Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02534935
Collaborator
(none)
396
25
2
54.5
15.8
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
396 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
Actual Study Start Date
:
Aug 31, 2015
Actual Primary Completion Date
:
Aug 21, 2017
Actual Study Completion Date
:
Mar 17, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rLP2086 vaccine Arm stratified by age: ≥12 to <18 months and ≥18 to <24 months |
Biological: rLP2086 vaccine
60 mcg or 120mcg at 0, 2 and 6 months
|
| Active Comparator: Control Arm stratified by age: ≥12 to <18 months and ≥18 to <24 months |
Biological: Pediatric HAV vaccine
0.5-mL dose at months 0 and 6. Normal saline at month 2.
|
Outcome Measures
Primary Outcome Measures
- 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 [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).
- Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 [within 7 Days after Vaccination 1]
Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). 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).
- Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 [within 7 Days after Vaccination 2]
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
- Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 [within 7 Days after Vaccination 3]
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
- Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 [within 7 Days after Vaccination 1]
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
- Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 [within 7 Days after Vaccination 2]
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
- Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 [within 7 Days after Vaccination 3]
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
- Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 [within 30 Days after Vaccination 1]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
- Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 [within 30 Days after Vaccination 2]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
- Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 [within 30 Days after Vaccination 3]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
- Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination [within 30 Days after any Vaccination]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
- Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase [From the Vaccination 1 up to 1 month after Vaccination 3]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
- Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase [From 1 month after Vaccination 3 up to 6 months after Vaccination 3]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
- Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 [From Vaccination 1 up to 6 months after Vaccination 3]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Secondary Outcome Measures
- Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 [1, 6, 12, 24 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).
- Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 [1 month (Mon) after Vaccination (Vac) 2]
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
- Percentage of Participants 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 [Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)]
- Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains [Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)]
- Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination [Within 7 days after booster vaccination]
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (>=2.0 to 7.0 cm) and severe (>7.0 cm).
- Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination [Within 7 days after booster vaccination]
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, >40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily.
- Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination [Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)]
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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
- Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination [Booster vaccination up to 1 month after booster vaccination]
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
- Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination [Within 30 minutes after booster vaccination]
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
- Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination [Before booster vaccination and 1 month after booster vaccination]
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44.
- Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination [Before booster vaccination and 1 month after booster vaccination]
The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
-
Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
-
Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
-
Previous vaccination with any meningococcal serogroup B vaccine.
-
Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
-
Contraindication to vaccination with any HAV vaccine or known latex allergy.
-
A previous anaphylactic reaction to any vaccine or vaccine-related component.
-
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
-
A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
-
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
-
Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
-
Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
-
Current chronic use of systemic antibiotics.
-
Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
-
Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Canberra Hospital | Canberra, Garran | Australian Capital Territory | Australia | 2605 |
| 2 | Australian Clinical Research Network (ACRN) | Maroubra | New South Wales | Australia | 2035 |
| 3 | Maroubra Medical Centre | Maroubra | New South Wales | Australia | 2035 |
| 4 | Women's And Children's Hospital | North Adelaide | South Australia | Australia | 5006 |
| 5 | Murdoch Children's Research Institute | Parkville | Victoria | Australia | 3052 |
