Respiratory Syncytial Virus Infections
Conditions
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.
Interventions
BIOLOGICALRSVPreF3 formulation 3
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
BIOLOGICALRSVPreF3 formulation 2
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
BIOLOGICALBoostrix-ex-US
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
BIOLOGICALBoostrix-US
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
DRUGPlacebo
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Data will be collected in an observer-blind manner. In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. By observer-blind, it is meant that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity) will all be unaware of which vaccines were administered.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | From Day 1 to Day 8 | 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. |
| Percentage of Subjects With Any Solicited General AEs [Primary Study] | From Day 1 to Day 8 | 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. |
| Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 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. 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. |
| Number of Subjects With Any SAEs [Primary Study] | 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. 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. |
| Percentage of Subjects With Any Solicited Local AEs [Extension Study] | From the Day of 2nd vaccination to Day 8 post 2nd vaccination | 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. |
| Percentage of Subjects Any Solicited General AEs [Extension Period] | From the Day of 2nd vaccination to Day 8 post 2nd vaccination | 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. |
| Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 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. 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. |
| Number of Subjects With Any SAEs [Extension Period] | 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. 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. |
| RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | At Day 8 | 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. |
| RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | At Day 31 | 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. |
| RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| RSV PreF3 IgG GMCs at Day 8 [Primary Study] | At Day 8 | 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. |
| RSV PreF3 IgG GMCs at Day 31 [Primary Study] | At Day 31 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | From Day 1 to Day 8 | 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. |
| Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | From Day 1 to Day 8 | 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. |
| Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 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. 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. |
| Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 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. 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. |
| Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 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. 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. |
| Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 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. 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. |
| Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | From the Day of 2nd vaccination to Day 181 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. 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. |
| RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | At Day 8 | 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. |
| RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | At Day 31 | 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. |
| RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | At a single timepoint between 12 to 18 months post 1st vaccination | 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. |
| RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | At a single timepoint between 12 to 18 months post 1st vaccination | 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. |
| RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | At Day 31 post 2nd vaccination | 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. |
| RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | At Day 8 | 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. |
| RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | At Day 31 | 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. |
| RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | At a single timepoint between 12 to 18 months post 1st vaccination | 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. |
| RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | At a single timepoint between 12 to 18 months post 1st vaccination | 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. |
| RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | At Day 31 post 2nd vaccination | 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. |
| Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | At Screening (Day -7 to Day 1) | 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). |
| Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | At Day 31 | 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). |
| Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | At Screening (Day -7 to Day 1) | 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). |
| Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | At Day 31 | 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). |
| Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | At Screening (Day -7 to Day 1) | 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). |
| Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | At Day 31 | 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). |
| Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | At Day 31 | 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. |
| Diphtheria (Anti-D) GMCs at Screening [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| Diphtheria (Anti-D) GMCs at Day 31 [Primary Study] | At Day 31 | 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. |
| Tetanus (Anti-T) GMCs at Screening [Primary Study] | At Screening (Day -7 to Day 1) | 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. |
| Tetanus (Anti-T) GMCs at Day 31 [Primary Study] | At Day 31 | 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. |
Countries
Belgium, Canada, United States
Participant flow
Pre-assignment details
Data reported in the participant flow, baseline characteristics and the immunogenicity outcome measures of the Extension Study were only analyzed for pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) & dTpa\_Placebo\_RSV120(Pooled)\], as the two formulations of dTpa vaccine (containing 300 micrograms(μg) or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 101 |
| 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. | 103 |
| 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. | 102 |
| 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. | 102 |
| Total | 509 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Extension Study | Lost to Follow-up | 1 | 2 | 1 | 0 | 1 |
| Primary Study | ELIGIBILITY CRITERIA NOT FULFILLED (INCLUSION AND EXCLUSION CRITERIA) | 3 | 4 | 2 | 1 | 0 |
| Primary Study | Lost to Follow-up | 3 | 4 | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | RSV120_dTpa_RSV120(Pooled) | RSV120_Placebo_RSV120(Pooled) | RSV60_dTpa_RSV120(Pooled) | RSV60_Placebo_RSV120(Pooled) | dTpa_Placebo_RSV120(Pooled) | Total |
|---|---|---|---|---|---|---|
| Age, Customized | 32.1 Years STANDARD_DEVIATION 7.9 | 31.7 Years STANDARD_DEVIATION 8.4 | 30.4 Years STANDARD_DEVIATION 8.6 | 30.3 Years STANDARD_DEVIATION 8.4 | 32.6 Years STANDARD_DEVIATION 8.2 | 31.4 Years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized ASIAN | 1 Participants | 3 Participants | 2 Participants | 4 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 25 Participants |
| Race/Ethnicity, Customized OTHER Not specified | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized WHITE | 91 Participants | 90 Participants | 42 Participants | 92 Participants | 44 Participants | 202 Participants |
| Sex/Gender, Customized Female | 39 Participants | 41 Participants | 46 Participants | 41 Participants | 46 Participants | 213 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 101 | 0 / 103 | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 92 / 101 | 90 / 101 | 91 / 103 | 82 / 102 | 89 / 102 |
| serious Total, serious adverse events | 1 / 101 | 0 / 101 | 0 / 103 | 1 / 102 | 0 / 102 |
Outcome results
Primary
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.
