Duration of hSBA Response After a Primary Series of Bival... | NCT01543087 | Trialant
NCT01543087
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 27, 2020Actual
Enrollment
698Actual
Phase
Phase 3
Conditions
Meningococcal Infection
Interventions
blood sampling
bivalent rLP2086
Countries
United States
Czechia
Denmark
Finland
Germany
Sweden
Protocol Section
Identification Module
NCT ID
NCT01543087
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1971033
Secondary IDs
ID
Type
Description
Link
2011-005697-31
EudraCT Number
Brief Title
Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
Official Title
A PHASE 3 STUDY TO ASSESS THE PERSISTENCE OF HSBA RESPONSE UP TO 48 MONTHS AFTER COMPLETION OF A PRIMARY SERIES OF BIVALENT RLP2086, AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 7, 2012Actual
Primary Completion Date
Jan 5, 2018Actual
Completion Date
Jan 5, 2018Actual
First Submitted Date
Feb 17, 2012
First Submission Date that Met QC Criteria
Feb 27, 2012
First Posted Date
Mar 2, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2018
Results First Submitted that Met QC Criteria
Mar 26, 2020
Results First Posted Date
Mar 27, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 26, 2020
Last Update Posted Date
Mar 27, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Meningococcal Infection
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
698Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
One group of subjects
Other
Procedure: blood sampling
Drug: bivalent rLP2086
Interventions
Name
Type
Description
Arm Group Labels
Other Names
blood sampling
Procedure
Blood sample collection at different time points
One group of subjects
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Month 6 (Visit 1 of study B1971033)
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).
Month 12 (Visit 2 of study B1971033)
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).
Month 18 (Visit 3 of study B1971033)
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Stage 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.
Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
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.
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):
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.
Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.
Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.
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.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
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.
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):
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.
Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-, 2-, and 6-month or a 0- and 6-month schedule.
Subject must have completed booster vaccination at Visit 7.
Exclusion Criteria for Stage 1:
Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.
Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.
Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines permitted in the primary study).
Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.
Exclusion Criteria for Booster Stage:
Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV) vaccine as part of a 3-dose series during the 28 days after the booster vaccination.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Current chronic use of systemic antibiotics.
Current participation in another investigational study. Participation in purely observational studies is acceptable.
Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol through Visit 10 of the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
10 Years
Maximum Age
18 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Vesikari T, Ostergaard L, Beeslaar J, Absalon J, Eiden JJ, Jansen KU, Jones TR, Harris SL, Maansson R, Munson S, O'Neill RE, York LJ, Perez JL. Persistence and 4-year boosting of the bactericidal response elicited by two- and three-dose schedules of MenB-FHbp: A phase 3 extension study in adolescents. Vaccine. 2019 Mar 14;37(12):1710-1719. doi: 10.1016/j.vaccine.2018.11.073. Epub 2019 Feb 12.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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.
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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule)
Participants received quadrivalent meningococcal polysaccharide conjugate (MCV4) tetanus + acellular pertussis (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.
FG001
Periods
Title
Milestones
Reasons Not Completed
Stage 1 (48 Months)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 18, 2017
Dec 14, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Poland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Not provided
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
bivalent rLP2086
Drug
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.
One group of subjects
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).
Month 24 (Visit 4 of study B1971033)
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).
Month 36 (Visit 5 of study B1971033)
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).
Month 48 (Visit 6 of study B1971033)
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.
1 month after last vaccination in primary study
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.
Visit 6 of study B1971033 (48 months after last vaccination in primary study)
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.
Visit 8 (1 month following the booster vaccination on Month 49)
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.
Visit 10 (12 months following the booster vaccination on Month 60)
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
Visit 11 (26 months following the booster vaccination on Month 74)
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).
Within 7 days after booster vaccination on Month 48
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).
Within 7 days after booster vaccination on Month 48
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.
From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage
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.
Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage
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.
From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)
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.
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)
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.
From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)
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.
From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)
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.
From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)
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.
From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)
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.
Within 30 minutes after Booster Vaccination in Month 48
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.