| 6 | Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital | Nedlands | Western Australia | Australia | 6009 |
| 7 | Ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | Czechia | 377 01 | |
| 8 | Samostatna ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | Czechia | 377 01 | |
| 9 | Medicentrum 6 s.r.o | Praha 6 - Vokovice | Czechia | 160 00 | |
| 10 | Prakticky Lekar Pro Deti A Mladez | Tynec Nad Sazavou | Czechia | 257 41 | |
| 11 | Espoo Vaccine Research Clinic | Espoo | Finland | 02230 | |
| 12 | Helsinki South Vaccine Research Clinic | Helsinki | Finland | 00100 | |
| 13 | Helsinki East Vaccine Research Clinic | Helsinki | Finland | 00930 | |
| 14 | Jarvenpaa Vaccine Research Center | Jarvenpaa | Finland | 04400 | |
| 15 | Pori Vaccine Research Clinic | Pori | Finland | 28100 | |
| 16 | Tampere Vaccine Research Clinic | Tampere | Finland | 33100 | |
| 17 | Turku Vaccine Research Clinic | Turku | Finland | 20520 | |
| 18 | NZOZ Vitamed | Bydgoszcz | Poland | 85-079 | |
| 19 | Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek | Debica | Poland | 39-200 | |
| 20 | Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka | Krakow | Poland | 31-302 | |
| 21 | Specjalistyczna Praktyka Lekarska GRAVITA | Lodz | Poland | 91-347 | |
| 22 | NZOZ Praktyka Lekarza Rodzinnego Eskulap sp. z o.o | Lublin | Poland | 20-044 | |
| 23 | Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska | Siemianowice Slaskie | Poland | 41-103 | |
| 24 | Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Oddzial Pediatryczny | Trzebnica | Poland | 55-100 | |
| 25 | Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob | Wroclaw | Poland | 50-368 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02534935
Other Study ID Numbers:
- B1971035
- 2011-004400-38
First Posted:
Aug 28, 2015
Last Update Posted:
Sep 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | In Stage 1, participants received 60 or 120 microgram (mcg) of bivalent rLP2086 vaccine or HAV/saline at Month 1, 2 and 6, and then followed up for 24 months. In Stage 2, participants who received bivalent rLP2086 during Stage 1 had a follow up visit at Month 24. Further participants who received 120 mcg bivalent rLP2086 during Stage 1 were eligible for receiving booster vaccination 6 months after Month 24 visit. |
| Arm/Group Title | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|
| Arm/Group Description | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Period Title: Stage 1: 24 Months | |||
| STARTED | 44 | 220 | 132 |
| COMPLETED | 44 | 210 | 127 |
| NOT COMPLETED | 0 | 10 | 5 |
| Period Title: Stage 1: 24 Months | |||
| STARTED | 40 | 174 | 0 |
| COMPLETED | 40 | 170 | 0 |
| NOT COMPLETED | 0 | 4 | 0 |
| Period Title: Stage 1: 24 Months | |||
| STARTED | 0 | 148 | 0 |
| COMPLETED | 0 | 147 | 0 |
| NOT COMPLETED | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. | Total of all reporting groups |
| Overall Participants | 44 | 220 | 132 | 396 |
| Age (months) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [months] |
16.9
(4.08)
|
17.4
(3.54)
|
17.3
(3.58)
|
17.3
(3.61)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
21
47.7%
|
114
51.8%
|
74
56.1%
|
209
52.8%
|
| Male |
23
52.3%
|
106
48.2%
|
58
43.9%
|
187
47.2%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Race: White |
37
84.1%
|
210
95.5%
|
127
96.2%
|
374
94.4%
|
| Race: Asian |
5
11.4%
|
2
0.9%
|
1
0.8%
|
8
2%
|
| Race: Other |
2
4.5%
|
8
3.6%
|
4
3%
|
14
3.5%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Ethnicity: Hispanic |
0
0%
|
2
0.9%
|
0
0%
|
2
0.5%
|
| Ethnicity: Non-Hispanic |
44
100%
|
218
99.1%
|
132
100%
|
394
99.5%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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). |
| Time Frame | 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. |
| Measure Participants | 9 | 11 | 47 | 51 | 31 | 30 |
| PMB80 [A22] |
88.9
202%
|
90.9
41.3%
|
91.1
69%
|
88.2
22.3%
|
3.2
NaN
|
6.9
NaN
|
| PMB2001 [A56] |
100.0
227.3%
|
100.0
45.5%
|
100.0
75.8%
|
100.0
25.3%
|
0.0
NaN
|
3.3
NaN
|
| PMB2948 [B24] |
88.9
202%
|
81.8
37.2%
|
71.1
53.9%
|
72.0
18.2%
|
3.2
NaN
|
6.9
NaN
|
| PMB2707 [B44] |
88.9
202%
|
90.0
40.9%
|
87.2
66.1%
|
85.1
21.5%
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 |
|---|---|
| Description | Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). 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). |
| Time Frame | within 7 Days after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| Tenderness at injection site: Any |
68.2
155%
|
50.0
22.7%
|
59.1
44.8%
|
50.9
12.9%
|
64.5
NaN
|
57.7
NaN
|
15.2
NaN
|
19.7
NaN
|
17.4
NaN
|
| Tenderness at injection site: Mild |
45.5
103.4%
|
27.3
12.4%
|
36.4
27.6%
|
27.3
6.9%
|
34.5
NaN
|
30.9
NaN
|
12.1
NaN
|
19.7
NaN
|
15.9
NaN
|
| Tenderness at injection site: Moderate |
22.7
51.6%
|
18.2
8.3%
|
20.5
15.5%
|
20.9
5.3%
|
24.5
NaN
|
22.7
NaN
|
3.0
NaN
|
0.0
NaN
|
1.5
NaN
|
| Tenderness at injection site: Severe |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
2.7
0.7%
|
5.5
NaN
|
4.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness: Any |
68.2
155%
|
40.9
18.6%
|
54.5
41.3%
|
50.9
12.9%
|
42.7
NaN
|
46.8
NaN
|
13.6
NaN
|
16.7
NaN
|
15.2
NaN
|
| Redness: Mild |
40.9
93%
|
27.3
12.4%
|
34.1
25.8%
|
35.5
9%
|
21.8
NaN
|
28.6
NaN
|
13.6
NaN
|
16.7
NaN
|
15.2
NaN
|
| Redness: Moderate |
27.3
62%
|
13.6
6.2%
|
20.5
15.5%
|
14.5
3.7%
|
19.1
NaN
|
16.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.9
0.2%
|
1.8
NaN
|
1.4
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Swelling: Any |
36.4
82.7%
|
22.7
10.3%
|
29.5
22.3%
|
30.0
7.6%
|
27.3
NaN
|
28.6
NaN
|
7.6
NaN
|
12.1
NaN
|
9.8
NaN
|
| Swelling: Mild |
22.7
51.6%
|
13.6
6.2%
|
18.2
13.8%
|
15.5
3.9%
|
19.1
NaN
|
17.3
NaN
|
7.6
NaN
|
12.1
NaN
|
9.8
NaN
|
| Swelling: Moderate |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
13.6
3.4%
|
8.2
NaN
|
10.9
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Swelling: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.9
