Meningococcal Infection
Conditions
Brief summary
This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.
Detailed description
This study is to assess the longevity of immune responses in adolescents (aged 10 to \<19 years at the time of entry into a primary study) following receipt of a vaccination regimen of 2 or 3 doses of bivalent rLP2086 in a primary study. A booster dose of bivalent rLP2086 at approximately 48 months was given following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series. The study was therefore divided into Stage 1 (4-year persistence of immune responses following receipt of a primary vaccination series) and the booster stage (follow-up through 12 months for all boosted or 26 months for a subset of the boosted). Subjects participating only in Stage 1 will attend up to 6 study visits for collection of a 20-mL blood sample at each visit. Subjects participating in both Stage 1 and booster stage will attend up to 9-10 study visits with 1 visit for booster dose vaccination and 8-9 visits for collection of a 20-mL blood sample at each visit.
Interventions
PROCEDUREblood sampling
Blood sample collection at different time points
DRUGbivalent rLP2086
A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.
Sponsors
Pfizer
Study design
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
for Stage 1: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures. 3. Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for study B1971033. 4. Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study. Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up): 1. Evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study. 2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1
Exclusion criteria
. 3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study. 4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw. 5. Subject is available for the entire period of the booster stage and the subject or subject's parent(s)/legal guardian can be reached by telephone. 6. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception through Visit 10 of the booster stage. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Section 4.5 for further information. 8. Negative urine pregnancy test for all female subjects on the day of the booster dose. Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up): 1. For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11. 2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | Month 6 (Visit 1 of study B1971033) | For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at Month 12 (Visit 2). Hence, no participants enrolled from primary study B1971012 had serology results at Month 6. |
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | Month 12 (Visit 2 of study B1971033) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). |
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | Month 18 (Visit 3 of study B1971033) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). |
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | Month 24 (Visit 4 of study B1971033) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). |
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | Month 36 (Visit 5 of study B1971033) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). |
| Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | Month 48 (Visit 6 of study B1971033) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). |
| Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | 1 month after last vaccination in primary study | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. |
| Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | Visit 6 of study B1971033 (48 months after last vaccination in primary study) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. |
| Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | Visit 8 (1 month following the booster vaccination on Month 49) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. |
| Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | Visit 10 (12 months following the booster vaccination on Month 60) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. |
| Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | Visit 11 (26 months following the booster vaccination on Month 74) | For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. only participants who received bivalent rLP2086 in primary study B1971010 were not analysed for this endpoint. Only participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be followed for 26 months after booster vaccination |
| Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Within 7 days after booster vaccination on Month 48 | Local reactions were collected by using an e-diary and included pain at injection site, redness and swelling. Redness and swelling were graded as: none (0-2.0 centimetre \[cm\]), mild (2.5-5.0 cm), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm). Pain was graded as: mild (does not interfere with activity), moderate (Interferes with activity) and severe (prevents daily activity). |
| Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Within 7 days after booster vaccination on Month 48 | Systemic reactions included: fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site and joint pain, all other systemic reactions were recorded by using an e-diary. Fever was categorized as: 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \> 40.0 degree C. Vomiting was graded as: mild (1 to 2 times in 24 hours \[hrs\]), moderate (\>2 times in 24 hrs) and severe (requires intravenous \[IV\] hydration); Diarrhea was graded as: mild (2 to 3 loose stools in 24 hrs), moderate (4 to 5 loose stools in 24 hrs) and severe (6 or more loose stools in 24 hrs); Headache, fatigue, chills, muscle pain and joint pain was graded as: mild (does not interfere with daily activities), moderate (some interference with activity) and severe (prevents daily routine activity). |
| Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage | An AE was any untoward medical occurrence 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. AEs included both non-serious AEs and serious adverse events (SAEs). An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility. |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage | An AE was any untoward medical occurrence 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. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility. |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54) | 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. An MAE was defined as a nonserious AE (AE other than SAE) that resulted in an evaluation at a medical facility. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | Visit 1 of B1971033 (6-month safety telephone call after last dose in primary study) to Visit 6 of B1971033 (6 months after last primary dose to 48 months after last primary dose in primary study) | An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60) | An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60) | An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11) | From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74) | An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11) | From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74) | An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination. |
| Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | Within 30 minutes after Booster Vaccination in Month 48 | Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
| Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of days participants missed work or school due to AE occurred following booster vaccination were reported here. |
Countries
Czechia, Denmark, Finland, Germany, Sweden, United States
Participant flow
Recruitment details
Total 698 participants enrolled in this extension study, who were enrolled in any 1 of the primary studies B1971010 (NCT01323270), B1971012 (NCT01299480), and B1971015 (NCT01461980).