From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)
Clinical Research Advantage, Inc./ East Valley Family Physicians, PLC
Chandler
Arizona
85224
United States
St. Joseph Heritage Healthcare
Huntington Beach
California
92648
United States
Center For Clinical Trials, LLC
Paramount
California
90723
United States
California Research Foundation
San Diego
California
92123
United States
Bayview Research Group
Valley Village
California
91607
United States
USF Health South Tampa Center for Advanced Healthcare
Tampa
Florida
33606
United States
USF Health
Tampa
Florida
33606
United States
North Georgia Research Clinical Center
Dalton
Georgia
30721
United States
Pediatrics and Adolescent Medicine, PA
Marietta
Georgia
30062
United States
Pediatrics And Adolescent Medicine, P.A.
Woodstock
Georgia
30189
United States
Advanced Clinical Research
Meridian
Idaho
83642
United States
Clinical Research Advantage, Inc.
Council Bluffs
Iowa
51503
United States
Heartland Research Associates, LLC
Augusta
Kansas
67010
United States
Kentucky Pediatric/Adult Research
Bardstown
Kentucky
40004
United States
U of L Pediatrics: Downtown
Louisville
Kentucky
40202
United States
Brownsboro Park Pediatrics
Louisville
Kentucky
40207
United States
Bluegrass Clinical Research, Inc.
Louisville
Kentucky
40291
United States
Southwestern Medical Clinic Lakeland Healthcare Affiliate
Stevensville
Michigan
49127
United States
The Center For Pharmaceutical Research
Kansas City
Missouri
64114
United States
Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
Fremont
Nebraska
68025
United States
Midwest Children's Health Research Institute
Lincoln
Nebraska
68504
United States
Creighton University Pediatric Infectious Diseases
Omaha
Nebraska
68131
United States
Clinical Research Center of Nevada,LLC
Henderson
Nevada
89014
United States
Dr. Shelly David Senders MD Inc. dba Senders Pediatrics
Cleveland
Ohio
44121
United States
Ohio Pediatric Research Association
Dayton
Ohio
45414
United States
Ohio Pediatrics, Inc
Dayton
Ohio
45414
United States
West Houston Clinical Research Service (WHCRS)
Houston
Texas
77055
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
BB Holdings, LLC., dba Jean Brown Research
Salt Lake City
Utah
84124
United States
J. Lewis Research Inc, Jordan River Family Medicine
South Jordan
Utah
84095
United States
Advanced Clinical Research
West Jordan
Utah
84088-9334
United States
The Vancouver Clinic, Inc. PS
Vancouver
Washington
98664
United States
Monroe Clinic
Monroe
Wisconsin
53566
United States
Research and Education Association for Clinical Health, Inc.
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG00070 subjects
FG001103 subjects
FG002277 subjects
FG003116 subjects
FG00486 subjects
FG00546 subjects
Safety Population
Participants who had at least 1 blood draw in this study.
FG00070 subjects
FG001101 subjects
FG002277 subjects
FG003116 subjects
FG00486 subjects
FG00546 subjects
COMPLETED
FG00056 subjects
FG00193 subjects
FG002237 subjects
FG003108 subjects
FG00483 subjects
FG00546 subjects
NOT COMPLETED
FG00014 subjects
FG00110 subjects
FG00240 subjects
FG0038 subjects
FG0043 subjects
FG0050 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0014 subjects
FG00212 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
No longer met eligibility criteria
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
No longer willing to participate
FG0005 subjects
FG0013 subjects
FG00218 subjects
FG0036 subjects
FG004
Other than specified
FG0005 subjects
FG0010 subjects
FG0029 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Booster Stage (26 Months)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsGroup1 participants (primary study B1971015)were not invited to participate in Booster stage (BS).
FG00160 subjectsBS was optional for eligible participants. Not all participants completing stage 1 continued to BS.
FG00292 subjectsBS was optional for eligible participants. Not all participants completing stage 1 continued to BS.
FG00364 subjectsBS was optional for eligible participants. Not all participants completing stage 1 continued to BS.
FG00456 subjectsBS was optional for eligible participants. Not all participants completing stage 1 continued to BS.