0.2%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 |
|---|---|
| Description | Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm). |
| Time Frame | within 7 Days after Vaccination 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 105 | 107 | 212 | 63 | 65 | 128 |
| Tenderness at injection site: Any |
45.5
103.4%
|
50.0
22.7%
|
47.7
36.1%
|
45.7
11.5%
|
60.7
NaN
|
53.3
NaN
|
14.3
NaN
|
15.4
NaN
|
14.8
NaN
|
| Tenderness at injection site: Mild |
31.8
72.3%
|
40.9
18.6%
|
36.4
27.6%
|
31.4
7.9%
|
32.7
NaN
|
32.1
NaN
|
12.7
NaN
|
15.4
NaN
|
14.1
NaN
|
| Tenderness at injection site: Moderate |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
12.4
3.1%
|
24.3
NaN
|
18.4
NaN
|
1.6
NaN
|
0.0
NaN
|
0.8
NaN
|
| Tenderness at injection site: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.9
0.5%
|
3.7
NaN
|
2.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness: Any |
50.0
113.6%
|
31.8
14.5%
|
40.9
31%
|
33.3
8.4%
|
38.3
NaN
|
35.8
NaN
|
6.3
NaN
|
9.2
NaN
|
7.8
NaN
|
| Redness: Mild |
40.9
93%
|
27.3
12.4%
|
34.1
25.8%
|
21.9
5.5%
|
23.4
NaN
|
22.6
NaN
|
6.3
NaN
|
9.2
NaN
|
7.8
NaN
|
| Redness: Moderate |
9.1
20.7%
|
4.5
2%
|
6.8
5.2%
|
11.4
2.9%
|
15.0
NaN
|
13.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Swelling: Any |
18.2
41.4%
|
27.3
12.4%
|
22.7
17.2%
|
21.0
5.3%
|
19.6
NaN
|
20.3
NaN
|
1.6
NaN
|
7.7
NaN
|
4.7
NaN
|
| Swelling: Mild |
18.2
41.4%
|
13.6
6.2%
|
15.9
12%
|
14.3
3.6%
|
13.1
NaN
|
13.7
NaN
|
1.6
NaN
|
7.7
NaN
|
4.7
NaN
|
| Swelling: Moderate |
0.0
0%
|
13.6
6.2%
|
6.8
5.2%
|
6.7
1.7%
|
5.6
NaN
|
6.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Swelling: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.9
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 |
|---|---|
| Description | Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm). |
| Time Frame | within 7 Days after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 104 | 108 | 212 | 65 | 63 | 128 |
| Tenderness at injection site: Any |
54.5
123.9%
|
59.1
26.9%
|
56.8
43%
|
51.9
13.1%
|
62.0
NaN
|
57.1
NaN
|
16.9
NaN
|
14.3
NaN
|
15.6
NaN
|
| Tenderness at injection site: Mild |
22.7
51.6%
|
40.9
18.6%
|
31.8
24.1%
|
29.8
7.5%
|
34.3
NaN
|
32.1
NaN
|
12.3
NaN
|
12.7
NaN
|
12.5
NaN
|
| Tenderness at injection site: Moderate |
31.8
72.3%
|
18.2
8.3%
|
25.0
18.9%
|
17.3
4.4%
|
22.2
NaN
|
19.8
NaN
|
4.6
NaN
|
1.6
NaN
|
3.1
NaN
|
| Tenderness at injection site: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.8
1.2%
|
5.6
NaN
|
5.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness: Any |
40.9
93%
|
36.4
16.5%
|
38.6
29.2%
|
32.7
8.3%
|
33.3
NaN
|
33.0
NaN
|
7.7
NaN
|
7.9
NaN
|
7.8
NaN
|
| Redness: Mild |
31.8
72.3%
|
27.3
12.4%
|
29.5
22.3%
|
23.1
5.8%
|
18.5
NaN
|
20.8
NaN
|
6.2
NaN
|
7.9
NaN
|
7.0
NaN
|
| Redness: Moderate |
9.1
20.7%
|
9.1
4.1%
|
9.1
6.9%
|
8.7
2.2%
|
14.8
NaN
|
11.8
NaN
|
1.5
NaN
|
0.0
NaN
|
0.8
NaN
|
| Redness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.0
0.3%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Swelling: Any |
18.2
41.4%
|
27.3
12.4%
|
22.7
17.2%
|
23.1
5.8%
|
22.2
NaN
|
22.6
NaN
|
4.6
NaN
|
6.3
NaN
|
5.5
NaN
|
| Swelling: Mild |
9.1
20.7%
|
13.6
6.2%
|
11.4
8.6%
|
16.3
4.1%
|
11.1
NaN
|
13.7
NaN
|
4.6
NaN
|
4.8
NaN
|
4.7
NaN
|
| Swelling: Moderate |
9.1
20.7%
|
13.6
6.2%
|
11.4
8.6%
|
5.8
1.5%
|
11.1
NaN
|
8.5
NaN
|
0.0
NaN
|
1.6
NaN
|
0.8
NaN
|
| Swelling: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.0
0.3%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 |
|---|---|
| Description | Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). |
| Time Frame | within 7 Days after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| Fever >=38 degrees C |
40.9
93%
|
31.8
14.5%
|
36.4
27.6%
|
28.2
7.1%
|
27.3
NaN
|
27.7
NaN
|
10.6
NaN
|
1.5
NaN
|
6.1
NaN
|
| Fever 38 to <38.5 degrees C |
22.7
51.6%
|
18.2
8.3%
|
20.5
15.5%
|
7.3
1.8%
|
7.3
NaN
|
7.3
NaN
|
6.1
NaN
|
1.5
NaN
|
3.8
NaN
|
| Fever 38.5 to <39 degrees C |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
14.5
3.7%
|
13.6
NaN
|
14.1
NaN
|
1.5
NaN
|
0.0
NaN
|
0.8
NaN
|
| Fever 39 to <39.5 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.5
1.1%
|
3.6
NaN
|
4.1
NaN
|
3.0
NaN
|
0.0
NaN
|
1.5
NaN
|
| Fever 39.5 to <=40 degrees C |
4.5
10.2%
|
4.5
2%
|
4.5
3.4%
|
1.8
0.5%
|
1.8
NaN
|
1.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Fever >40 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.9
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Irritability: Any |
63.6
144.5%
|
50.0
22.7%
|
56.8
43%
|
71.8
18.1%
|
60.9
NaN
|
66.4
NaN
|
40.9
NaN
|
33.3
NaN
|
37.1
NaN
|
| Irritability: Mild |
27.3
62%
|
9.1
4.1%
|
18.2
13.8%
|
19.1
4.8%
|
16.4
NaN
|
17.7
NaN
|
10.6
NaN
|
13.6
NaN
|
12.1
NaN
|
| Irritability: Moderate |
31.8
72.3%
|
40.9
18.6%
|
36.4
27.6%
|
46.4
11.7%
|
39.1
NaN
|
42.7
NaN
|
30.3
NaN
|
16.7
NaN
|
23.5
NaN
|
| Irritability: Severe |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
6.4
1.6%
|
5.5
NaN
|
5.9
NaN
|
0.0
NaN
|
3.0
NaN
|
1.5
NaN
|
| Drowsiness: Any |
45.5
103.4%
|
40.9
18.6%
|
43.2
32.7%
|
45.5
11.5%
|
42.7
NaN
|
44.1
NaN
|
25.8
NaN
|
10.6
NaN
|
18.2
NaN
|
| Drowsiness: Mild |
36.4
82.7%
|
31.8
14.5%
|
34.1
25.8%
|
28.2
7.1%
|
24.5
NaN
|
26.4
NaN
|
16.7
NaN
|
6.1
NaN
|
11.4
NaN
|
| Drowsiness: Moderate |
9.1
20.7%
|
9.1
4.1%
|
9.1
6.9%
|
11.8
3%
|
15.5
NaN
|
13.6
NaN
|
7.6
NaN
|
4.5
NaN
|
6.1
NaN
|
| Drowsiness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
5.5
1.4%
|
2.7
NaN
|
4.1
NaN
|
1.5
NaN
|
0.0
NaN
|
0.8
NaN
|
| Loss of or decrease appetite: Any |
36.4
82.7%
|
36.4
16.5%
|
36.4
27.6%
|
44.5
11.2%
|
46.4
NaN
|
45.5
NaN
|
34.8
NaN
|
10.6
NaN
|
22.7
NaN
|
| Loss of or decrease appetite: Mild |
22.7
51.6%
|
18.2
8.3%
|
20.5
15.5%
|
16.4
4.1%
|
24.5
NaN
|
20.5
NaN
|
13.6
NaN
|
7.6
NaN
|
10.6
NaN
|
| Loss of or decrease appetite: Moderate |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
25.5
6.4%
|
14.5
NaN
|
20.0
NaN
|
18.2
NaN
|
1.5
NaN
|
9.8
NaN
|
| Loss of or decrease appetite: Severe |
0.0
0%
|
9.1
4.1%
|
4.5
3.4%
|
2.7
0.7%
|
7.3
NaN
|
5.0
NaN
|
3.0
NaN
|
1.5
NaN
|
2.3
NaN
|
| Antipyretic medication use |
