| Primary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 | 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). | Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 2 HAV/Saline (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | | OG003 | Group 2 HAV/Saline (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. |
| | Units | Counts |
|---|
| Participants | - OG000136
- OG001138
- OG00252
- OG003
|
| | Title | Denominators | Categories |
|---|
| PMB80 [A22] | - ParticipantsOG00068
- ParticipantsOG00167
- ParticipantsOG00225
- ParticipantsOG003
|
| |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 | 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). | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | |
|
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 | 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). | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "number of participants analyzed (N)" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) |
|
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 | 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). | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | |
|
| Primary | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 | 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). | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 | 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). | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | |
|
| Primary | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 | 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). | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 | 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. | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 | 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. | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3 | 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. | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the Vaccination 1 up to 1 month after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase | 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. | Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here "N" signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after Vaccination 3 up to 6 months after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Vaccination 1 up to 6 months after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1 | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2 | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3 | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the Vaccination 1 up to 1 month after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here "N" signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after Vaccination 3 up to 6 months after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study | A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the Vaccination 1 up to 6 months after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | |
|
| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1 | 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. | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | | Percentage of participants | | Within 30 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2 | 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. | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. | Posted | | Number | | Percentage of participants | | Within 30 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
|
| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3 | 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. | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. | Posted | | Number | | Percentage of participants | | Within 30 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | | Percentage of participants | | Within 30 Days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | | Percentage of participants | | From the Vaccination 1 up to 1 month after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase | 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. | Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. | Posted | | Number | | Percentage of participants | | From 1 month after Vaccination 3 up to 6 months after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study | 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. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | | Percentage of participants | | From the Vaccination 1 up to 6 months after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
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| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
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| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the Vaccination 1 up to 1 month after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | |
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| Primary | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1 | Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. | Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 minutes after Vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
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| Primary | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2 | Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. | Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 minutes after Vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3 | Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. | Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 minutes after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Primary | Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase | | Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. | Posted | | Mean | Standard Deviation | Days | | From the Vaccination 1 up to 1 month after the Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 | Group 2 HAV/Saline (>=24 Months to <10 Years) | |
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| Secondary | Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3 | 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). | Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 2 HAV/Saline (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. |
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| Secondary | Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 | 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). | Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Vaccination 2 and 6 months after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | |
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| Secondary | Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains | | Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. |
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| Secondary | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains | | Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) | Participants from >=24 months to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG001 | Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) | Participants from >=24 months to <4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG002 | Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) | Participants from >=4 years to <10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule. | | OG003 |
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