FG00532 subjectsBS was optional for eligible participants. Not all participants completing stage 1 continued to BS.
Vaccinated
FG0000 subjects
FG00159 subjects
FG00292 subjects
FG00364 subjects
FG004
COMPLETED
FG0000 subjects
FG00159 subjects
FG00291 subjects
FG00364 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal before booster vaccination
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Full analysis set included all participants enrolled in this study from primary studies B1971010, B1971012, and B1971015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG001103
BG002277
BG003116
BG00486
BG00546
BG006698
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The age of participants enrolled in B1971033 is the age of participants at Stage 1 enrollment.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00011.7± 0.7
BG00115.9± 2.2
BG00214.3± 2.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00155
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00016
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00059
BG001103
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 6 (Visit 1 of study B1971033)
ID
Title
Description
OG000
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.
OG001
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG002
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
Units
Counts
Participants
OG00070
OG00140
OG002123
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG0007
ParticipantsOG00137
ParticipantsOG00218
Title
Measurements
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).
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 12 (Visit 2 of study B1971033)
ID
Title
Description
OG000
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.
OG001
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.
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).
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 18 (Visit 3 of study B1971033)
ID
Title
Description
OG000
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.
OG001
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.
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).
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 24 (Visit 4 of study B1971033)
ID
Title
Description
OG000
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.
OG001
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.
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).
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 36 (Visit 5 of study B1971033)
ID
Title
Description
OG000
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.
OG001
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.
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).
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.
Posted
Number
95% Confidence Interval
percentage of participants
Month 48 (Visit 6 of study B1971033)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after last vaccination in primary study
ID
Title
Description
OG000
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.
OG001
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Visit 6 of study B1971033 (48 months after last vaccination in primary study)
ID
Title
Description
OG000
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.
OG001
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Visit 8 (1 month following the booster vaccination on Month 49)
ID
Title
Description
OG000
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.
OG001
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Visit 10 (12 months following the booster vaccination on Month 60)
ID
Title
Description
OG000
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.
OG001
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
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
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.
Posted
Number
95% Confidence Interval
percentage of participants
Visit 11 (26 months following the booster vaccination on Month 74)
ID
Title
Description
OG000
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
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).
Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
Within 7 days after booster vaccination on Month 48
ID
Title
Description
OG000
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.
OG001
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.
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).
Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
Within 7 days after booster vaccination on Month 48
ID
Title
Description
OG000
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.
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.
Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage
ID
Title
Description
OG000
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.
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.
Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage
ID
Title
Description
OG000
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.
OG001
Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)
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.
Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)
ID
Title
Description
OG000
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.
OG001
Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)
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.
Stage 1 safety population included all participants who had at least 1 blood draw in the study.
Posted
Number
95% Confidence Interval
percentage of participants
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)
ID
Title
Description
OG000
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.
OG001
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.
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.
Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)
ID
Title
Description
OG000
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.
OG001
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.
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.
Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)
ID
Title
Description
OG000
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG001
Group 4: rLP2086 (0-and 6-Month Schedule)
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)
ID
Title
Description
OG000
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG001
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.
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.
Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.
Posted
Number
95% Confidence Interval
percentage of participants
Within 30 minutes after Booster Vaccination in Month 48
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Mean
Standard Deviation
days
From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)
ID
Title
Description
OG000
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.
OG001
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.
Time Frame
SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48.
Description
AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
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.
0
70
0
0
4
70
EG001
Stage 1, 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.
0
101
0
0
0
101
EG002
Stage 1, 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.
0
277
0
0
1
277
EG003
Stage 1, 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.
0
116
0
0
0
116
EG004
Stage 1, 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.
0
86
0
0
2
86
EG005
Stage 1,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.
0
46
0
0
1
46
EG006
Stage 2, 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 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
0
59
1
59
56
59
EG007
Stage 2, 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. 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.