45.5
103.4%
|
59.1
26.9%
|
52.3
39.6%
|
52.7
13.3%
|
40.9
NaN
|
46.8
NaN
|
24.2
NaN
|
15.2
NaN
|
19.7
NaN
|
| Title | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 |
|---|---|
| Description | Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). |
| Time Frame | within 7 Days after Vaccination 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 105 | 107 | 212 | 63 | 65 | 128 |
| Fever >=38 degrees C |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
14.3
3.6%
|
14.0
NaN
|
14.2
NaN
|
6.3
NaN
|
3.1
NaN
|
4.7
NaN
|
| Fever 38 to <38.5 degrees C |
13.6
30.9%
|
0.0
0%
|
6.8
5.2%
|
4.8
1.2%
|
8.4
NaN
|
6.6
NaN
|
4.8
NaN
|
3.1
NaN
|
3.9
NaN
|
| Fever 38.5 to <39 degrees C |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
6.7
1.7%
|
2.8
NaN
|
4.7
NaN
|
1.6
NaN
|
0.0
NaN
|
0.8
NaN
|
| Fever 39 to <39.5 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.9
0.5%
|
1.9
NaN
|
1.9
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Fever 39.5 to <=40 degrees C |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
1.0
0.3%
|
0.9
NaN
|
0.9
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Fever >40 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Irritability: Any |
50.0
113.6%
|
40.9
18.6%
|
45.5
34.5%
|
54.3
13.7%
|
55.1
NaN
|
54.7
NaN
|
31.7
NaN
|
18.5
NaN
|
25.0
NaN
|
| Irritability: Mild |
40.9
93%
|
18.2
8.3%
|
29.5
22.3%
|
19.0
4.8%
|
18.7
NaN
|
18.9
NaN
|
7.9
NaN
|
6.2
NaN
|
7.0
NaN
|
| Irritability: Moderate |
4.5
10.2%
|
22.7
10.3%
|
13.6
10.3%
|
31.4
7.9%
|
34.6
NaN
|
33.0
NaN
|
22.2
NaN
|
9.2
NaN
|
15.6
NaN
|
| Irritability: Severe |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
3.8
1%
|
1.9
NaN
|
2.8
NaN
|
1.6
NaN
|
3.1
NaN
|
2.3
NaN
|
| Drowsiness: Any |
13.6
30.9%
|
18.2
8.3%
|
15.9
12%
|
37.1
9.4%
|
24.3
NaN
|
30.7
NaN
|
19.0
NaN
|
4.6
NaN
|
11.7
NaN
|
| Drowsiness: Mild |
9.1
20.7%
|
18.2
8.3%
|
13.6
10.3%
|
22.9
5.8%
|
14.0
NaN
|
18.4
NaN
|
9.5
NaN
|
4.6
NaN
|
7.0
NaN
|
| Drowsiness: Moderate |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
13.3
3.4%
|
8.4
NaN
|
10.8
NaN
|
7.9
NaN
|
0.0
NaN
|
3.9
NaN
|
| Drowsiness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.0
0.3%
|
1.9
NaN
|
1.4
NaN
|
1.6
NaN
|
0.0
NaN
|
0.8
NaN
|
| Loss of or decreased appetite: Any |
31.8
72.3%
|
18.2
8.3%
|
25.0
18.9%
|
41.0
10.4%
|
31.8
NaN
|
36.3
NaN
|
22.2
NaN
|
13.8
NaN
|
18.0
NaN
|
| Loss of or decreased appetite: Mild |
27.3
62%
|
18.2
8.3%
|
22.7
17.2%
|
19.0
4.8%
|
19.6
NaN
|
19.3
NaN
|
11.1
NaN
|
7.7
NaN
|
9.4
NaN
|
| Loss of or decreased appetite: Moderate |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
17.1
4.3%
|
7.5
NaN
|
12.3
NaN
|
9.5
NaN
|
6.2
NaN
|
7.8
NaN
|
| Loss of or decreased appetite: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.8
1.2%
|
4.7
NaN
|
4.7
NaN
|
1.6
NaN
|
0.0
NaN
|
0.8
NaN
|
| Antipyretic medication use |
45.5
103.4%
|
27.3
12.4%
|
36.4
27.6%
|
35.2
8.9%
|
31.8
NaN
|
33.5
NaN
|
19.0
NaN
|
10.8
NaN
|
14.8
NaN
|
| Title | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 |
|---|---|
| Description | Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were 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. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). |
| Time Frame | within 7 Days after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 104 | 108 | 212 | 65 | 63 | 128 |
| Fever >=38 degrees C |
4.5
10.2%
|
4.5
2%
|
4.5
3.4%
|
10.6
2.7%
|
14.8
NaN
|
12.7
NaN
|
4.6
NaN
|
7.9
NaN
|
6.3
NaN
|
| Fever 38 to <38.5 degrees C |
4.5
10.2%
|
4.5
2%
|
4.5
3.4%
|
6.7
1.7%
|
6.5
NaN
|
6.6
NaN
|
3.1
NaN
|
4.8
NaN
|
3.9
NaN
|
| Fever 38.5 to <39 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.9
0.7%
|
1.9
NaN
|
2.4
NaN
|
1.5
NaN
|
1.6
NaN
|
1.6
NaN
|
| Fever 39 to <39.5 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.0
0.3%
|
3.7
NaN
|
2.4
NaN
|
0.0
NaN
|
1.6
NaN
|
0.8
NaN
|
| Fever 39.5 to <=40 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.8
NaN
|
1.4
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Fever >40 degrees C |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Irritability: Any |
36.4
82.7%
|
36.4
16.5%
|
36.4
27.6%
|
56.7
14.3%
|
44.4
NaN
|
50.5
NaN
|
24.6
NaN
|
30.2
NaN
|
27.3
NaN
|
| Irritability: Mild |
22.7
51.6%
|
18.2
8.3%
|
20.5
15.5%
|
27.9
7%
|
19.4
NaN
|
23.6
NaN
|
9.2
NaN
|
15.9
NaN
|
12.5
NaN
|
| Irritability: Moderate |
13.6
30.9%
|
18.2
8.3%
|
15.9
12%
|
26.0
6.6%
|
24.1
NaN
|
25.0
NaN
|
13.8
NaN
|
12.7
NaN
|
13.3
NaN
|
| Irritability: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.9
0.7%
|
0.9
NaN
|
1.9
NaN
|
1.5
NaN
|
1.6
NaN
|
1.6
NaN
|
| Drowsiness: Any |
4.5
10.2%
|
22.7
10.3%
|
13.6
10.3%
|
37.5
9.5%
|
30.6
NaN
|
34.0
NaN
|
13.8
NaN
|
12.7
NaN
|
13.3
NaN
|
| Drowsiness: Mild |
4.5
10.2%
|
22.7
10.3%
|
13.6
10.3%
|
24.0
6.1%
|
23.1
NaN
|
23.6
NaN
|
10.8
NaN
|
9.5
NaN
|
10.2
NaN
|
| Drowsiness: Moderate |
0.0
0%
|
0.0
0%
|
0.0
0%
|
10.6
2.7%
|
6.5
NaN
|
8.5
NaN
|
3.1
NaN
|
1.6
NaN
|
2.3
NaN
|
| Drowsiness: Severe |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.9
0.7%
|
0.9
NaN
|
1.9
NaN
|
0.0
NaN
|
1.6
NaN
|
0.8
NaN
|
| Loss of or decreased appetite: Any |
13.6
30.9%
|
22.7
10.3%
|
18.2
13.8%
|
33.7
8.5%
|
35.2
NaN
|
34.4
NaN
|
16.9
NaN
|
19.0
NaN
|
18.0
NaN
|
| Loss of or decreased appetite: Mild |
13.6
30.9%
|
22.7
10.3%
|
15.9
12%
|
15.4
3.9%
|
18.5
NaN
|
17.0
NaN
|
9.2
NaN
|
15.9
NaN
|
12.5
NaN
|
| Loss of or decreased appetite: Moderate |
0.0
0%
|
0.0
0%
|
0.0
0%
|
14.4
3.6%
|
14.8
NaN
|
14.6
NaN
|
7.7
NaN
|
1.6
NaN
|
4.7
NaN
|
| Loss of or decreased appetite: Severe |
0.0
0%
|
0.0
0%
|
2.3
1.7%
|
3.8
1%
|
1.9
NaN
|
2.8
NaN
|
0.0
NaN
|
1.6
NaN
|
0.8
NaN
|
| Antipyretic medication use |
18.2
41.4%
|
18.2
8.3%
|
18.2
13.8%
|
34.6
8.7%
|
33.3
NaN
|
34.0
NaN
|
13.8
NaN
|
15.9
NaN
|
14.8
NaN
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Time Frame | within 30 Days after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| AE |
18.2
41.4%
|
45.5
20.7%
|
31.8
24.1%
|
38.2
9.6%
|
41.8
NaN
|
40.0
NaN
|
33.3
NaN
|
27.3
NaN
|
30.3
NaN
|
| SAE |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
0.9
