Trial Outcomes & Findings for A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS (NCT NCT04258995)
NCT ID: NCT04258995
Last Updated: 2021-10-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Within 14 days after booster dose
Results posted on
2021-10-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
75
|
|
Overall Study
Vaccinated
|
76
|
75
|
|
Overall Study
COMPLETED
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
Baseline characteristics by cohort
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 Years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
36.7 Years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 14 days after booster dosePopulation: All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
|---|---|---|
|
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
Interval 56.7 to 78.6
|
42.7 Percentage of participants
Interval 31.3 to 54.6
|
|
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
Interval 42.1 to 65.5
|
38.7 Percentage of participants
Interval 27.6 to 50.6
|
|
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
Interval 5.6 to 21.3
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.3 to 9.2
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.8 to 11.1
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
|
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
Interval 0.8 to 11.1
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.3 to 9.2
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
|
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
Interval 0.3 to 9.2
|
4.0 Percentage of participants
Interval 0.8 to 11.2
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 Percentage of participants
Interval 0.0 to 4.8
|
PRIMARY outcome
Timeframe: Within 14 days after booster dosePopulation: All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
|---|---|---|
|
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
Interval 0.8 to 11.1
|
1.3 percentage of participants
Interval 0.0 to 7.2
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 7.1
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.3 to 9.2
|
1.3 percentage of participants
Interval 0.0 to 7.2
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 3.0 to 16.4
|
10.7 percentage of participants
Interval 4.7 to 19.9
|
|
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
Interval 2.2 to 14.7
|
5.3 percentage of participants
Interval 1.5 to 13.1
|
|
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
Interval 0.0 to 7.1
|
5.3 percentage of participants
Interval 1.5 to 13.1
|
|
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
Interval 8.4 to 26.0
|
16.0 percentage of participants
Interval 8.6 to 26.3
|
|
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
Interval 7.5 to 24.4
|
10.7 percentage of participants
Interval 4.7 to 19.9
|
|
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
Interval 0.0 to 7.1
|
5.3 percentage of participants
Interval 1.5 to 13.1
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 20.2 to 41.9
|
41.3 percentage of participants
Interval 30.1 to 53.3
|
|
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
Interval 12.5 to 31.9
|
26.7 percentage of participants
Interval 17.1 to 38.1
|
|
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
Interval 3.8 to 18.1
|
13.3 percentage of participants
Interval 6.6 to 23.2
|
|
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
Interval 0.0 to 4.7
|
1.3 percentage of participants
Interval 0.0 to 7.2
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 33.3 to 56.6
|
30.7 percentage of participants
Interval 20.5 to 42.4
|
|
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
Interval 14.7 to 34.8
|
20.0 percentage of participants
Interval 11.6 to 30.8
|
|
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
Interval 11.5 to 30.5
|
9.3 percentage of participants
Interval 3.8 to 18.3
|
|
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
Interval 0.0 to 7.1
|
1.3 percentage of participants
Interval 0.0 to 7.2
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 14.7 to 34.8
|
17.3 percentage of participants
Interval 9.6 to 27.8
|
|
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
Interval 5.6 to 21.3
|
14.7 percentage of participants
Interval 7.6 to 24.7
|
|
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
Interval 3.8 to 18.1
|
2.7 percentage of participants
Interval 0.3 to 9.3
|
|
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
Interval 0.3 to 9.2
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 5.6 to 21.3
|
9.3 percentage of participants
Interval 3.8 to 18.3
|
|
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
Interval 2.2 to 14.7
|
6.7 percentage of participants
Interval 2.2 to 14.9
|
|
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
Interval 0.8 to 11.1
|
2.7 percentage of participants
Interval 0.3 to 9.3
|
|
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
Interval 0.0 to 7.1
|
0 percentage of participants
Interval 0.0 to 4.8
|
|
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
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 4.8
|
PRIMARY outcome
Timeframe: Within 1 month after booster dosePopulation: Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the 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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
|---|---|---|
|
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose
|
6.6 percentage of participants
Interval 2.2 to 14.7
|
12.0 percentage of participants
Interval 5.6 to 21.6
|
PRIMARY outcome
Timeframe: Within 6 months after booster dosePopulation: Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the 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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
|---|---|---|
|
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose
|
11.8 percentage of participants
Interval 5.6 to 21.3
|
9.3 percentage of participants
Interval 3.8 to 18.3
|
PRIMARY outcome
Timeframe: Within 6 months after booster dosePopulation: Safety population included all participants who received the 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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=75 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose
|
1.3 percentage of participants
Interval 0.0 to 7.1
|
0 percentage of participants
Interval 0.0 to 4.8
|
SECONDARY outcome
Timeframe: Before and 1 month after booster dosePopulation: 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.