0
92
1
92
90
92
EG008
Stage 2, 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 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
0
64
2
64
62
64
EG009
Stage 2, 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 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
0
54
1
54
53
54
EG010
Stage 2, 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 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
0
32
0
32
31
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Influenza like illness
General disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG0030 at risk
EG0040 at risk
EG0050 at risk
EG0060 affected59 at risk
EG0070 affected92 at risk
EG0080 affected64 at risk
EG0091 affected54 at risk
EG0100 affected32 at risk
Pyelonephritis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Depression
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG0030 affected116 at risk
EG0040 affected86 at risk
EG0050 affected46 at risk
EG0061 affected59 at risk
EG0070 affected92 at risk
EG0080 affected64 at risk
EG0090 affected54 at risk
EG0100 affected32 at risk
Bradycardia
Cardiac disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Myopia
Eye disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Influenza like illness
General disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Mite allergy
Immune system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Body tinea
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Cervicitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Cystitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Genitourinary chlamydia infection
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Impetigo
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Infection
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Influenza
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Tracheitis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Vasoplegia syndrome
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Borrelia test positive
Investigations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Vitamin K deficiency
Metabolism and nutrition disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Brain injury
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Migraine
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Syncope
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Depression
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Gastrointestinal somatic symptom disorder
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hypertension
Vascular disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hypotension
Vascular disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Withdrawal syndrome
General disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Chills
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Fatigue
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Injection site erythema (redness)
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Injection site pain (tenderness at injection site)
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Injection site swelling (swelling)
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Pyrexia (fever)
General disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Headache
Nervous system disorders
MedDRA v 20.1
Systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Hypermetropia
Eye disorders
MedDRA v 20.1
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA v 20.1
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA v 20.1
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected101 at risk
EG0021 affected277 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA v 20.1
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Orthostatic intolerance
Nervous system disorders
MedDRA v 20.1
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected101 at risk
EG0020 affected277 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG004
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00070
OG001101
OG00240
OG003114
OG004123
OG005116
OG00686
OG00746
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00069
ParticipantsOG00199
ParticipantsOG00239
ParticipantsOG003111
ParticipantsOG004122
ParticipantsOG005113
ParticipantsOG00684
ParticipantsOG00746
Title
Measurements
OG00029.0(18.7 to 41.2)
OG00141.4(31.6 to 51.8)
OG00269.2(52.4 to 83.0)
OG003
PMB2001 (A56)
ParticipantsOG00069
ParticipantsOG00198
ParticipantsOG00239
ParticipantsOG003109
PMB2948 (B24)
ParticipantsOG00070
ParticipantsOG00198
ParticipantsOG00240
ParticipantsOG003108
PMB2707 (B44)
ParticipantsOG00070
ParticipantsOG001100
ParticipantsOG00240
ParticipantsOG003111
OG002
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG004
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00070
OG001101
OG00240
OG003114
OG004123
OG005116
OG00686
OG00746
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00069
ParticipantsOG00197
ParticipantsOG00238
ParticipantsOG003112
ParticipantsOG004117
ParticipantsOG005111
ParticipantsOG00685
ParticipantsOG00745
Title
Measurements
OG00023.2(13.9 to 34.9)
OG00137.1(27.5 to 47.5)
OG00257.9(40.8 to 73.7)
OG003
PMB2001 (A56)
ParticipantsOG00067
ParticipantsOG00194
ParticipantsOG00239
ParticipantsOG003106
PMB2948 (B24)
ParticipantsOG00069
ParticipantsOG00196
ParticipantsOG00238
ParticipantsOG003109
PMB2707 (B44)
ParticipantsOG00069
ParticipantsOG00198
ParticipantsOG00238
ParticipantsOG003110