0.2%
|
1.8
NaN
|
1.4
NaN
|
1.5
NaN
|
1.5
NaN
|
1.5
NaN
|
| MAE |
9.1
20.7%
|
13.6
6.2%
|
11.4
8.6%
|
18.2
4.6%
|
19.1
NaN
|
18.6
NaN
|
18.2
NaN
|
16.7
NaN
|
17.4
NaN
|
| NDCMC |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| IAE |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Time Frame | within 30 Days after Vaccination 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 105 | 108 | 213 | 66 | 65 | 131 |
| AE |
18.2
41.4%
|
27.3
12.4%
|
22.7
17.2%
|
34.3
8.7%
|
34.3
NaN
|
34.3
NaN
|
24.2
NaN
|
32.3
NaN
|
28.2
NaN
|
| SAE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
3.8
1%
|
0.0
NaN
|
1.9
NaN
|
1.5
NaN
|
0.0
NaN
|
0.8
NaN
|
| MAE |
13.6
30.9%
|
9.1
4.1%
|
11.4
8.6%
|
16.2
4.1%
|
18.5
NaN
|
17.4
NaN
|
13.6
NaN
|
23.1
NaN
|
18.3
NaN
|
| NDCMC |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| IAE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Time Frame | within 30 Days after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 104 | 108 | 212 | 65 | 64 | 129 |
| AE |
18.2
41.4%
|
40.9
18.6%
|
29.5
22.3%
|
25.0
6.3%
|
30.6
NaN
|
27.8
NaN
|
24.6
NaN
|
28.1
NaN
|
26.4
NaN
|
| SAE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
1.0
0.3%
|
0.0
NaN
|
0.5
NaN
|
1.5
NaN
|
0.0
NaN
|
0.8
NaN
|
| MAE |
9.1
20.7%
|
27.3
12.4%
|
18.2
13.8%
|
13.5
3.4%
|
16.7
NaN
|
15.1
NaN
|
12.3
NaN
|
20.3
NaN
|
16.3
NaN
|
| NDCMC |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| IAE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. |
| Time Frame | within 30 Days after any Vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| AE |
36.4
82.7%
|
63.6
28.9%
|
50.0
37.9%
|
54.5
13.8%
|
61.8
NaN
|
58.2
NaN
|
53.0
NaN
|
54.5
NaN
|
53.8
NaN
|
| SAE |
0.0
0%
|
4.5
2%
|
2.3
1.7%
|
5.5
1.4%
|
1.8
NaN
|
3.6
NaN
|
4.5
NaN
|
1.5
NaN
|
3.0
NaN
|
| MAE |
22.7
51.6%
|
40.9
18.6%
|
31.8
24.1%
|
32.7
8.3%
|
40.0
NaN
|
36.4
NaN
|
31.8
NaN
|
39.4
NaN
|
35.6
NaN
|
| NDCMC |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. |
| Time Frame | From the Vaccination 1 up to 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| AE |
54.5
123.9%
|
77.3
35.1%
|
65.9
49.9%
|
68.2
17.2%
|
71.8
NaN
|
70.0
NaN
|
65.2
NaN
|
63.6
NaN
|
64.4
NaN
|
| SAE |
0.0
0%
|
9.1
4.1%
|
4.5
3.4%
|
10.9
2.8%
|
3.6
NaN
|
7.3
NaN
|
4.5
NaN
|
6.1
NaN
|
5.3
NaN
|
| MAE |
36.4
82.7%
|
45.5
20.7%
|
40.9
31%
|
47.3
11.9%
|
54.5
NaN
|
50.9
NaN
|
42.4
NaN
|
43.9
NaN
|
43.2
NaN
|
| NDCMC |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. |
| Time Frame | From 1 month after Vaccination 3 up to 6 months after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here "N" signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 108 | 107 | 215 | 65 | 63 | 128 |
| SAE |
4.5
10.2%
|
9.1
4.1%
|
6.8
5.2%
|
0.9
0.2%
|
3.7
NaN
|
2.3
NaN
|
1.5
NaN
|
1.6
NaN
|
1.6
NaN
|
| MAE |
22.7
51.6%
|
40.9
18.6%
|
31.8
24.1%
|
29.6
7.5%
|
32.7
NaN
|
31.2
NaN
|
30.8
NaN
|
28.6
NaN
|
29.7
NaN
|
| NDCMC |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. |
| Time Frame | From Vaccination 1 up to 6 months after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 22 | 22 | 44 | 110 | 110 | 220 | 66 | 66 | 132 |
| SAE |
4.5
10.2%
|
13.6
6.2%
|
9.1
6.9%
|
10.9
2.8%
|
6.4
NaN
|
8.6
NaN
|
6.1
NaN
|
6.1
NaN
|
6.1
NaN
|
| MAE |
54.5
123.9%
|
68.2
31%
|
61.4
46.5%
|
54.5
13.8%
|
62.7
NaN
|
58.6
NaN
|
59.1
NaN
|
53.0
NaN
|
56.1
NaN
|
| NDCMC |
4.5
10.2%
|
0.0
0%
|
2.3
1.7%
|
0.0
0%
|
0.9
NaN
|
0.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 |
|---|---|
| Description | Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44). |
| Time Frame | 1, 6, 12, 24 months after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. Here N signifies number of participants evaluable for this outcome measure and "number analyzed" (n) signifies participants evaluable at specific rows. |
| Arm/Group Title | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|
| Arm/Group Description | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 21 | 97 | 60 |
| PMB80 (A22) 1 Month after Vaccination 3 |
90.0
204.5%
|
89.6
40.7%
|
5.0
3.8%
|
| PMB80 (A22): 6 Months after Vaccination 3 |
10.0
22.7%
|
12.4
5.6%
|
3.4
2.6%
|
| PMB80 (A22): 12 Months after Vaccination 3 |
14.3
32.5%
|
6.3
2.9%
|
1.8
1.4%
|
| PMB80 (A22): 24 Months after Vaccination 3 |
0.0
0%
|
3.7
1.7%
|
|
| PMB2001 (A56): 1 Month after Vaccination 3 |
100.0
227.3%
|
100.0
45.5%
|
1.9
1.4%
|
| PMB2001 (A56): 6 months after Vaccination 3 |
61.1
138.9%
|
59.1
26.9%
|
3.8
2.9%
|
| PMB2001 (A56): 12 months after Vaccination 3 |
56.3
128%
|
38.7
17.6%
|
5.7
4.3%
|
| PMB2001 (A56): 24 months after Vaccination 3 |
41.2
93.6%
|
22.8
10.4%
|
|
| PMB2948 (B24): 1 Month after Vaccination 3 |
85.0
193.2%
|
71.6
32.5%
|
5.0
3.8%
|
| PMB2948 (B24): 6 month after Vaccination 3 |
15.0
34.1%
|
10.3
4.7%
|
3.4
2.6%
|
| PMB2948 (B24): 12 month after Vaccination 3 |
9.5
21.6%
|
3.2
1.5%
|
3.6
2.7%
|
| PMB2948 (B24): 24 month after Vaccination 3 |
5.3
12%
|
3.7
1.7%
|
|
| PMB2707 (B44): 1 Month after Vaccination 3 |
89.5
203.4%
|
86.2
39.2%
|
0.0
0%
|
| PMB2707 (B44): 6 month after Vaccination 3 |
25.0
56.8%
|
40.4
18.4%
|
1.9
1.4%
|
| PMB2707 (B44): 12 month after Vaccination 3 |
12.5
28.4%
|
17.8
8.1%
|
2.0
1.5%
|
| PMB2707 (B44): 24 month after Vaccination 3 |
11.8
26.8%
|
12.5
5.7%
|
| Title | Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 |
|---|---|
| Description | Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44). |
| Time Frame | 1 month (Mon) after Vaccination (Vac) 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. Here "N" signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 10 | 10 | 19 | 47 | 50 | 95 | 30 | 29 | 59 |
| 1 Mon after Vac2: PMB80[A22] |
90.0
204.5%
|
66.7
30.3%
|
78.9
59.8%
|
64.4
16.3%
|
84.0
NaN
|
74.7
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| 1Mon after Vac2:PMB2001[A56] |
100.0
227.3%
|
90.0
40.9%
|
94.7
71.7%
|
100.0
25.3%
|
100.0
NaN
|
100.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| 1Mon after Vac2:PMB2948[B24] |
70.0
159.1%
|
44.4
20.2%
|
57.9
43.9%
|
23.8
6%
|
43.2
NaN
|
33.7