Time frame: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs [Extension Period] | 0 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Extension Period] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs [Extension Period] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Extension Period] | 1 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Extension Period] | 0 Participants |
Primary
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.
Time frame: From Day 1 to Day 31
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs [Primary Study] | 0 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs [Primary Study] | 0 Participants |
Primary
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.
Time frame: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Population: The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Headache | 28.2 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Gastrointestinal symptoms | 10.3 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Fatigue | 25.6 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Temperature | 0 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Temperature | 0 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Fatigue | 33.3 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Gastrointestinal symptoms | 20.5 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Headache | 33.3 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Gastrointestinal symptoms | 15.2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Fatigue | 37 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Temperature | 2.2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Headache | 32.6 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Gastrointestinal symptoms | 24.4 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Temperature | 9.8 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Headache | 56.1 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Fatigue | 46.3 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Temperature | 2.3 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Gastrointestinal symptoms | 13.6 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Headache | 31.8 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects Any Solicited General AEs [Extension Period] | Fatigue | 34.1 Percentage of participants |
Primary
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.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Temperature | 2 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Headache | 44.6 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Gastrointestinal symptoms | 23.8 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Fatigue | 40.6 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Headache | 45.5 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Temperature | 4 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Gastrointestinal symptoms | 28.7 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Fatigue | 39.6 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Gastrointestinal symptoms | 27.2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Headache | 35 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Temperature | 2.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Fatigue | 37.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Gastrointestinal symptoms | 28.4 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Headache | 39.2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Fatigue | 32.4 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Temperature | 3.9 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Fatigue | 38.4 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Headache | 37.4 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Temperature | 7.1 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs [Primary Study] | Gastrointestinal symptoms | 28.3 Percentage of participants |
Primary
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.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the Solicited Safety Set (SSS) - Primary Study which consisted of all subjects from the Exposed set (ES) - Primary Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Swelling | 2 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Pain | 51.5 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Swelling | 5 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Erythema | 5.9 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Erythema | 4 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Pain | 81.2 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Erythema | 1 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Pain | 25 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Swelling | 0 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Pain | 54 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Swelling | 7 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Erythema | 5 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Pain | 76.7 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Swelling | 2.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Swelling | 1.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Erythema | 5.8 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Pain | 52.4 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Erythema | 4.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Pain | 18.6 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Swelling | 1 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Pain | 58.8 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Swelling | 4.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Erythema | 1 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Erythema | 5.9 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Swelling | 4 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Erythema | 0 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Pain | 19.2 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | RSVPreF3 (Left Arm), Swelling | 0 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Erythema | 6.1 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] | dTpa (Right Arm), Pain | 78.8 Percentage of participants |
Primary
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.
Time frame: From the Day of 2nd vaccination to Day 8 post 2nd vaccination
Population: The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Erythema | 17.9 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Swelling | 12.8 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Pain | 87.2 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Pain | 87.2 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Erythema | 10.3 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Swelling | 7.7 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Erythema | 8.7 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Pain | 80.4 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Swelling | 8.7 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Erythema | 14.6 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Swelling | 4.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Pain | 85.4 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Pain | 38.6 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Erythema | 2.3 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local AEs [Extension Study] | Swelling | 2.3 Percentage of participants |
Primary
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.