OG002
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG004
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00070
OG001101
OG00240
OG003114
OG004123
OG005116
OG00686
OG00746
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00068
ParticipantsOG00198
ParticipantsOG00238
ParticipantsOG003107
ParticipantsOG004115
ParticipantsOG005109
ParticipantsOG00684
ParticipantsOG00746
Title
Measurements
OG00017.6(9.5 to 28.8)
OG00134.7(25.4 to 45.0)
OG00250.0(33.4 to 66.6)
OG003
PMB2001 (A56)
ParticipantsOG00066
ParticipantsOG00191
ParticipantsOG00238
ParticipantsOG003102
PMB2948 (B24)
ParticipantsOG00068
ParticipantsOG00193
ParticipantsOG00238
ParticipantsOG003107
PMB2707 (B44)
ParticipantsOG00067
ParticipantsOG00197
ParticipantsOG00239
ParticipantsOG003109
OG002
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG004
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule))
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00070
OG001101
OG00240
OG003114
OG004123
OG005116
OG00686
OG00746
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00058
ParticipantsOG00196
ParticipantsOG00238
ParticipantsOG003102
ParticipantsOG004107
ParticipantsOG005108
ParticipantsOG00682
ParticipantsOG00744
Title
Measurements
OG00027.6(16.7 to 40.9)
OG00141.7(31.7 to 52.2)
OG00260.5(43.4 to 76.0)
OG003
PMB2001 (A56)
ParticipantsOG00057
ParticipantsOG00194
ParticipantsOG00237
ParticipantsOG00392
PMB2948 (B24)
ParticipantsOG00059
ParticipantsOG00193
ParticipantsOG00236
ParticipantsOG003100
PMB2707 (B44)
ParticipantsOG00059
ParticipantsOG00197
ParticipantsOG00239
ParticipantsOG003103
OG002
Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG004
Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015 received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of this study.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG00070
OG001101
OG00240
OG003114
OG004123
OG005116
OG00686
OG00746
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00055
ParticipantsOG00190
ParticipantsOG00235
ParticipantsOG003100
ParticipantsOG004101
ParticipantsOG005101
ParticipantsOG00681
ParticipantsOG00746
Title
Measurements
OG00016.4(7.8 to 28.8)
OG00141.1(30.8 to 52.0)
OG00251.4(34.0 to 68.6)
OG003
PMB2001 (A56)
ParticipantsOG00051
ParticipantsOG00185
ParticipantsOG00233
ParticipantsOG00399
PMB2948 (B24)
ParticipantsOG00056
ParticipantsOG00190
ParticipantsOG00234
ParticipantsOG00398
PMB2707 (B44)
ParticipantsOG00056
ParticipantsOG00192
ParticipantsOG00234
ParticipantsOG003100
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG002
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00059
OG00131
OG00258
OG00362
OG00454
OG00532
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00059
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG00361
ParticipantsOG00454
ParticipantsOG00532
Title
Measurements
OG00089.8(79.2 to 96.2)
OG001100.0(88.8 to 100.0)
OG00291.2(80.7 to 97.1)
OG003
PMB2001 (A56)
ParticipantsOG00058
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG00362
PMB2948 (B24)
ParticipantsOG00059
ParticipantsOG00131
ParticipantsOG00258
ParticipantsOG00360
PMB2707 (B44)
ParticipantsOG00058
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG00360
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG002
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00059
OG00131
OG00258
OG00362
OG00454
OG00532
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00059
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG00361
ParticipantsOG00454
ParticipantsOG00531
Title
Measurements
OG00049.2(35.9 to 62.5)
OG00148.4(30.2 to 66.9)
OG00256.1(42.4 to 69.3)
OG003
PMB2001 (A56)
ParticipantsOG00053
ParticipantsOG00129
ParticipantsOG00255
ParticipantsOG00362
PMB2948 (B24)
ParticipantsOG00059
ParticipantsOG00130
ParticipantsOG00257
ParticipantsOG00362
PMB2707 (B44)
ParticipantsOG00057
ParticipantsOG00130
ParticipantsOG00257
ParticipantsOG00362
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG002
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00059
OG00131
OG00258
OG00362
OG00454
OG00532
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00059
ParticipantsOG00131
ParticipantsOG00258
ParticipantsOG00360
ParticipantsOG00453
ParticipantsOG00532
Title
Measurements
OG000100.0(93.9 to 100.0)
OG00196.8(83.3 to 99.9)
OG002100.0(93.8 to 100.0)
OG003
PMB2001 (A56)
ParticipantsOG00057
ParticipantsOG00130
ParticipantsOG00256
ParticipantsOG00362
PMB2948 (B24)
ParticipantsOG00058
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG00362
PMB2707 (B44)
ParticipantsOG00059
ParticipantsOG00131
ParticipantsOG00258
ParticipantsOG00361
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG002
Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule)
Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00059
OG00131
OG00258
OG00362
OG00454
OG00532
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00058
ParticipantsOG00128
ParticipantsOG00254
ParticipantsOG00360
ParticipantsOG00451
ParticipantsOG00531
Title
Measurements
OG00074.1(61.0 to 84.7)
OG00189.3(71.8 to 97.7)
OG00277.8(64.4 to 88.0)
OG003
PMB2001 (A56)
ParticipantsOG00055
ParticipantsOG00124
ParticipantsOG00255
ParticipantsOG00359
PMB2948 (B24)
ParticipantsOG00058
ParticipantsOG00130
ParticipantsOG00254
ParticipantsOG00362
PMB2707 (B44)
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00253
ParticipantsOG00361
OG001
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.
Units
Counts
Participants
OG00058
OG00162
Title
Denominators
Categories
PMB80 (A22)
ParticipantsOG00034
ParticipantsOG00142
Title
Measurements
OG00073.5(55.6 to 87.1)
OG00161.9(45.6 to 76.4)
PMB2001 (A56)
ParticipantsOG00029
ParticipantsOG00140
Title
Measurements
OG00082.8(64.2 to 94.2)
OG001
PMB2948 (B24)
ParticipantsOG00033
ParticipantsOG00142
Title
Measurements
OG00078.8(61.1 to 91.0)
OG001
PMB2707 (B44)
ParticipantsOG00033
ParticipantsOG00143
Title
Measurements
OG00066.7(48.2 to 82.0)
OG001
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
Pain at injection site:Any
Title
Measurements
OG00091.5(81.3 to 97.2)
OG00193.5(86.3 to 97.6)
OG00289.1(78.8 to 95.5)
OG00388.9(77.4 to 95.8)
OG00484.4(67.2 to 94.7)
Pain at injection site:Mild
Title
Measurements
OG00037.3(25.0 to 50.9)
OG00129.3(20.3 to 39.8)
OG00228.1(17.6 to 40.8)
OG003
Pain at injection site:Moderate
Title
Measurements
OG00040.7(28.1 to 54.3)
OG00154.3(43.6 to 64.8)
OG00251.6(38.7 to 64.2)
OG003
Pain at injection site:Severe
Title
Measurements
OG00013.6(6.0 to 25.0)
OG0019.8(4.6 to 17.8)
OG0029.4(3.5 to 19.3)
OG003
Redness:Any
Title
Measurements
OG00020.3(11.0 to 32.8)
OG00120.7(12.9 to 30.4)
OG00220.3(11.3 to 32.2)
OG003
Redness:Mild
Title
Measurements
OG0006.8(1.9 to 16.5)
OG0015.4(1.8 to 12.2)
OG00210.9(4.5 to 21.2)
OG003
Redness:Moderate
Title
Measurements
OG00011.9(4.9 to 22.9)
OG00110.9(5.3 to 19.1)
OG0027.8(2.6 to 17.3)
OG003
Redness:Severe
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0014.3(1.2 to 10.8)
OG0021.6(0.0 to 8.4)
OG003
Swelling:Any
Title
Measurements
OG00018.6(9.7 to 30.9)
OG00120.7(12.9 to 30.4)
OG00217.2(8.9 to 28.7)
OG003
Swelling:Mild
Title
Measurements
OG00011.9(4.9 to 22.9)
OG0018.7(3.8 to 16.4)
OG00210.9(4.5 to 21.2)
OG003
Swelling:Moderate
Title
Measurements
OG0006.8(1.9 to 16.5)
OG00110.9(5.3 to 19.1)
OG0026.3(1.7 to 15.2)
OG003
Swelling:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0011.1(0.0 to 5.9)
OG0020.0(0.0 to 5.6)
OG003
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
Fever >=38 degrees C
Title
Measurements
OG0005.1(1.1 to 14.1)
OG0011.1(0.0 to 5.9)
OG0024.7(1.0 to 13.1)
OG0031.9(0.0 to 9.9)
OG0043.1(0.1 to 16.2)
Fever 38.0 to <38.5 degrees C
Title
Measurements
OG0005.1(1.1 to 14.1)
OG0011.1(0.0 to 5.9)
OG0023.1(0.4 to 10.8)
OG003
Fever 38.5 to <39.0 degrees C
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0021.6(0.0 to 8.4)
OG003
Fever 39.0 to 40.0 degrees C
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0020.0(0.0 to 5.6)
OG003
Fever >40.0 degrees C
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0020.0(0.0 to 5.6)
OG003
Vomiting:Any
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0013.3(0.7 to 9.2)
OG0023.1(0.4 to 10.8)
OG003
Vomiting:Mild
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0013.3(0.7 to 9.2)
OG0021.6(0.0 to 8.4)
OG003
Vomiting:Moderate
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0021.6(0.0 to 8.4)
OG003
Vomiting:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0020.0(0.0 to 5.6)
OG003
Diarrhea:Any
Title
Measurements
OG00010.2(3.8 to 20.8)
OG00113.0(6.9 to 21.7)
OG0024.7(1.0 to 13.1)
OG003
Diarrhea:Mild
Title
Measurements
OG0008.5(2.8 to 18.7)
OG00112.0(6.1 to 20.4)
OG0023.1(0.4 to 10.8)
OG003
Diarrhea:Moderate
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0011.1(0.0 to 5.9)
OG0021.6(0.0 to 8.4)
OG003
Diarrhea:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0020.0(0.0 to 5.6)
OG003
Headache:Any
Title
Measurements
OG00050.8(37.5 to 64.1)
OG00147.8(37.3 to 58.5)
OG00256.3(43.3 to 68.6)
OG003
Headache:Mild
Title
Measurements
OG00030.5(19.2 to 43.9)
OG00128.3(19.4 to 38.6)
OG00235.9(24.3 to 48.9)
OG003
Headache:Moderate
Title
Measurements
OG00020.3(11.0 to 32.8)
OG00118.5(11.1 to 27.9)
OG00220.3(11.3 to 32.2)
OG003
Headache:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0011.1(0.0 to 5.9)
OG0020.0(0.0 to 5.6)
OG003
Fatigue:Any
Title
Measurements
OG00062.7(49.1 to 75.0)
OG00160.9(50.1 to 70.9)
OG00262.5(49.5 to 74.3)
OG003
Fatigue:Mild
Title
Measurements
OG00027.1(16.4 to 40.3)
OG00127.2(18.4 to 37.4)
OG00235.9(24.3 to 48.9)
OG003
Fatigue:Moderate
Title
Measurements
OG00032.2(20.6 to 45.6)
OG00131.5(22.2 to 42.0)
OG00223.4(13.8 to 35.7)
OG003
Fatigue:Severe
Title
Measurements
OG0003.4(0.4 to 11.7)
OG0012.2(0.3 to 7.6)
OG0023.1(0.4 to 10.8)
OG003
Chills:Any
Title
Measurements
OG00023.7(13.6 to 36.6)
OG00131.5(22.2 to 42.0)
OG00220.3(11.3 to 32.2)
OG003
Chills:Mild
Title
Measurements
OG00013.6(6.0 to 25.0)
OG00120.7(12.9 to 30.4)
OG00212.5(5.6 to 23.2)
OG003
Chills:Moderate
Title
Measurements
OG00010.2(3.8 to 20.8)
OG0019.8(4.6 to 17.8)
OG0027.8(2.6 to 17.3)
OG003
Chills:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0011.1(0.0 to 5.9)
OG0020.0(0.0 to 5.6)
OG003
Muscle pain:Any
Title
Measurements
OG00022.0(12.3 to 34.7)
OG00129.3(20.3 to 39.8)
OG00218.8(10.1 to 30.5)
OG003
Muscle pain: Mild
Title
Measurements
OG00016.9(8.4 to 29.0)
OG00115.2(8.6 to 24.2)
OG0027.8(2.6 to 17.3)
OG003
Muscle pain:Moderate
Title
Measurements
OG0005.1(1.1 to 14.1)
OG00113.0(6.9 to 21.7)
OG0027.8(2.6 to 17.3)
OG003
Muscle pain:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0011.1(0.0 to 5.9)
OG0023.1(0.4 to 10.8)
OG003
Joint pain:Any
Title
Measurements
OG00011.9(4.9 to 22.9)
OG00116.3(9.4 to 25.5)
OG00214.1(6.6 to 25.0)
OG003
Joint pain:Mild
Title
Measurements
OG0008.5(2.8 to 18.7)
OG0019.8(4.6 to 17.8)
OG0027.8(2.6 to 17.3)
OG003
Joint pain:Moderate
Title
Measurements
OG0003.4(0.4 to 11.7)
OG0016.5(2.4 to 13.7)
OG0024.7(1.0 to 13.1)
OG003
Joint pain:Severe
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0021.6(0.0 to 8.4)
OG003
Use of antipyretic medication
Title
Measurements
OG00010.2(3.8 to 20.8)
OG00114.1(7.7 to 23.0)
OG0027.8(2.6 to 17.3)
OG003
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
AE
Title
Measurements
OG0006.8(1.9 to 16.5)
OG0018.7(3.8 to 16.4)
OG00212.5(5.6 to 23.2)
OG0033.7(0.5 to 12.7)
OG00412.5(3.5 to 29.0)
SAE
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0011.1(0.0 to 5.9)
OG0020.0(0.0 to 5.6)
OG003
NDCMC
Title
Measurements
OG0000.0(0.0 to 6.1)
OG0010.0(0.0 to 3.9)
OG0020.0(0.0 to 5.6)
OG003
MAE
Title
Measurements
OG0005.1(1.1 to 14.1)
OG0014.3(1.2 to 10.8)
OG0024.7(1.0 to 13.1)
OG003
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
SAE
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0010.0(0.0 to 3.9)
OG0023.1(0.4 to 10.8)
OG0030.0(0.0 to 6.6)
OG0040.0(0.0 to 10.9)
MAE
Title
Measurements
OG00028.8(17.8 to 42.1)
OG00112.0(6.1 to 20.4)
OG00210.9(4.5 to 21.2)
OG003
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
SAE
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0011.1(0.0 to 5.9)
OG0023.1(0.4 to 10.8)
OG0031.9(0.0 to 9.9)
OG0040.0(0.0 to 10.9)
MAE
Title
Measurements
OG00032.2(20.6 to 45.6)
OG00115.2(8.6 to 24.2)
OG00215.6(7.8 to 26.9)
OG003
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00070
OG001101
OG002277
OG003116
OG00486
OG00546
Title
Denominators
Categories
Title
Measurements
OG0005.7(1.6 to 14.0)
OG0015.0(1.6 to 11.2)
OG0022.2(0.8 to 4.7)
OG0032.6(0.5 to 7.4)
OG0042.3(0.3 to 8.1)
OG0052.2(0.1 to 11.5)
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0012.2(0.3 to 7.6)
OG0020.0(0.0 to 5.6)
OG0030.0(0.0 to 6.6)
OG0040.0(0.0 to 10.9)
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
Title
Measurements
OG0001.7(0.0 to 9.1)
OG0012.2(0.3 to 7.6)
OG0020.0(0.0 to 5.6)
OG0030.0(0.0 to 6.6)
OG0040.0(0.0 to 10.9)
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.
Units
Counts
Participants
OG00037
OG00149
Title
Denominators
Categories
Title
Measurements
OG0005.4(0.7 to 18.2)
OG0010.0(0.0 to 7.3)
Units
Counts
Participants
OG00037
OG00149
Title
Denominators
Categories
Title
Measurements
OG0005.4(0.7 to 18.2)
OG0010.0(0.0 to 7.3)
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00059
OG00192
OG00264
OG00354
OG00432
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.0(0.0 to 0.0)
OG0020.0(0.0 to 0.0)
OG0030.0(0.0 to 0.0)
OG0040.0(0.0 to 0.0)
OG002
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.
OG003
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.
OG004
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.