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=74 Participants
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.
|
|---|---|---|
|
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
Interval 23.259 to 38.818
|
33.216 Microgram per milliliter
Interval 24.452 to 45.12
|
|
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
Interval 0.608 to 2.004
|
0.992 Microgram per milliliter
Interval 0.556 to 1.771
|
|
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
Interval 1.539 to 6.125
|
3.252 Microgram per milliliter
Interval 1.558 to 6.787
|
|
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
Interval 34.705 to 65.285
|
52.038 Microgram per milliliter
Interval 35.654 to 75.951
|
|
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
Interval 0.272 to 1.06
|
0.588 Microgram per milliliter
Interval 0.302 to 1.146
|
|
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
Interval 17.396 to 33.94
|
20.095 Microgram per milliliter
Interval 14.033 to 28.775
|
|
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
Interval 3.186 to 8.63
|
6.379 Microgram per milliliter
Interval 4.007 to 10.155
|
|
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
Interval 39.31 to 67.916
|
64.617 Microgram per milliliter
Interval 47.313 to 88.249
|
|
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
Interval 0.508 to 1.423
|
1.227 Microgram per milliliter
Interval 0.75 to 2.008
|
|
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
Interval 10.224 to 17.854
|
17.305 Microgram per milliliter
Interval 12.994 to 23.046
|
|
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
Interval 0.496 to 1.189
|
0.873 Microgram per milliliter
Interval 0.573 to 1.329
|
|
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
Interval 27.387 to 56.589
|
52.326 Microgram per milliliter
Interval 36.887 to 74.227
|
SECONDARY outcome
Timeframe: Within 6 months after primary dose and within 1 month after booster dosePopulation: 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.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=74 Participants
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.
|
|---|---|---|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
Ia: Day 1 - Booster Dose
|
1368 Titer
Interval 826.0 to 2266.0
|
1361 Titer
Interval 831.0 to 2228.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
Ia: Month 1 - Booster Dose
|
9374 Titer
Interval 7164.0 to 12266.0
|
8809 Titer
Interval 6665.0 to 11643.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
Ib: Day 1 - Booster Dose
|
3307 Titer
Interval 1993.0 to 5487.0
|
2734 Titer
Interval 1603.0 to 4662.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
Ib: Month 1 - Booster Dose
|
28809 Titer
Interval 21345.0 to 38883.0
|
18550 Titer
Interval 12943.0 to 26586.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
II: Day 1 - Booster Dose
|
3209 Titer
Interval 2266.0 to 4545.0
|
3659 Titer
Interval 2705.0 to 4950.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
II: Month 1 - Booster Dose
|
16057 Titer
Interval 12486.0 to 20650.0
|
15317 Titer
Interval 11689.0 to 20071.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
III: Day 1 - Booster Dose
|
756 Titer
Interval 508.0 to 1126.0
|
641 Titer
Interval 432.0 to 951.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
III: Month 1 - Booster Dose
|
3695 Titer
Interval 2776.0 to 4917.0
|
3339 Titer
Interval 2381.0 to 4681.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
IV: Day 1 - Booster Dose
|
5591 Titer
Interval 4295.0 to 7279.0
|
4617 Titer
Interval 3429.0 to 6217.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
IV: Month 1 - Booster Dose
|
22994 Titer
Interval 18192.0 to 29063.0
|
19710 Titer
Interval 15517.0 to 25035.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
V: Day 1 - Booster Dose
|
2249 Titer
Interval 1498.0 to 3376.0
|
2324 Titer
Interval 1517.0 to 3560.0
|
|
GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose
V: Month 1 - Booster Dose
|
10484 Titer
Interval 7993.0 to 13750.0
|
8802 Titer
Interval 6417.0 to 12073.0
|
SECONDARY outcome
Timeframe: 1 month after booster dosePopulation: 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.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=74 Participants
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.