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| 1Mon after Vac2:PMB2707[B44] |
77.8
176.8%
|
60.0
27.3%
|
68.4
51.8%
|
72.3
18.3%
|
63.8
NaN
|
68.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | 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 |
|---|---|
| Description | |
| Time Frame | Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 10 | 11 | 21 | 47 | 51 | 97 | 31 | 30 | 61 |
| T1: PMB80 [A22] - 1:4 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.3
1.1%
|
3.9
NaN
|
4.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB80 [A22] - 1:8 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
3.9
NaN
|
3.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB80 [A22] - 1:16 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
3.9
NaN
|
3.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB80 [A22] - 1:32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB80 [A22] - 1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
0.0
NaN
|
1.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB80 [A22] - 1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
0.0
NaN
|
1.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2001 (A56)-1:4 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.1
NaN
|
2.1
NaN
|
4.2
NaN
|
0.0
NaN
|
1.9
NaN
|
| T1: PMB2001 (A56)-1:8 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2001 (A56)-1:16 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2001 (A56)-1:32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2001 (A56)-1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2001 (A56)-1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2948 (B24)-1:4 |
0.0
0%
|
9.1
4.1%
|
4.8
3.6%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB2948 (B24)-1:8 |
0.0
0%
|
9.1
4.1%
|
4.8
3.6%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB2948 (B24)-1:16 |
0.0
0%
|
9.1
4.1%
|
4.8
3.6%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB2948 (B24)-1:32 |
0.0
0%
|
9.1
4.1%
|
4.8
3.6%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB2948 (B24)-1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
3.3
NaN
|
1.6
NaN
|
| T1: PMB2948 (B24)-1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:4 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
0.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:8 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
0.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:16 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T1: PMB2707 (B44)-1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB80 [A22] - 1:4 |
90.0
204.5%
|
66.7
30.3%
|
78.9
59.8%
|
64.4
16.3%
|
86.0
NaN
|
75.8
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB80 [A22] - 1:8 |
90.0
204.5%
|
66.7
30.3%
|
78.9
59.8%
|
64.4
16.3%
|
86.0
NaN
|
75.8
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB80 [A22] - 1:32 |
80.0
181.8%
|
44.4
20.2%
|
63.2
47.9%
|
51.1
12.9%
|
66.0
NaN
|
58.9
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB80 [A22] - 1:64 |
50.0
113.6%
|
22.2
10.1%
|
36.8
27.9%
|
28.9
7.3%
|
40.0
NaN
|
34.7
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB80 [A22] - 1:128 |
20.0
45.5%
|
22.2
10.1%
|
21.1
16%
|
11.1
2.8%
|
16.0
NaN
|
13.7
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2001 [A56]- 1:4 |
100.0
227.3%
|
100.0
45.5%
|
100.0
75.8%
|
100.0
25.3%
|
100.0
NaN
|
100.0
NaN
|
4.3
NaN
|
0.0
NaN
|
1.9
NaN
|
| T2: PMB2001 [A56]- 1:16 |
100.0
227.3%
|
90.0
40.9%
|
94.7
71.7%
|
100.0
25.3%
|
100.0
NaN
|
100.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2001 [A56]- 1:32 |
100.0
227.3%
|
90.0
40.9%
|
94.7
71.7%
|
95.7
24.2%
|
95.8
NaN
|
95.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2:PMB2001 [A56]- 1:64 |
100.0
227.3%
|
70.0
31.8%
|
84.2
63.8%
|
87.2
22%
|
85.4
NaN
|
86.3
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2:PMB2001 [A56]-1:128 |
44.4
100.9%
|
50.0
22.7%
|
47.4
35.9%
|
59.6
15.1%
|
54.2
NaN
|
56.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2948 (B24)-1:4 |
70.0
159.1%
|
44.4
20.2%
|
57.9
43.9%
|
28.6
7.2%
|
43.2
NaN
|
36.0
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB2948 (B24)-1:16 |
60.0
136.4%
|
33.3
15.1%
|
47.4
35.9%
|
21.4
5.4%
|
43.2
NaN
|
32.6
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB2948 (B24)-1:32 |
10.0
22.7%
|
0.0
0%
|
5.3
4%
|
9.5
2.4%
|
18.2
NaN
|
14.0
NaN
|
0.0
NaN
|
3.4
NaN
|
1.7
NaN
|
| T2: PMB2948 (B24)-1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.4
0.6%
|
4.5
NaN
|
3.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2948 (B24)-1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.4
0.6%
|
0.0
NaN
|
1.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2707 (B44)-1:4 |
77.8
176.8%
|
70.0
31.8%
|
73.7
55.8%
|
72.3
18.3%
|
63.8
NaN
|
68.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2707 (B44)-1:16 |
77.8
176.8%
|
60.0
27.3%
|
68.4
51.8%
|
72.3
18.3%
|
61.7
NaN
|
67.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2707 (B44)-1:32 |
55.6
126.4%
|
60.0
27.3%
|
57.9
43.9%
|
61.7
15.6%
|
51.1
NaN
|
56.4
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2707 (B44)-1:64 |
33.3
75.7%
|
30.0
13.6%
|
31.6
23.9%
|
27.7
7%
|
21.3
NaN
|
24.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T2: PMB2707 (B44)-1:128 |
11.1
25.2%
|
10.0
4.5%
|
10.5
8%
|
10.6
2.7%
|
10.6
NaN
|
10.6
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3: PMB80 (A22)-1:4 |
88.9
202%
|
90.9
41.3%
|
90.0
68.2%
|
91.1
23%
|
88.2
NaN
|
89.6
NaN
|
6.5
NaN
|
6.9
NaN
|
6.7
NaN
|
| T3: PMB80 (A22)-1:8 |
88.9
202%
|
90.9
41.3%
|
90.0
68.2%
|
91.1
23%
|
88.2
NaN
|
89.6
NaN
|
6.5
NaN
|
6.9
NaN
|
6.7
NaN
|
| T3: PMB80 (A22)-1:32 |
88.9
202%
|
81.8
37.2%
|
85.0
64.4%
|
82.2
20.8%
|
86.3
NaN
|
84.4
NaN
|
3.2
NaN
|
3.4
NaN
|
3.3
NaN
|
| T3: PMB80 (A22)-1:64 |
66.7
151.6%
|
72.7
33%
|
70.0
53%
|
60.0
15.2%
|
72.5
NaN
|
66.7
NaN
|
3.2
NaN
|
0.0
NaN
|
1.7
NaN
|
| T3: PMB80 (A22)-1:128 |
44.4
100.9%
|
54.5
24.8%
|
50.0
37.9%
|
37.8
9.5%
|
49.0
NaN
|
43.8
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3: PMB2001 (A56)-1:4 |
100.0
227.3%
|
100.0
45.5%
|
100.0
75.8%
|
100.0
25.3%
|
100.0
NaN
|
100.0
NaN
|
8.3
NaN
|
10.0
NaN
|
9.3
NaN
|
| T3: PMB2001 (A56)-1:16 |