Pre-assignment details
This study consisted of 2 stages: Stage 1 and Booster stage. Only participants from primary studies B1971010 and B1971012 who received bivalent rLP2086 in the primary study and completed Stage 1 in this study, were eligible to participate in the booster stage.
Participants by arm
| Arm | Count |
|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study. | 70 |
| Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033. | 103 |
| Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033. | 277 |
| Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033. | 116 |
| Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033. | 86 |
| Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033. | 46 |
| Total | 698 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Booster Stage (26 Months) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Booster Stage (26 Months) | Withdrawal before booster vaccination | 0 | 1 | 0 | 0 | 2 | 0 |
| Stage 1 (48 Months) | Lost to Follow-up | 3 | 4 | 12 | 0 | 0 | 0 |
| Stage 1 (48 Months) | No longer met eligibility criteria | 1 | 0 | 1 | 2 | 0 | 0 |
| Stage 1 (48 Months) | No longer willing to participate | 5 | 3 | 18 | 6 | 3 | 0 |
| Stage 1 (48 Months) | Other than specified | 5 | 0 | 9 | 0 | 0 | 0 |
| Stage 1 (48 Months) | Protocol Violation | 0 | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Group 6: rLP2086 (0- and 4-Month Schedule) | Group 5: rLP2086 (0- and 2-Month Schedule) | Group 4: rLP2086 (0-and 6-Month Schedule) | Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) | Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) | Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.8 years STANDARD_DEVIATION 2.7 | 15.9 years STANDARD_DEVIATION 2.1 | 16.1 years STANDARD_DEVIATION 2.4 | 15.8 years STANDARD_DEVIATION 2.1 | 14.3 years STANDARD_DEVIATION 2.8 | 15.9 years STANDARD_DEVIATION 2.2 | 11.7 years STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 0 Participants | 2 Participants | 1 Participants | 25 Participants | 0 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 654 Participants | 46 Participants | 84 Participants | 115 Participants | 252 Participants | 103 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 22 Participants | 0 Participants | 0 Participants | 1 Participants | 12 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 0 Participants | 1 Participants | 0 Participants | 8 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 664 Participants | 46 Participants | 85 Participants | 115 Participants | 256 Participants | 103 Participants | 59 Participants |
| Sex: Female, Male Female | 362 Participants | 26 Participants | 38 Participants | 67 Participants | 144 Participants | 55 Participants | 32 Participants |
| Sex: Female, Male Male | 336 Participants | 20 Participants | 48 Participants | 49 Participants | 133 Participants | 48 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 101 | 0 / 277 | 0 / 116 | 0 / 86 | 0 / 46 | 0 / 59 | 0 / 92 | 0 / 64 | 0 / 54 | 0 / 32 |
| other Total, other adverse events | 4 / 70 | 0 / 101 | 1 / 277 | 0 / 116 | 2 / 86 | 1 / 46 | 56 / 59 | 90 / 92 | 62 / 64 | 53 / 54 | 31 / 32 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 1 / 59 | 1 / 92 | 2 / 64 | 1 / 54 | 0 / 32 |
Outcome results
Primary
Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of days participants missed work or school due to AE occurred following booster vaccination were reported here.
Time frame: From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, Overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | 17.5 days | Standard Deviation 28.14 |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | 12.4 days | Standard Deviation 9.72 |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | 10.1 days | Standard Deviation 9.14 |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | 3.0 days | Standard Deviation 2.65 |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9) | 4.8 days | Standard Deviation 2.56 |
Primary
Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.
Time frame: 1 month after last vaccination in primary study
Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid,determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinate hSBA titers for given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 100.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 88.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 86.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 89.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 96.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 100.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 93.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 91.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 91.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 98.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 89.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 98.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 81.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 98.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 85.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 71.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 77.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 73.1 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2707 (B44) | 87.5 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2948 (B24) | 79.3 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB2001 (A56) | 96.9 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study | PMB80 (A22) | 84.4 percentage of participants |
Primary
Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6])
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.
