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

A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 formulation 3; Biological: Boostrix-ex-US; Drug: Placebo; Biological: RSVPreF3 formulation 2; Biological: Boostrix-US

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
• Canada
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • London, Ontario, Canada, N5W 6A2
      • GSK Investigational Site
• United States
  • Florida
    • Miami, Florida, United States, 33143
      • GSK Investigational Site
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV120_dTpa_RSV120(Pooled); Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were 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.; Biological: Boostrix-US; One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
Placebo Comparator: RSV120_Placebo_RSV120(Pooled); Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were 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: RSV60_dTpa_RSV120(Pooled); Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were 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.; 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: RSV60_Placebo_RSV120(Pooled); Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were 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.; Biological: RSVPreF3 formulation 2; One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
Placebo Comparator: dTpa_Placebo_RSV120(Pooled); Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were 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.; Biological: Boostrix-US; One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]	Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs [Primary Study]	Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs [Primary Study]	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. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From Day 1 to Day 31
Number of Subjects With Any SAEs [Primary Study]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From Day 1 to Day 31
Percentage of Subjects With Any Solicited Local AEs [Extension Study]	Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects Any Solicited General AEs [Extension Period]	Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Percentage of Subjects With Any Unsolicited AEs [Extension Period]	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. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From the Day of 2nd vaccination to Day 31 post 2nd vaccination
Number of Subjects With Any SAEs [Extension Period]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From the Day of 2nd vaccination to Day 31 post 2nd vaccination
RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Screening (Day -7 to Day 1)
RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 8
RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 31
RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 8
RSV PreF3 IgG GMCs at Day 31 [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]	Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.	From Day 1 to Day 8
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]	Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.	From Day 1 to Day 8
Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]	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. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.	From Day 1 to Day 31
Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.	From Day 1 to Day 31
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From Day 1 to Day 181
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.	From Day 1 to Day 181
Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]	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. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.	From the Day of 2nd vaccination to Day 181 post 2nd vaccination
RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At Screening (Day -7 to Day 1)
RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At Day 8
RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At Day 31
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At a single timepoint between 12 to 18 months post 1st vaccination
RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]	Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 31 post 2nd vaccination
RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At Screening (Day -7 to Day 1)
RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.	At Day 8
RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.	At Day 31
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.	At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At a single timepoint between 12 to 18 months post 1st vaccination
RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]	Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled), RSV120_Placebo_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.	At Day 31 post 2nd vaccination
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Day 31
Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Day 31
Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).	At Day 31
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study]	Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Screening (Day -7 to Day 1)
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study]	Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Day 31
Diphtheria (Anti-D) GMCs at Screening [Primary Study]	Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Screening (Day -7 to Day 1)
Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]	Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Day 31
Tetanus (Anti-T) GMCs at Screening [Primary Study]	Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Screening (Day -7 to Day 1)
Tetanus (Anti-T) GMCs at Day 31 [Primary Study]	Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.	At Day 31

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 209141; 2019-002258-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
• IPD Sharing Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No