.
Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study, in which the subject has been/will be exposed to an investigational/a non-investigational vaccine/product;
Other exclusions
-
Pregnant/lactating female at the time of Visit 4;
-
Female planning to become pregnant/planning to discontinue contraceptive precautions;
-
History of alcoholism, drug abuse and/or use disorder within the past 2 years;
-
Any study personnel/their immediate dependents, family/household members.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Miami | Florida | United States | 33143 |
| 2 | GSK Investigational Site | Lenexa | Kansas | United States | 66219 |
| 3 | GSK Investigational Site | Rochester | New York | United States | 14609 |
| 4 | GSK Investigational Site | Seattle | Washington | United States | 98105 |
| 5 | GSK Investigational Site | Gent | Belgium | 9000 | |
| 6 | GSK Investigational Site | Leuven | Belgium | 3000 | |
| 7 | GSK Investigational Site | Truro | Nova Scotia | Canada | B2N 1L2 |
| 8 | GSK Investigational Site | London | Ontario | Canada | N5W 6A2 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 209141
- 2019-002258-22