Respiratory Syncytial Virus Infections
Conditions
Keywords
Vaccine, Immunogenicity, Safety, Respiratory syncytial virus (RSV), Reactogenicity
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
Interventions
BIOLOGICALRSV vaccine GSK3003895A (formulation 1)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
BIOLOGICALRSV vaccine GSK3003898A (formulation 2)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
BIOLOGICALRSV vaccine GSK3003899A (formulation 3)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
BIOLOGICALBoostrix
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * Has practiced adequate contraception for 30 days prior to study vaccination, and * Has a negative pregnancy test on the day of study vaccination, and * Has agreed to continue adequate contraception during the study period.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/ product. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * 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 vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination. * Previous experimental vaccination against RSV. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines. * History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component of Boostrix. * History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine. * History of any neurological disorders or seizures * History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus. * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of or current autoimmune disease. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality. * Malignancy within previous 5 years or lymphoproliferative disorder. * Current alcohol and/or drug abuse. * Acute disease and/ or fever at the time of enrolment. * Hypersensitivity to latex. * Pregnant or lactating female. * Planned move to a location that will prohibit participating in the trial until study end. * Any other condition that the investigator judges may interfere with study procedures or findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titres of RSV-A Neutralizing Antibodies | At Day 0 pre-vaccination | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60). |
| Number of Subjects With Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm). |
| Number of Subjects With Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-Day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From vaccination at Day 0, up to Day 30 post-vaccination | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Palivizumab Competing Antibodies (PCA) | At Day 0 pre-vaccination | Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Concentrations of PCA | At Day 30 post-vaccination | PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL). |
| Number of Subjects With SAEs | Up to study end at Day 360 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Titres of RSV-A Neutralizing Antibodies | At Day 60 post-vaccination | RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60). |
Countries
Australia, Czechia, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK3003891A 30 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | 126 |
| GSK3003891A 60 Non-adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | 124 |
| GSK3003891A 60 Adjuvanted Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | 125 |
| Boostrix Group Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0. | 125 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 12 | 6 | 4 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Boostrix Group | GSK3003891A 60 Adjuvanted Group | GSK3003891A 60 Non-adjuvanted Group | GSK3003891A 30 Non-adjuvanted Group |
|---|---|---|---|---|---|
| Age, Continuous | 29.25 Years STANDARD_DEVIATION 7.73 | 29.2 Years STANDARD_DEVIATION 7.9 | 29.1 Years STANDARD_DEVIATION 7.4 | 29.5 Years STANDARD_DEVIATION 8.2 | 29.2 Years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized African Heritage / African American | 30 Participants | 9 Participants | 9 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 4 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 12 Participants | 4 Participants | 6 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 2 Participants | 5 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White-Arabic / North African Heritage | 7 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Caucasian/European Heritage | 431 Participants | 108 Participants | 97 Participants | 114 Participants | 112 Participants |
| Sex: Female, Male Female | 500 Participants | 125 Participants | 125 Participants | 124 Participants | 126 Participants |
| Sex: Female, Male Male | 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 |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 124 | 0 / 125 | 0 / 125 |
| other Total, other adverse events | 93 / 126 | 88 / 124 | 112 / 125 | 109 / 125 |
| serious Total, serious adverse events | 3 / 126 | 3 / 124 | 6 / 125 | 2 / 125 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From vaccination at Day 0, up to Day 30 post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Boostrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Temp. | 7 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Temp. | 5 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Headache | 3 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 53 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Headache | 37 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 44 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Gastro. symp. | 16 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Fatigue | 8 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Temp. | 0 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Gastro. symp. | 1 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Gastro. symp. | 9 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Headache | 47 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Fatigue | 1 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Headache | 44 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Gastro. symp. | 19 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Headache | 33 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Temp. | 9 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Headache | 2 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 50 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Gastro. symp. | 14 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Gastro. symp. | 2 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 41 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Temp. | 8 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Temp. | 0 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Headache | 5 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 56 