Time frame: From the Day of 2nd vaccination to Day 31 post 2nd vaccination
Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 18 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 20 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 20 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 29 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Extension Period] | 20 Percentage of participants |
Primary
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.
Time frame: From Day 1 to Day 31
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 38.6 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 34.7 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 33 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 37.3 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs [Primary Study] | 32.4 Percentage of participants |
Primary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | 875 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | 1022 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | 1135 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | 771 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study] | 1050 Titers (ED60) |
Primary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | 9836 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | 11038 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | 9214 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | 8739 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study] | 845 Titers (ED60) |
Primary
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.
Time frame: At Day 8
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | 14166 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | 14285 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | 10185 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | 10590 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study] | 783 Titers (ED60) |
Primary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | 6611 ELISA Units per milliliter (EU/mL) |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | 6751 ELISA Units per milliliter (EU/mL) |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | 7449 ELISA Units per milliliter (EU/mL) |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | 6172 ELISA Units per milliliter (EU/mL) |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study] | 6454 ELISA Units per milliliter (EU/mL) |
Primary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 [Primary Study] | 101813 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 [Primary Study] | 106082 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 [Primary Study] | 86273 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 [Primary Study] | 88938 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 [Primary Study] | 6149 EU/mL |
Primary
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.
Time frame: At Day 8
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 [Primary Study] | 156568 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 [Primary Study] | 146708 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 [Primary Study] | 101662 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 [Primary Study] | 118670 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 [Primary Study] | 5780 EU/mL |
Secondary
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).
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.26 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.27 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.23 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.46 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.55 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study] | 0.58 (IU/mL) |
Secondary
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).
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 1.3 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 1.18 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 1.76 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 2.11 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 2.2 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 3.29 (IU/mL) |
Secondary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 [Primary Study] | 1.65 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 [Primary Study] | 1.59 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Day 31 [Primary Study] | 2.42 IU/mL |
Secondary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Screening [Primary Study] | 0.35 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Screening [Primary Study] | 0.39 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Diphtheria (Anti-D) GMCs at Screening [Primary Study] | 0.36 IU/mL |
Secondary
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.
Time frame: From Day 1 to Day 31
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV120_dTpa_RSV120(US) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV120_Placebo_RSV120(US) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(US) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(US) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(US) | Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study] | 0 Participants |
Secondary
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.
Time frame: From Day 1 to Day 181
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 1 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV120_dTpa_RSV120(US) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV120_Placebo_RSV120(US) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(US) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(US) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(US) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study] | 0 Participants |
Secondary
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.
Time frame: From Day 1 to Day 181
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 1 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 0 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study] | 0 Participants |
Secondary
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.
Time frame: From the Day of 2nd vaccination to Day 181 post 2nd vaccination
Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | 0 Participants |
| RSV120_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | 0 Participants |
| RSV60_dTpa_RSV120(Pooled) | Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | 0 Participants |
| RSV60_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | 1 Participants |
| dTpa_Placebo_RSV120(Pooled) | Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period] | 0 Participants |
Secondary
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.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 36 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 22 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 46 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 4 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 28.6 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 36.7 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 6.1 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 38.8 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 23.5 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 39.2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 31.4 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 3.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 29.4 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 29.4 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 45.1 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 5.9 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 40.8 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 30.6 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 12.2 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 34.7 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 43.1 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 25.5 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 45.1 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 0 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 28.8 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 51.9 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 1.9 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 42.3 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 36.5 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 1.9 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 30.8 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 38.5 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 2 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 35.3 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 33.3 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 27.5 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Headache | 34 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Fatigue | 42 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Temperature | 2 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] | Gastrointestinal symptoms | 26 Percentage of participants |
Secondary
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.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 6 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 2 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 6 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 86 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 46 Percentage of participants |
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 4 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 53.1 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 18.4 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 6.1 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 4.1 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 2 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 0 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 5.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 3.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 52.9 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 88.2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 2 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 3.9 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 60.8 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 23.5 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 16.3 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 0 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 0 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 6.1 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 79.6 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 6.1 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 2 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 56.9 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 3.9 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 5.9 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 76.5 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 3.9 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 7.8 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 0 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 54.9 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 31.4 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 5.9 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 0 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 7.7 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 0 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 1.9 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 65.4 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 5.8 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 51.9 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 9.8 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 7.8 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 0 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 56.9 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 0 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 13.7 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Erythema | 6 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Pain | 78 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Swelling | 0 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Right Arm, Swelling | 2 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Erythema | 0 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] | Left Arm, Pain | 22 Percentage of participants |
Secondary
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.