|
|---|---|---|
|
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
Interval 9.452 to 25.43
|
16.003 Fold rise
Interval 9.8 to 26.132
|
|
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
Interval 27.919 to 73.441
|
34.191 Fold rise
Interval 21.272 to 54.955
|
|
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
Interval 6.783 to 14.313
|
10.130 Fold rise
Interval 6.822 to 15.042
|
|
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
Interval 10.138 to 24.902
|
14.100 Fold rise
Interval 9.453 to 21.031
|
|
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
Interval 26.569 to 57.638
|
38.063 Fold rise
Interval 26.189 to 55.321
|
|
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
Interval 23.796 to 53.463
|
52.750 Fold rise
Interval 34.308 to 81.107
|
SECONDARY outcome
Timeframe: 1 month after booster dosePopulation: 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.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=74 Participants
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.
|
|---|---|---|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
Ia: Month 1 - Booster Dose
|
6.9 Fold rise
Interval 4.8 to 10.0
|
6.5 Fold rise
Interval 4.43 to 9.45
|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
Ib: Month 1 - Booster Dose
|
9.1 Fold rise
Interval 6.21 to 13.47
|
6.4 Fold rise
Interval 4.46 to 9.3
|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
II: Month 1 - Booster Dose
|
4.8 Fold rise
Interval 3.65 to 6.36
|
4.2 Fold rise
Interval 3.08 to 5.68
|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
III: Month 1 - Booster Dose
|
4.8 Fold rise
Interval 3.54 to 6.58
|
5.2 Fold rise
Interval 3.79 to 7.15
|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
IV: Month 1 - Booster Dose
|
4.1 Fold rise
Interval 3.18 to 5.32
|
4.3 Fold rise
Interval 3.17 to 5.74
|
|
GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose
V: Month 1 - Booster Dose
|
4.7 Fold rise
Interval 3.27 to 6.65
|
3.8 Fold rise
Interval 2.63 to 5.45
|
SECONDARY outcome
Timeframe: 1 month after booster dosePopulation: 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.
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.
Outcome measures
| Measure |
GBS6 20 μg With AlPO4
n=76 Participants
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.
|
GBS6 20 μg Without AlPO4
n=74 Participants
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.
|
|---|---|---|
|
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
Interval 0.0 to 30690052.3
|
148.088 microgram per milliliter
Interval 50.544 to 433.884
|
|
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
Interval 34.343 to 65.412
|
45.843 microgram per milliliter
Interval 30.695 to 68.465
|
|
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
Interval 3.968 to 409.881
|
112.434 microgram per milliliter
Interval 0.0 to 245914635.435
|
|
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
Interval 16.732 to 33.353
|
19.156 microgram per milliliter
Interval 13.365 to 27.456
|
|
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
Interval 105.577 to 340.534
|
52.439 microgram per milliliter
Interval 18.337 to 149.961
|
|
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
Interval 34.25 to 59.876
|
66.513 microgram per milliliter
Interval 47.596 to 92.948
|
|
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
Interval 4.268 to 119.786
|
18.368 microgram per milliliter
Interval 6.559 to 51.438
|
|
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
Interval 9.915 to 17.647
|
17.214 microgram per milliliter
Interval 12.681 to 23.366
|
|
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
Interval 0.0 to 347896565796.0
|
77.627 microgram per milliliter
Interval 22.933 to 262.759
|
|
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
Interval 23.021 to 38.216
|
32.046 microgram per milliliter
Interval 23.36 to 43.96
|
|
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
Interval 19.528 to 472.109
|
103.130 microgram per milliliter
|
|
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
Interval 25.698 to 54.622
|
51.842 microgram per milliliter
Interval 36.385 to 73.865
|
Adverse Events
GBS6 20 μg With AlPO4
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
GBS6 20 μg Without AlPO4
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GBS6 20 μg With AlPO4
n=76 participants at risk
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.
|
GBS6 20 μg Without AlPO4
n=75 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.3%
1/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
0.00%
0/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
Other adverse events
| Measure |
GBS6 20 μg With AlPO4
n=76 participants at risk
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.
|
GBS6 20 μg Without AlPO4
n=75 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
12/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
16.0%
12/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
6/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
10.7%
8/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
General disorders
Fatigue
|
44.7%
34/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
30.7%
23/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
General disorders
Injection site pain
|
68.4%
52/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
42.7%
32/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
9/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
9.3%
7/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.7%
18/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
17.3%
13/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
|
Nervous system disorders
Headache
|
30.3%
23/76 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
41.3%
31/75 • The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).
Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER