Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bivalent rLP2086 Vaccine · 2 trials · 1 indication
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.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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
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).
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).
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.
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.
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.
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 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 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 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.
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.
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.
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.
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).
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 centimeter \[cm\]), moderate (2.5 to 7.0 cm) and severe (\>7.0 cm).
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\>7.0 cm).
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\>7.0 cm).
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \>39.5 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \>39.5 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \>39.5 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
SAE was an adverse event (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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. 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; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
| Arm | Type | Description |
|---|---|---|
| One group of subjects | OTHER | - |
| Bivalent rLP2086 | EXPERIMENTAL | Bivalent rLP2086 (containing 60 μg each of a purified subfamily A and subfamily B rLP2086 protein, adsorbed to aluminum in a sterile buffered isotonic suspension) in a 0.5-mL dose for injection. |
| Licensed pediatric hepatitis A vaccine | OTHER | - |
| Name | Type | Description |
|---|---|---|
| blood sampling | PROCEDURE | Blood sample collection at different time points |
| 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. |
| Bivalent rLP2086 Vaccine | BIOLOGICAL | 1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm. |
| Licensed pediatric hepatits A vaccine | BIOLOGICAL | 1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm. |
| Normal Saline | OTHER | Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2. |
Inclusion Criteria for Stage 1: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, laborat...
Bivalent rLP2086 Vaccine is an investigational vaccine being studied for the prevention of meningococcal infection, specifically Neisseria meningitidis serogroup B. It is being developed by Pfizer, Inc. (NYSE: PFE) and has been evaluated in clinical trials involving healthy subjects, including children as young as 24 months.
Bivalent rLP2086 Vaccine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The vaccine is currently in clinical development for the prevention of meningococcal infection.
Bivalent rLP2086 Vaccine has completed Phase 3 clinical trials. It is an investigational vaccine and has not been approved by regulatory authorities. The completed trials include a Phase 3 study and a Phase 2 study, both of which have finished enrollment and data collection.
Bivalent rLP2086 Vaccine has completed two clinical trials. NCT01543087 was a Phase 3 study evaluating the duration of immune response after a primary series and booster dose in 698 participants aged 10 years and older. NCT02531698 was a Phase 2 study in 400 healthy children aged 24 months to under 10 years, assessing immunogenicity, safety, and tolerability.
Bivalent rLP2086 Vaccine is designed to elicit an immune response against Neisseria meningitidis serogroup B by targeting the factor H binding protein (fHbp) on the bacterial surface. The vaccine contains two recombinant lipidated 2086 protein variants, which are intended to generate bactericidal antibodies that neutralize the bacteria.