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Fatigue | 4 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 50 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Gastro. symp. | 23 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Gastro. symp. | 1 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Gastro. symp. | 21 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Headache | 53 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Headache | 39 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Any Temp. | 12 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | G3 Temp. | 0 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited General Symptoms | Related Temp. | 11 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Related Gastro. symp. | 17 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | G3 Gastro. symp. | 0 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 45 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Any Temp. | 7 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Any Gastro. symp. | 20 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 39 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Related Temp. | 6 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | G3 Temp. | 0 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | G3 Headache | 3 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Any Headache | 39 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | G3 Fatigue | 2 Participants |
| Boostrix Group | Number of Subjects With Solicited General Symptoms | Related Headache | 33 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 62 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 6 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 7 Participants |
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 68 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 3 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 6 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 9 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 8 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 12 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 104 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 5 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 104 Participants |
| Boostrix Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 6 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 30-Day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 35 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 38 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 34 Participants |
| Boostrix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 37 Participants |
Primary
Titres of RSV-A Neutralizing Antibodies
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
Time frame: At Day 0 pre-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 397.1 Titres |
| GSK3003891A 60 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 326.3 Titres |
| GSK3003891A 60 Adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 444.2 Titres |
| Boostrix Group | Titres of RSV-A Neutralizing Antibodies | 423.7 Titres |
Primary
Titres of RSV-A Neutralizing Antibodies
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
Time frame: At Day 30 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 1237.0 Titres |
| GSK3003891A 60 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 1278.7 Titres |
| GSK3003891A 60 Adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 1442.5 Titres |
| Boostrix Group | Titres of RSV-A Neutralizing Antibodies | 387.1 Titres |
Secondary
Concentrations of Palivizumab Competing Antibodies (PCA)
Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
Time frame: At Day 0 pre-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Concentrations of Palivizumab Competing Antibodies (PCA) | 5.4 µg/mL |
| GSK3003891A 60 Non-adjuvanted Group | Concentrations of Palivizumab Competing Antibodies (PCA) | 5.2 µg/mL |
| GSK3003891A 60 Adjuvanted Group | Concentrations of Palivizumab Competing Antibodies (PCA) | 4.6 µg/mL |
| Boostrix Group | Concentrations of Palivizumab Competing Antibodies (PCA) | 5.7 µg/mL |
Secondary
Concentrations of PCA
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
Time frame: At Day 30 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Concentrations of PCA | 79.9 µg/mL |
| GSK3003891A 60 Non-adjuvanted Group | Concentrations of PCA | 88.6 µg/mL |
| GSK3003891A 60 Adjuvanted Group | Concentrations of PCA | 97.2 µg/mL |
| Boostrix Group | Concentrations of PCA | 6.1 µg/mL |
Secondary
Concentrations of PCA
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
Time frame: At Day 90 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Concentrations of PCA | 60.4 µg/mL |
| GSK3003891A 60 Non-adjuvanted Group | Concentrations of PCA | 62.5 µg/mL |
| GSK3003891A 60 Adjuvanted Group | Concentrations of PCA | 66.1 µg/mL |
| Boostrix Group | Concentrations of PCA | 7.5 µg/mL |
Secondary
Concentrations of PCA
PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
Time frame: At Day 60 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Concentrations of PCA | 65.9 µg/mL |
| GSK3003891A 60 Non-adjuvanted Group | Concentrations of PCA | 68.4 µg/mL |
| GSK3003891A 60 Adjuvanted Group | Concentrations of PCA | 74.1 µg/mL |
| Boostrix Group | Concentrations of PCA | 5.8 µg/mL |
Secondary
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Up to study end at Day 360
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Number of Subjects With SAEs | 3 Participants |
| GSK3003891A 60 Non-adjuvanted Group | Number of Subjects With SAEs | 3 Participants |
| GSK3003891A 60 Adjuvanted Group | Number of Subjects With SAEs | 6 Participants |
| Boostrix Group | Number of Subjects With SAEs | 2 Participants |
Secondary
Titres of RSV-A Neutralizing Antibodies
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).
Time frame: At Day 60 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 947.2 Titres |
| GSK3003891A 60 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 882.9 Titres |
| GSK3003891A 60 Adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 1055.7 Titres |
| Boostrix Group | Titres of RSV-A Neutralizing Antibodies | 358.8 Titres |
Secondary
Titres of RSV-A Neutralizing Antibodies
RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).
Time frame: At Day 90 post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3003891A 30 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 837.7 Titres |
| GSK3003891A 60 Non-adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 774.5 Titres |
| GSK3003891A 60 Adjuvanted Group | Titres of RSV-A Neutralizing Antibodies | 897.5 Titres |
| Boostrix Group | Titres of RSV-A Neutralizing Antibodies | 358.3 Titres |