Time frame: From Day 1 to Day 31
Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 38 Percentage of participants |
| RSV120_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 36.7 Percentage of participants |
| RSV60_dTpa_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 39.2 Percentage of participants |
| RSV60_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 43.1 Percentage of participants |
| dTpa_Placebo_RSV120(Pooled) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 33.3 Percentage of participants |
| RSV120_dTpa_RSV120(US) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 39.2 Percentage of participants |
| RSV120_Placebo_RSV120(US) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 32.7 Percentage of participants |
| RSV60_dTpa_RSV120(US) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 26.9 Percentage of participants |
| RSV60_Placebo_RSV120(US) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 31.4 Percentage of participants |
| dTpa_Placebo_RSV120(US) | Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study] | 31.4 Percentage of participants |
Secondary
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).
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 237.1 (IU/mL) |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 309.5 (IU/mL) |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 57.36 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 214.7 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 210.6 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 54.95 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 79.16 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 303.6 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 395.1 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 186.5 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 43.76 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 217.7 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 176.7 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 36.98 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 228.1 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PT | 44.99 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-PRN | 331.4 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | anti-FHA | 232.9 (IU/mL) |
Secondary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-FHA | 210.3 IU/mL |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PT | 50.10 IU/mL |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PRN | 259.6 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-FHA | 192.9 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PT | 45.08 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PRN | 221.3 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PT | 59.51 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-PRN | 361.1 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] | Anti-FHA | 265.6 IU/mL |
Secondary
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).
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 32.8 International Units Per mL (IU/mL) |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 7.39 International Units Per mL (IU/mL) |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 43.2 International Units Per mL (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 34.5 International Units Per mL (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 7.64 International Units Per mL (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 39 International Units Per mL (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 29.3 International Units Per mL (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 6.65 International Units Per mL (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 28.1 International Units Per mL (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 31 International Units Per mL (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 7.55 International Units Per mL (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 42.1 International Units Per mL (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 29.6 International Units Per mL (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 5.66 International Units Per mL (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 40.1 International Units Per mL (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PT | 7.17 International Units Per mL (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-PRN | 28.7 International Units Per mL (IU/mL) |
| RSV120_dTpa_RSV120(US) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] | anti-FHA | 28 International Units Per mL (IU/mL) |
Secondary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-FHA | 31.9 IU/mL |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PT | 7.47 IU/mL |
| RSV120_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PRN | 42.6 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-FHA | 31.9 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PT | 6.56 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PRN | 39.6 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PT | 6.90 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-PRN | 28.4 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] | Anti-FHA | 28.6 IU/mL |
Secondary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 9838 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 10800 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 8754 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 8141 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 767 Titers (ED60) |
| RSV120_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 9834 Titers (ED60) |
| RSV120_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 11276 Titers (ED60) |
| RSV60_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 9698 Titers (ED60) |
| RSV60_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 9395 Titers (ED60) |
| dTpa_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study] | 930 Titers (ED60) |
Secondary
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.
Time frame: At Day 31 post 2nd vaccination
Population: The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | 3892 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | 5071 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | 4779 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | 4920 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study] | 8200 Titers (ED60) |
Secondary
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.
Time frame: At Day 8
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 14523 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 15458 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 10677 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 11128 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 698 Titers (ED60) |
| RSV120_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 13818 Titers (ED60) |
| RSV120_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 13264 Titers (ED60) |
| RSV60_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 9715 Titers (ED60) |
| RSV60_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 10077 Titers (ED60) |
| dTpa_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study] | 884 Titers (ED60) |
Secondary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 777 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 1009 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 989 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 777 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 956 Titers (ED60) |
| RSV120_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 981 Titers (ED60) |
| RSV120_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 1035 Titers (ED60) |
| RSV60_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 1298 Titers (ED60) |
| RSV60_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 765 Titers (ED60) |
| dTpa_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study] | 1154 Titers (ED60) |
Secondary
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.
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2034 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2869 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 3086 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2200 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 675 Titers (ED60) |
| RSV120_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2014 Titers (ED60) |
| RSV120_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2960 Titers (ED60) |
| RSV60_dTpa_RSV120(US) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2474 Titers (ED60) |
| RSV60_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 2569 Titers (ED60) |
| dTpa_Placebo_RSV120(US) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 969 Titers (ED60) |
Secondary
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.
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 2027 Titers (ED60) |
| RSV120_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 2889 Titers (ED60) |
| RSV60_dTpa_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 2885 Titers (ED60) |
| RSV60_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 2302 Titers (ED60) |
| dTpa_Placebo_RSV120(Pooled) | RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 759 Titers (ED60) |
Secondary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 94254 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 95113 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 84509 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 81915 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 5600 EU/mL |
| RSV120_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 109978 EU/mL |
| RSV120_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 118052 EU/mL |
| RSV60_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 88075 EU/mL |
| RSV60_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 96727 EU/mL |
| dTpa_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 6739 EU/mL |
Secondary
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.
Time frame: At Day 31 post 2nd vaccination
Population: The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | 41399 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | 42943 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | 43977 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | 45680 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study] | 86934 (IU/mL) |
Secondary
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.
Time frame: At Day 8
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 155721 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 143104 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 100064 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 123475 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 5523 EU/mL |
| RSV120_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 157403 EU/mL |
| RSV120_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 150184 EU/mL |
| RSV60_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 103286 EU/mL |
| RSV60_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 114053 EU/mL |
| dTpa_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study] | 6061 EU/mL |
Secondary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6240 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6524 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 7237 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6106 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 5907 EU/mL |
| RSV120_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6987 EU/mL |
| RSV120_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6978 EU/mL |
| RSV60_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 7662 EU/mL |
| RSV60_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 6240 EU/mL |
| dTpa_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study] | 7051 EU/mL |
Secondary
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.
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 18832 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 20894 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 23189 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 20720 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 5014 EU/mL |
| RSV120_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 18127 EU/mL |
| RSV120_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 19641 EU/mL |
| RSV60_dTpa_RSV120(US) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 22905 EU/mL |
| RSV60_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 22233 EU/mL |
| dTpa_Placebo_RSV120(US) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study] | 6811 EU/mL |
Secondary
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.
Time frame: At a single timepoint between 12 to 18 months post 1st vaccination
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 18570 EU/mL |
| RSV120_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 20605 EU/mL |
| RSV60_dTpa_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 23102 EU/mL |
| RSV60_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 21152 EU/mL |
| dTpa_Placebo_RSV120(Pooled) | RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study] | 5540 EU/mL |
Secondary
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).
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 5.57 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 5.3 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 6.74 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 6.09 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 6.27 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] | 8.32 (IU/mL) |
Secondary
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.
Time frame: At Day 31
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 [Primary Study] | 5.83 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 [Primary Study] | 5.76 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Day 31 [Primary Study] | 7.49 IU/mL |
Secondary
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).
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 1.14 (IU/mL) |
| RSV120_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 1.1 (IU/mL) |
| RSV60_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 0.88 (IU/mL) |
| RSV60_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 1.35 (IU/mL) |
| dTpa_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 1.56 (IU/mL) |
| RSV120_dTpa_RSV120(US) | Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study] | 1.68 (IU/mL) |
Secondary
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.
Time frame: At Screening (Day -7 to Day 1)
Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV120_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening [Primary Study] | 1.24 IU/mL |
| RSV120_Placebo_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening [Primary Study] | 1.31 IU/mL |
| RSV60_dTpa_RSV120(Pooled) | Tetanus (Anti-T) GMCs at Screening [Primary Study] | 1.22 IU/mL |