100.0
227.3%
|
100.0
45.5%
|
100.0
75.8%
|
97.9
24.7%
|
100.0
NaN
|
98.9
NaN
|
0.0
NaN
|
3.3
NaN
|
1.9
NaN
|
| T3: PMB2001 (A56)-1:32 |
100.0
227.3%
|
90.0
40.9%
|
94.7
71.7%
|
97.9
24.7%
|
93.8
NaN
|
95.8
NaN
|
0.0
NaN
|
3.3
NaN
|
1.9
NaN
|
| T3: PMB2001 (A56)-1:64 |
100.0
227.3%
|
80.0
36.4%
|
89.5
67.8%
|
93.6
23.6%
|
85.4
NaN
|
89.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3: PMB2001 (A56)-1:128 |
55.6
126.4%
|
80.0
36.4%
|
68.4
51.8%
|
89.4
22.6%
|
77.1
NaN
|
83.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2948 (B24)-1:4 |
88.9
202%
|
81.8
37.2%
|
85.0
64.4%
|
71.1
18%
|
72.0
NaN
|
71.6
NaN
|
3.2
NaN
|
6.9
NaN
|
5.0
NaN
|
| T3:PMB2948 (B24)-1:16 |
88.9
202%
|
63.6
28.9%
|
75.0
56.8%
|
66.7
16.8%
|
68.0
NaN
|
67.4
NaN
|
3.2
NaN
|
6.9
NaN
|
5.0
NaN
|
| T3:PMB2948 (B24)-1:32 |
44.4
100.9%
|
36.4
16.5%
|
40.0
30.3%
|
37.8
9.5%
|
34.0
NaN
|
35.8
NaN
|
3.2
NaN
|
0.0
NaN
|
1.7
NaN
|
| T3:PMB2948 (B24)-1:64 |
11.1
25.2%
|
18.2
8.3%
|
15.0
11.4%
|
17.8
4.5%
|
10.0
NaN
|
13.7
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2948 (B24)-1:128 |
0.0
0%
|
9.1
4.1%
|
5.0
3.8%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2707 (B44)-1:4 |
88.9
202%
|
90.0
40.9%
|
89.5
67.8%
|
87.2
22%
|
87.2
NaN
|
87.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2707 (B44)-1:16 |
77.8
176.8%
|
90.0
40.9%
|
84.2
63.8%
|
87.2
22%
|
85.1
NaN
|
86.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2707 (B44)-1:32 |
55.6
126.4%
|
70.0
31.8%
|
63.2
47.9%
|
74.5
18.8%
|
78.7
NaN
|
76.6
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2707 (B44)-1:64 |
44.4
100.9%
|
30.0
13.6%
|
36.8
27.9%
|
57.4
14.5%
|
59.6
NaN
|
58.5
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T3:PMB2707 (B44)-1:128 |
22.2
50.5%
|
20.0
9.1%
|
21.1
16%
|
29.8
7.5%
|
34.0
NaN
|
31.9
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB80 (A22): 1: 4 |
20.0
45.5%
|
0.0
0%
|
10.0
7.6%
|
17.4
4.4%
|
7.8
NaN
|
12.4
NaN
|
0.0
NaN
|
7.1
NaN
|
3.4
NaN
|
| T4: PMB80 (A22): 1: 8 |
20.0
45.5%
|
0.0
0%
|
10.0
7.6%
|
17.4
4.4%
|
7.8
NaN
|
12.4
NaN
|
0.0
NaN
|
7.1
NaN
|
3.4
NaN
|
| T4: PMB80 (A22): 1: 16 |
20.0
45.5%
|
0.0
0%
|
10.0
7.6%
|
17.4
4.4%
|
7.8
NaN
|
12.4
NaN
|
0.0
NaN
|
7.1
NaN
|
3.4
NaN
|
| T4: PMB80 (A22): 1: 32 |
10.0
22.7%
|
0.0
0%
|
5.0
3.8%
|
15.2
3.8%
|
5.9
NaN
|
10.3
NaN
|
0.0
NaN
|
3.6
NaN
|
1.7
NaN
|
| T4: PMB80 (A22): 1: 64 |
10.0
22.7%
|
0.0
0%
|
5.0
3.8%
|
6.5
1.6%
|
2.0
NaN
|
4.1
NaN
|
0.0
NaN
|
3.6
NaN
|
1.7
NaN
|
| T4: PMB80 (A22): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2001 (A56): 1:4 |
62.5
142%
|
80.0
36.4%
|
72.2
54.7%
|
65.9
16.6%
|
63.8
NaN
|
64.8
NaN
|
4.2
NaN
|
3.6
NaN
|
3.8
NaN
|
| T4: PMB2001 (A56): 1:8 |
37.5
85.2%
|
80.0
36.4%
|
61.1
46.3%
|
61.0
15.4%
|
57.4
NaN
|
59.1
NaN
|
4.2
NaN
|
3.6
NaN
|
3.8
NaN
|
| T4: PMB2001 (A56): 1:16 |
25.0
56.8%
|
80.0
36.4%
|
55.6
42.1%
|
58.5
14.8%
|
44.7
NaN
|
51.1
NaN
|
0.0
NaN
|
3.6
NaN
|
1.9
NaN
|
| T4: PMB2001 (A56): 1:32 |
25.0
56.8%
|
60.0
27.3%
|
44.5
33.7%
|
34.1
8.6%
|
31.9
NaN
|
33.0
NaN
|
0.0
NaN
|
3.6
NaN
|
1.9
NaN
|
| T4: PMB2001 (A56): 1:64 |
0.0
0%
|
40.0
18.2%
|
22.2
16.8%
|
14.6
3.7%
|
21.3
NaN
|
18.2
NaN
|
0.0
NaN
|
3.6
NaN
|
1.9
NaN
|
| T4: PMB2001 (A56): 1:128 |
0.0
0%
|
20.0
9.1%
|
11.1
8.4%
|
4.9
1.2%
|
8.5
NaN
|
6.8
NaN
|
0.0
NaN
|
3.6
NaN
|
1.9
NaN
|
| T4: PMB2948 (B24): 1: 4 |
20.0
45.5%
|
10.0
4.5%
|
15.0
11.4%
|
10.9
2.8%
|
15.7
NaN
|
13.4
NaN
|
3.3
NaN
|
3.6
NaN
|
3.4
NaN
|
| T4: PMB2948 (B24): 1: 8 |
20.0
45.5%
|
10.0
4.5%
|
15.0
11.4%
|
8.7
2.2%
|
11.8
NaN
|
10.3
NaN
|
3.3
NaN
|
3.6
NaN
|
3.4
NaN
|
| T4: PMB2948 (B24): 1: 16 |
10.0
22.7%
|
10.0
4.5%
|
10.0
7.6%
|
6.5
1.6%
|
11.8
NaN
|
9.3
NaN
|
0.0
NaN
|
3.6
NaN
|
1.7
NaN
|
| T4: PMB2948 (B24): 1: 32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
3.9
NaN
|
2.1
NaN
|
0.0
NaN
|
3.6
NaN
|
1.7
NaN
|
| T4: PMB2948 (B24): 1: 64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2948 (B24): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2707 (B44): 1: 4 |
12.5
28.4%
|
37.5
17%
|
25.0
18.9%
|
44.2
11.2%
|
47.8
NaN
|
46.1
NaN
|
4.2
NaN
|
0.0
NaN
|
1.9
NaN
|
| T4: PMB2707 (B44): 1: 8 |
12.5
28.4%
|
37.5
17%
|
25.0
18.9%
|
39.5
10%
|
41.3
NaN
|
40.4
NaN
|
4.2
NaN
|
0.0
NaN
|
1.9
NaN
|
| T4: PMB2707 (B44): 1: 16 |
12.5
28.4%
|
25.0
11.4%
|
18.8
14.2%
|
34.9
8.8%
|
32.6
NaN
|
33.7
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2707 (B44): 1: 32 |
0.0
0%
|
12.5
5.7%
|
6.3
4.8%
|
11.6
2.9%
|
10.9
NaN
|
11.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2707 (B44): 1: 64 |
0.0
0%
|
12.5
5.7%
|
6.3
4.8%
|
9.3
2.3%
|
2.2
NaN
|
5.6
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T4: PMB2707 (B44): 1: 128 |
0.0
0%
|
12.5
5.7%
|
6.3
4.8%
|
2.3
0.6%
|
0.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB80 (A22): 1:4 |
10.0
22.7%
|
18.2
8.3%
|
14.3
10.8%
|
13.3
3.4%
|
6.0
NaN
|
9.5
NaN
|
3.7
NaN
|
3.6
NaN
|
3.6
NaN
|
| T5: PMB80 (A22): 1: 8 |
10.0
22.7%
|
18.2
8.3%
|
14.3
10.8%
|
11.1
2.8%
|
4.0
NaN
|
7.4
NaN
|
3.7
NaN
|
0.0
NaN
|
1.8
NaN
|
| T5: PMB80 (A22): 1: 16 |
10.0
22.7%
|
18.2
8.3%
|
14.3
10.8%
|
8.9
2.2%
|
4.0
NaN
|
6.3
NaN
|
3.7
NaN
|
0.0
NaN
|
1.8
NaN
|
| T5: PMB80 (A22): 1: 32 |
0.0
0%
|
9.1
4.1%
|
4.8
3.6%
|
4.4
1.1%
|
4.0
NaN
|
4.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB80 (A22): 1: 64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.2
0.6%
|
2.0
NaN
|
2.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB80 (A22): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB2001 (A56): 1: 4 |
33.3
75.7%
|
85.7
39%
|
56.3
42.7%
|
53.3
13.5%
|
52.1
NaN
|
52.7
NaN
|
8.7
NaN
|
10.0
NaN
|
9.4
NaN
|
| T5: PMB2001 (A56): 1: 8 |
33.3
75.7%
|
85.7
39%
|
56.3
42.7%
|
40.0
10.1%
|
37.5
NaN
|
38.7
NaN
|
0.0
NaN
|
10.0
NaN
|
5.7
NaN
|
| T5: PMB2001 (A56): 1: 16 |
33.3
75.7%
|
85.7
39%
|
56.3
42.7%
|
26.7
6.7%
|
31.3
NaN
|
29.0
NaN
|
0.0
NaN
|
10.0
NaN
|
5.7
NaN
|
| T5: PMB2001 (A56): 1: 32 |
22.2
50.5%
|
71.4
32.5%
|
43.8
33.2%
|
17.8
4.5%
|
20.8
NaN
|
19.4
NaN
|
0.0
NaN
|
10.0
NaN
|
5.7
NaN
|
| T5: PMB2001 (A56): 1: 64 |
22.2
50.5%
|
42.9
19.5%
|
31.3
23.7%
|
8.9
2.2%
|
12.5
NaN
|
10.8
NaN