Time frame: Visit 6 of study B1971033 (48 months after last vaccination in primary study)
Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 49.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 43.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 40.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 36.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 46.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 41.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 48.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 33.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 35.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 49.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 56.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 56.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 55.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 12.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 43.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 40.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 46.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 37.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 51.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 57.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2001 (A56) | 43.3 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2948 (B24) | 45.2 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB2707 (B44) | 34.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) | PMB80 (A22) | 48.4 percentage of participants |
Primary
Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10)
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.
Time frame: Visit 10 (12 months following the booster vaccination on Month 60)
Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 74.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 90.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 65.5 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 75.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 66.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 87.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 89.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 76.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 81.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 74.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 89.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 77.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 80.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 59.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 81.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 77.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 65.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 78.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 74.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 82.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2948 (B24) | 84.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB2707 (B44) | 93.3 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) | PMB80 (A22) | 96.8 percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8)
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.
Time frame: Visit 8 (1 month following the booster vaccination on Month 49)
Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 100.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 100.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 100.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 96.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 96.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 100.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 96.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 93.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 98.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 96.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 94.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 98.1 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2001 (A56) | 100.0 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2948 (B24) | 100.0 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB2707 (B44) | 100.0 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) | PMB80 (A22) | 100.0 percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11)
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. only participants who received bivalent rLP2086 in primary study B1971010 were not analysed for this endpoint. Only participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be followed for 26 months after booster vaccination
Time frame: Visit 11 (26 months following the booster vaccination on Month 74)
Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB80 (A22) | 73.5 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2001 (A56) | 82.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2948 (B24) | 78.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2707 (B44) | 66.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2707 (B44) | 62.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB80 (A22) | 61.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2948 (B24) | 59.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) | PMB2001 (A56) | 57.5 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Time frame: Month 12 (Visit 2 of study B1971033)
Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 29.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 17.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 1.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 1.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 24.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 73.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 41.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 40.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 69.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 47.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 66.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 37.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 45.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 76.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 49.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 22.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 32.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 24.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 63.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 61.5 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 16.5 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 36.9 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 60.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 36.3 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 21.2 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 44.0 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 41.5 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 69.0 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2001 (A56) | 71.4 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2948 (B24) | 37.0 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB2707 (B44) | 22.2 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations | PMB80 (A22) | 41.3 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Time frame: Month 18 (Visit 3 of study B1971033)
Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 23.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 11.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 5.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 26.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 64.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 37.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 45.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 57.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 31.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 56.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 39.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 44.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 72.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 46.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 18.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 29.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 23.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 53.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 51.3 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 15.9 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 31.4 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 57.8 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 47.7 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 24.4 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 47.1 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 39.5 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 62.7 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2001 (A56) | 62.8 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2948 (B24) | 50.0 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB2707 (B44) | 28.3 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations | PMB80 (A22) | 51.1 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Time frame: Month 24 (Visit 4 of study B1971033)
Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 17.6 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 3.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 4.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 3.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 23.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 69.2 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 34.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 43.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 50.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 38.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 57.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 39.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 40.2 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 68.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 43.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 18.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 27.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 25.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 36.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 49.6 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 15.7 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 31.8 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 53.8 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 42.2 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 22.9 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 44.0 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 37.3 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 58.8 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2001 (A56) | 60.0 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2948 (B24) | 51.1 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB2707 (B44) | 28.3 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations | PMB80 (A22) | 39.1 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Time frame: Month 36 (Visit 5 of study B1971033)
Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 27.6 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 7.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 3.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 1.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 21.6 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 58.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 41.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 41.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 60.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 33.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 54.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 38.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 39.2 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 67.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 42.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 16.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 24.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 30.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 35.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 49.5 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 20.2 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 33.6 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 58.6 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 42.6 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 21.7 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 42.7 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 48.1 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 59.3 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2001 (A56) | 50.0 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2948 (B24) | 41.9 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB2707 (B44) | 18.2 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations | PMB80 (A22) | 34.1 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations
For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Time frame: Month 48 (Visit 6 of study B1971033)
Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 16.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 2.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 7.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 3.6 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 20.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 47.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 41.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 41.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 51.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 41.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 42.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 50.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 43.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 58.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 40.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 18.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 23.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 23.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 30.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 34.7 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 18.9 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 30.5 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 57.6 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 39.6 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 24.4 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 45.7 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 45.1 percentage of participants |
| Group 5: rLP2086 (0- and 2-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 61.3 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2001 (A56) | 47.8 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2948 (B24) | 42.2 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB2707 (B44) | 23.9 percentage of participants |
| Group 6: rLP2086 (0- and 4-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations | PMB80 (A22) | 41.3 percentage of participants |
Primary
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations
For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at Month 12 (Visit 2). Hence, no participants enrolled from primary study B1971012 had serology results at Month 6.
