Group B Streptococcal Infections
Conditions
Brief summary
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.
Interventions
BIOLOGICALGroup B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
2 formulations at 1 dose level
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received.
Eligibility
Sex/Gender
ALL
Age
20 Years to 51 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. 2. Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.
Exclusion criteria
1. Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 3 months after the last dose of investigational product. 2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection. 3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine. 4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae). 5. Previous vaccination with any licensed or investigational group B streptococcus vaccine (other than GBS6), or planned receipt during the participant's participation in the study (through 6-month telephone call).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose | Within 6 months after booster dose | An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. |
| Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Within 14 days after booster dose | Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter \[cm\]), moderate (greater than \[\>\] 5.0-10.0 cm),severe (\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived. |
| Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Within 14 days after booster dose | Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or\>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:\>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever \>24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization. |
| Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose | Within 1 month after booster dose | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs. |
| Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose | Within 6 months after booster dose | An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Before and 1 month after booster dose | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Within 6 months after primary dose and within 1 month after booster dose | OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose. |
| GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | 1 month after booster dose | IgG for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose. |
| GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | 1 month after booster dose | OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose. |
| GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | 1 month after booster dose | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1. |
Countries
United States
Participant flow
Pre-assignment details
Overall, a total of 151 participants were assigned and vaccinated with a single booster dose of group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) (20 microgram \[μg\] capsular polysaccharide \[CPS\]/serotype/dose) formulated with or without aluminum phosphate (AlPO4) based on the formulation received in the primary C1091001 study.
Participants by arm
| Arm | Count |
|---|---|
| GBS6 20 μg With AlPO4 Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months. | 76 |
| GBS6 20 μg Without AlPO4 Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months. | 75 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | GBS6 20 μg Without AlPO4 | Total | GBS6 20 μg With AlPO4 |
|---|---|---|---|
| Age, Continuous | 36.2 Years STANDARD_DEVIATION 8.96 | 36.7 Years STANDARD_DEVIATION 8.67 | 37.1 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 141 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 20 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 125 Participants | 66 Participants |
| Sex: Female, Male Female | 60 Participants | 114 Participants | 54 Participants |
| Sex: Female, Male Male | 15 Participants | 37 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 |
| other Total, other adverse events | 59 / 76 | 54 / 75 |
| serious Total, serious adverse events | 1 / 76 | 0 / 75 |
Outcome results
Primary
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.
Time frame: Within 1 month after booster dose
Population: Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose | 6.6 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose | 12.0 percentage of participants |
Primary
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Time frame: Within 6 months after booster dose
Population: Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose | 11.8 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose | 9.3 percentage of participants |
Primary
Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site)
Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter \[cm\]), moderate (greater than \[\>\] 5.0-10.0 cm),severe (\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.
Time frame: Within 14 days after booster dose
Population: All the participants reporting yes or no for at least 1 day were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Moderate | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Mild | 53.9 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Moderate | 11.8 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Mild | 3.9 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Moderate | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Severe | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Any | 2.6 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Mild | 2.6 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Severe | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Severe | 2.6 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Any | 3.9 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Any | 68.4 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Any | 4.0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Any | 42.7 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Severe | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Mild | 38.7 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Mild | 2.7 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Severe | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Any | 2.7 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Moderate | 4.0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Moderate | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Severe | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Redness: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Mild | 4.0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Pain at injection site: Grade 4 | 0 Percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site) | Swelling: Moderate | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain)
Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or\>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:\>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever \>24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization.
Time frame: Within 14 days after booster dose
Population: All the participants reporting yes or no for at least 1 day were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Any | 23.7 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Mild | 11.8 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Any | 7.9 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Moderate | 9.2 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Severe | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Severe | 2.6 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Grade 4 | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Mild | 6.6 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >38.4°C to 38.9°C | 2.6 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Any | 30.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Severe | 1.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Mild | 21.1 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Moderate | 9.2 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Mild | 6.6 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: 38.0°C to 38.4°C | 1.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Severe | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Severe | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Moderate | 1.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Any | 44.7 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >40.0°C | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Moderate | 1.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Mild | 23.7 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Grade 4 | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Grade 4 | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Moderate | 19.7 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Grade 4 | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever:>=38.0 degree C | 3.9 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Severe | 1.3 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >38.9°C to 40.0°C | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Any | 15.8 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Grade 4 | 0 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Any | 11.8 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Mild | 14.5 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Moderate | 3.9 percentage of participants |
| GBS6 20 μg With AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: 38.0°C to 38.4°C | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >38.4°C to 38.9°C | 1.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >38.9°C to 40.0°C | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever: >40.0°C | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Any | 10.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Moderate | 5.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Moderate | 5.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Moderate | 13.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Severe | 1.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Any | 30.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Mild | 20.0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Moderate | 9.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Severe | 1.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fatigue/tiredness: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Mild | 14.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Moderate | 2.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Mild | 6.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Moderate | 2.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Severe | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Fever:>=38.0 degree C | 1.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Mild | 5.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Nausea/vomiting: Severe | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Any | 16.0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Mild | 10.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Diarrhea: Severe | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Any | 41.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Headache: Mild | 26.7 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Any | 17.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Severe | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Muscle pain: Grade 4 | 0 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain) | Joint pain: Any | 9.3 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Time frame: Within 6 months after booster dose
Population: Safety population included all participants who received the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS6 20 μg With AlPO4 | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose | 1.3 percentage of participants |
| GBS6 20 μg Without AlPO4 | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose | 0 percentage of participants |
Secondary
GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: Before and 1 month after booster dose
Population: Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ia: Day 1 - Booster Dose | 3.070 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 47.600 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ib: Day 1 - Booster Dose | 0.537 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 24.298 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | II: Day 1 - Booster Dose | 5.244 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | II: Month 1 - Booster Dose | 51.670 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | III: Day 1 - Booster Dose | 0.850 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | III: Month 1 - Booster Dose | 13.511 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | IV: Day 1 - Booster Dose | 0.768 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 30.048 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | V: Day 1 - Booster Dose | 1.104 Microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | V: Month 1 - Booster Dose | 39.368 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 33.216 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ia: Day 1 - Booster Dose | 3.252 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | III: Day 1 - Booster Dose | 1.227 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 52.038 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | III: Month 1 - Booster Dose | 17.305 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ib: Day 1 - Booster Dose | 0.588 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | V: Day 1 - Booster Dose | 0.992 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 20.095 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | IV: Day 1 - Booster Dose | 0.873 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | II: Day 1 - Booster Dose | 6.379 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | V: Month 1 - Booster Dose | 52.326 Microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose | II: Month 1 - Booster Dose | 64.617 Microgram per milliliter |
Secondary
GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose
IgG for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.
Time frame: 1 month after booster dose
Population: Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 15.504 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 45.282 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | II: Month 1 - Booster Dose | 9.853 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | III: Month 1 - Booster Dose | 15.889 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 39.133 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | V: Month 1 - Booster Dose | 35.668 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 38.063 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 16.003 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | III: Month 1 - Booster Dose | 14.100 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 34.191 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | V: Month 1 - Booster Dose | 52.750 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose | II: Month 1 - Booster Dose | 10.130 Fold rise |
Secondary
GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose)
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1.
Time frame: 1 month after booster dose
Population: Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ia: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 55.766 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | II: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 45.285 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | III: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 13.228 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | III: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 22.612 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ib: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 23.624 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | IV: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 48.545 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ia: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 47.396 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | IV: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 29.661 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | V: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 96.017 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | II: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 189.611 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | V: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 37.465 microgram per milliliter |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ib: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 40.327 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | V: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 51.842 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | III: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 18.368 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | IV: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 32.046 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ia: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 148.088 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ia: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 45.843 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ib: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 112.434 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | Ib: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 19.156 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | II: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 52.439 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | II: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 66.513 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | III: Month 1 - Booster Dose Month 1 - Booster Dose = Negative | 17.214 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | IV: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 77.627 microgram per milliliter |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose) | V: Month 1 - Booster Dose Month 1 - Booster Dose = Positive | 103.130 microgram per milliliter |
Secondary
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.
Time frame: 1 month after booster dose
Population: Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 6.9 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 9.1 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | II: Month 1 - Booster Dose | 4.8 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | III: Month 1 - Booster Dose | 4.8 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 4.1 Fold rise |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | V: Month 1 - Booster Dose | 4.7 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 4.3 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 6.5 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | III: Month 1 - Booster Dose | 5.2 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 6.4 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | V: Month 1 - Booster Dose | 3.8 Fold rise |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose | II: Month 1 - Booster Dose | 4.2 Fold rise |
Secondary
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.
Time frame: Within 6 months after primary dose and within 1 month after booster dose
Population: Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ia: Day 1 - Booster Dose | 1368 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 9374 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ib: Day 1 - Booster Dose | 3307 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 28809 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | II: Day 1 - Booster Dose | 3209 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | II: Month 1 - Booster Dose | 16057 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | III: Day 1 - Booster Dose | 756 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | III: Month 1 - Booster Dose | 3695 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | IV: Day 1 - Booster Dose | 5591 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 22994 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | V: Day 1 - Booster Dose | 2249 Titer |
| GBS6 20 μg With AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | V: Month 1 - Booster Dose | 10484 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | V: Day 1 - Booster Dose | 2324 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ia: Day 1 - Booster Dose | 1361 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | III: Day 1 - Booster Dose | 641 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ia: Month 1 - Booster Dose | 8809 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | IV: Month 1 - Booster Dose | 19710 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ib: Day 1 - Booster Dose | 2734 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | III: Month 1 - Booster Dose | 3339 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | Ib: Month 1 - Booster Dose | 18550 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | V: Month 1 - Booster Dose | 8802 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | II: Day 1 - Booster Dose | 3659 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | IV: Day 1 - Booster Dose | 4617 Titer |
| GBS6 20 μg Without AlPO4 | GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose | II: Month 1 - Booster Dose | 15317 Titer |