Time frame: Month 6 (Visit 1 of study B1971033)
Population: Modified intent-to-treat (mITT) population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB80 (A22) | 14.3 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2001 (A56) | 16.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2948 (B24) | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2707 (B44) | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2707 (B44) | 64.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB80 (A22) | 86.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2948 (B24) | 36.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2001 (A56) | 72.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2707 (B44) | 56.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2001 (A56) | 88.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB2948 (B24) | 35.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations | PMB80 (A22) | 83.3 percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination
Local reactions were collected by using an e-diary and included pain at injection site, redness and swelling. Redness and swelling were graded as: none (0-2.0 centimetre \[cm\]), mild (2.5-5.0 cm), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm). Pain was graded as: mild (does not interfere with activity), moderate (Interferes with activity) and severe (prevents daily activity).
Time frame: Within 7 days after booster vaccination on Month 48
Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Any | 91.5 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Mild | 6.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Severe | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Moderate | 11.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Moderate | 6.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Moderate | 40.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Mild | 11.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Severe | 13.6 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Any | 18.6 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Any | 20.3 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Mild | 37.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Any | 20.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Mild | 8.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Mild | 5.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Mild | 29.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Any | 20.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Moderate | 10.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Severe | 4.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Any | 93.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Moderate | 10.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Severe | 9.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Severe | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Moderate | 54.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Severe | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Any | 89.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Mild | 28.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Moderate | 51.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Severe | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Any | 20.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Mild | 10.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Moderate | 7.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Any | 17.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Mild | 10.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Moderate | 6.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Severe | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Mild | 5.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Any | 27.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Severe | 5.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Severe | 9.3 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Any | 88.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Any | 14.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Moderate | 44.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Severe | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Mild | 3.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Mild | 35.2 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Moderate | 11.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Moderate | 16.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Any | 84.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Mild | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Mild | 25.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Severe | 12.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Any | 6.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Moderate | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Any | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Pain at injection site:Moderate | 46.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Swelling:Moderate | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination | Redness:Mild | 3.1 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination
Systemic reactions included: fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site and joint pain, all other systemic reactions were recorded by using an e-diary. Fever was categorized as: 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \> 40.0 degree C. Vomiting was graded as: mild (1 to 2 times in 24 hours \[hrs\]), moderate (\>2 times in 24 hrs) and severe (requires intravenous \[IV\] hydration); Diarrhea was graded as: mild (2 to 3 loose stools in 24 hrs), moderate (4 to 5 loose stools in 24 hrs) and severe (6 or more loose stools in 24 hrs); Headache, fatigue, chills, muscle pain and joint pain was graded as: mild (does not interfere with daily activities), moderate (some interference with activity) and severe (prevents daily routine activity).
Time frame: Within 7 days after booster vaccination on Month 48
Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Any | 50.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Moderate | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Mild | 8.5 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Moderate | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Mild | 8.5 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Any | 11.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Any | 10.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.5 to <39.0 degrees C | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Moderate | 5.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain: Mild | 16.9 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Any | 22.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 39.0 to 40.0 degrees C | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Moderate | 3.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Moderate | 10.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Mild | 13.6 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >40.0 degrees C | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >=38 degrees C | 5.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Any | 23.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Severe | 3.4 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Moderate | 32.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Any | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.0 to <38.5 degrees C | 5.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Mild | 27.1 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Any | 62.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Severe | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Mild | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Use of antipyretic medication | 10.2 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Moderate | 20.3 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Mild | 30.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >40.0 degrees C | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >=38 degrees C | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.0 to <38.5 degrees C | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.5 to <39.0 degrees C | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 39.0 to 40.0 degrees C | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Any | 3.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Mild | 3.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Moderate | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Severe | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Any | 13.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Mild | 12.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Moderate | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Severe | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Any | 47.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Mild | 28.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Moderate | 18.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Severe | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Any | 60.9 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Mild | 27.2 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Moderate | 31.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Severe | 2.2 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Any | 31.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Mild | 20.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Moderate | 9.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Severe | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Any | 29.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain: Mild | 15.2 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Moderate | 13.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Severe | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Any | 16.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Mild | 9.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Moderate | 6.5 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Severe | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Use of antipyretic medication | 14.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Severe | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Moderate | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain: Mild | 7.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >40.0 degrees C | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Moderate | 4.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Any | 20.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Any | 14.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Severe | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Any | 18.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Mild | 7.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Mild | 12.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Mild | 35.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 39.0 to 40.0 degrees C | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Moderate | 7.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Mild | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Any | 56.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Any | 62.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Mild | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >=38 degrees C | 4.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Any | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Any | 4.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Mild | 35.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Moderate | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Severe | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Moderate | 7.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Moderate | 23.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Moderate | 20.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.5 to <39.0 degrees C | 1.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.0 to <38.5 degrees C | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Use of antipyretic medication | 7.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Moderate | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Mild | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Mild | 22.2 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Moderate | 25.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Severe | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Any | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Mild | 7.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Any | 51.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Mild | 24.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Moderate | 24.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >40.0 degrees C | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Severe | 3.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Any | 18.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Moderate | 9.3 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Mild | 9.3 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 39.0 to 40.0 degrees C | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Moderate | 7.4 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >=38 degrees C | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Severe | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Use of antipyretic medication | 13.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Any | 24.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.5 to <39.0 degrees C | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain: Mild | 14.8 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Severe | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Moderate | 5.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Severe | 3.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Severe | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.0 to <38.5 degrees C | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Any | 5.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Mild | 5.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Any | 48.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Moderate | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Any | 18.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Moderate | 12.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >=38 degrees C | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Mild | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Moderate | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.0 to <38.5 degrees C | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever >40.0 degrees C | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Moderate | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Use of antipyretic medication | 6.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Mild | 31.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Any | 21.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Mild | 12.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Mild | 25.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Any | 18.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Moderate | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Moderate | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Joint pain:Moderate | 9.4 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Any | 65.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Mild | 18.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 38.5 to <39.0 degrees C | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Headache:Any | 37.5 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fever 39.0 to 40.0 degrees C | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Mild | 18.8 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain:Any | 15.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Diarrhea:Severe | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Chills:Any | 28.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Severe | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Vomiting:Any | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Muscle pain: Mild | 6.3 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination | Fatigue:Moderate | 31.3 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8)
An AE was any untoward medical occurrence 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. AEs included both non-serious AEs and serious adverse events (SAEs). An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Time frame: From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage
Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | AE | 6.8 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | SAE | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | NDCMC | 0.0 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | MAE | 5.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | AE | 8.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | MAE | 4.3 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | SAE | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | NDCMC | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | MAE | 4.7 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | SAE | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | NDCMC | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | AE | 12.5 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | AE | 3.7 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | SAE | 1.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | MAE | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | NDCMC | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | MAE | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | NDCMC | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | SAE | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) | AE | 12.5 percentage of participants |
Primary
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Time frame: Within 30 minutes after Booster Vaccination in Month 48
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination | 0.0 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10)
An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.
Time frame: From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | 1.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | 2.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10) | 0.0 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10)
An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.
Time frame: From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | 1.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | 2.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | 0.0 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10) | 0.0 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9)
An AE was any untoward medical occurrence 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. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Time frame: Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage
Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | SAE | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | MAE | 28.8 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | SAE | 0.0 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | MAE | 12.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | SAE | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | MAE | 10.9 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | MAE | 11.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | SAE | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | SAE | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) | MAE | 21.9 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9)
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. An MAE was defined as a nonserious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Time frame: From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)
Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | SAE | 1.7 percentage of participants |
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | MAE | 32.2 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | SAE | 1.1 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | MAE | 15.2 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | SAE | 3.1 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | MAE | 15.6 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | MAE | 11.1 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | SAE | 1.9 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | SAE | 0.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) | MAE | 25.0 percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11)
An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.
Time frame: From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11) | 5.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11) | 0.0 percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11)
An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.
Time frame: From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)
Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11) | 5.4 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11) | 0.0 percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1)
An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.
Time frame: Visit 1 of B1971033 (6-month safety telephone call after last dose in primary study) to Visit 6 of B1971033 (6 months after last primary dose to 48 months after last primary dose in primary study)
Population: Stage 1 safety population included all participants who had at least 1 blood draw in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 5.7 percentage of participants |
| Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 5.0 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 2.2 percentage of participants |
| Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 2.6 percentage of participants |
| Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 2.3 percentage of participants |
| Group 4: rLP2086 (0-and 6-Month Schedule) | Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1) | 2.2 percentage of participants |