|
0.0
NaN
|
6.7
NaN
|
3.8
NaN
|
| T5: PMB2001 (A56): 1: 128 |
0.0
0%
|
28.6
13%
|
12.5
9.5%
|
4.4
1.1%
|
0.0
NaN
|
2.2
NaN
|
0.0
NaN
|
3.3
NaN
|
1.9
NaN
|
| T5: PMB2948 (B24): 1: 4 |
0.0
0%
|
27.3
12.4%
|
14.3
10.8%
|
2.3
0.6%
|
6.1
NaN
|
4.3
NaN
|
0.0
NaN
|
7.1
NaN
|
3.6
NaN
|
| T5: PMB2948 (B24): 1: 8 |
0.0
0%
|
18.2
8.3%
|
9.5
7.2%
|
2.3
0.6%
|
4.1
NaN
|
3.2
NaN
|
0.0
NaN
|
7.1
NaN
|
3.6
NaN
|
| T5: PMB2948 (B24): 1: 16 |
0.0
0%
|
18.2
8.3%
|
9.5
7.2%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
7.1
NaN
|
3.6
NaN
|
| T5: PMB2948 (B24): 1: 32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
3.6
NaN
|
1.8
NaN
|
| T5: PMB2948 (B24): 1: 64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
3.6
NaN
|
1.8
NaN
|
| T5: PMB2948 (B24): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.0
NaN
|
1.1
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB2707 (B44): 1:4 |
11.1
25.2%
|
14.3
6.5%
|
12.5
9.5%
|
20.9
5.3%
|
21.3
NaN
|
21.1
NaN
|
4.5
NaN
|
3.4
NaN
|
3.9
NaN
|
| T5: PMB2707 (B44): 1:8 |
11.1
25.2%
|
14.3
6.5%
|
12.5
9.5%
|
18.6
4.7%
|
17.0
NaN
|
17.8
NaN
|
0.0
NaN
|
3.4
NaN
|
2.0
NaN
|
| T5: PMB2707 (B44): 1:16 |
0.0
0%
|
14.3
6.5%
|
6.3
4.8%
|
16.3
4.1%
|
8.5
NaN
|
12.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB2707 (B44): 1:32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
4.7
1.2%
|
4.3
NaN
|
4.4
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB2707 (B44): 1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.3
0.6%
|
2.1
NaN
|
2.2
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T5: PMB2707 (B44): 1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| T6: PMB80 (A22): 1:4 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
8.8
2.2%
|
2.1
NaN
|
4.9
NaN
|
|||
| T6: PMB80 (A22): 1:8 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
5.9
1.5%
|
2.1
NaN
|
3.7
NaN
|
|||
| T6: PMB80 (A22): 1:16 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
5.9
1.5%
|
2.1
NaN
|
3.7
NaN
|
|||
| T6: PMB80 (A22): 1:32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
5.9
1.5%
|
2.1
NaN
|
3.7
NaN
|
|||
| T6: PMB80 (A22): 1:64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.9
0.7%
|
2.1
NaN
|
2.5
NaN
|
|||
| T6: PMB80 (A22): 1:128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
|||
| T6: PMB2001 (A56): 1:4 |
22.2
50.5%
|
75.0
34.1%
|
47.1
35.7%
|
20.5
5.2%
|
30.0
NaN
|
25.3
NaN
|
|||
| T6: PMB2001 (A56): 1:8 |
11.1
25.2%
|
75.0
34.1%
|
41.2
31.2%
|
15.4
3.9%
|
30.0
NaN
|
22.8
NaN
|
|||
| T6: PMB2001 (A56): 1:16 |
11.1
25.2%
|
75.0
34.1%
|
41.2
31.2%
|
10.3
2.6%
|
27.5
NaN
|
19.0
NaN
|
|||
| T6: PMB2001 (A56): 1:32 |
11.1
25.2%
|
50.0
22.7%
|
29.4
22.3%
|
2.6
0.7%
|
12.5
NaN
|
7.6
NaN
|
|||
| T6: PMB2001 (A56): 1:64 |
11.1
25.2%
|
0.0
0%
|
5.9
4.5%
|
2.6
0.7%
|
7.5
NaN
|
5.1
NaN
|
|||
| T6: PMB2001 (A56): 1:128 |
11.1
25.2%
|
0.0
0%
|
5.9
4.5%
|
2.6
0.7%
|
5.0
NaN
|
3.8
NaN
|
|||
| T6: PMB2948 (B24): 1: 4 |
0.0
0%
|
11.1
5%
|
5.3
4%
|
8.8
2.2%
|
0.0
NaN
|
3.7
NaN
|
|||
| T6: PMB2948 (B24): 1: 8 |
0.0
0%
|
11.1
5%
|
5.3
4%
|
8.8
2.2%
|
0.0
NaN
|
3.7
NaN
|
|||
| T6: PMB2948 (B24): 1: 16 |
0.0
0%
|
11.1
5%
|
5.3
4%
|
5.9
1.5%
|
0.0
NaN
|
2.4
NaN
|
|||
| T6: PMB2948 (B24): 1: 32 |
0.0
0%
|
11.1
5%
|
5.3
4%
|
5.9
1.5%
|
0.0
NaN
|
2.4
NaN
|
|||
| T6: PMB2948 (B24): 1: 64 |
0.0
0%
|
11.1
5%
|
5.3
4%
|
5.9
1.5%
|
0.0
NaN
|
2.4
NaN
|
|||
| T6: PMB2948 (B24): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.9
0.7%
|
0.0
NaN
|
1.2
NaN
|
|||
| T6: PMB2707 (B44): 1: 4 |
0.0
0%
|
25.0
11.4%
|
11.8
8.9%
|
15.4
3.9%
|
12.2
NaN
|
13.8
NaN
|
|||
| T6: PMB2707 (B44): 1: 8 |
0.0
0%
|
25.0
11.4%
|
11.8
8.9%
|
12.8
3.2%
|
12.2
NaN
|
12.5
NaN
|
|||
| T6: PMB2707 (B44): 1: 16 |
0.0
0%
|
12.5
5.7%
|
5.9
4.5%
|
7.7
1.9%
|
9.8
NaN
|
8.8
NaN
|
|||
| T6: PMB2707 (B44): 1: 32 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
5.1
1.3%
|
2.4
NaN
|
3.8
NaN
|
|||
| T6: PMB2707 (B44): 1: 64 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.4
NaN
|
1.3
NaN
|
|||
| T6: PMB2707 (B44): 1: 128 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
2.4
NaN
|
1.3
NaN
|
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains |
|---|---|
| Description | |
| Time Frame | Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows. |
| Arm/Group Title | Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) | Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <18 Months) | Group 3: HAV/Saline (>=18 Months to <24 Months) | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants from >=12 months to <18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule. | Participants from >=12 months to <18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=18 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. |
| Measure Participants | 10 | 11 | 21 | 47 | 51 | 97 | 31 | 30 | 61 |
| T1:PMB80 (A22) |
8.0
|
8.0
|
8.0
|
8.5
|
8.3
|
8.4
|
8.0
|
8.2
|
8.1
|
| T1: PMB2001 (A56) |
4.0
|
4.0
|
4.0
|
4.0
|
4.2
|
4.1
|
4.0
|
4.0
|
4.0
|
| T1: PMB2948 (B24) |
4.0
|
4.8
|
4.4
|
4.1
|
4.1
|
4.1
|
4.0
|
4.4
|
4.2
|
| T1: PMB2707 (B44) |
4.0
|
4.0
|
4.0
|
4.1
|
4.0
|
4.0
|
4.0
|
4.0
|
4.0
|
| T2: PMB80 (A22) |
42.2
|
23.5
|
32.0
|
24.6
|
36.8
|
30.4
|
8.0
|
8.6
|
8.3
|
| T2: PMB2001 (A56) |
101.6
|
68.6
|
82.6
|
117.2
|
104.6
|
110.6
|
4.0
|
4.0
|
4.0
|
| T2: PMB2948 (B24) |
10.6
|
6.9
|
8.6
|
6.0
|
8.5
|
7.2
|
4.0
|
4.3
|
4.1
|
| T2: PMB2707 (B44) |
23.5
|
21.1
|
22.2
|
22.1
|
17.0
|
19.4
|
4.0
|
4.0
|
40
|
| T3: PMB80 (A22) |
80.6
|
82.3
|
81.6
|
63.0
|
71.4
|
67.3
|
8.6
|
8.6
|
8.6
|
| T3: PMB2001 (A56) |
109.7
|
181.0
|
142.8
|
190.6
|
154.4
|
171.4
|
4.0
|
4.3
|
4.2
|
| T3: PMB2948 (B24) |
20.2
|
17.0
|
18.4
|
15.8
|
14.5
|
15.1
|
4.3
|
4.4
|
4.3
|
| T3: PMB2707 (B44) |
29.6
|
34.3
|
32.0
|
46.3
|
44.9
|
45.6
|
4.0
|
4.0
|
4.0
|
| T4: PMB80 (A22) |
10.6
|
8.0
|
9.2
|
10.8
|
9.0
|
9.8
|
8.0
|
8.8
|
8.4
|
| T4: PMB2001 (A56) |
7.3
|
27.9
|
15.4
|
13.7
|
12.5
|
13.0
|
4.1
|
4.6
|
4.4
|
| T4: PMB2948 (B24) |
4.9
|
4.6
|
4.8
|
4.4
|
4.9
|
4.7
|
4.1
|
4.3
|
4.2
|
| T4: PMB2707 (B44) |
4.8
|
8.7
|
6.4
|
7.9
|
7.3
|
7.6
|
4.1
|
4.0
|
4.1
|
| T5: PMB80 (A22) |
8.6
|
9.7
|
9.1
|
8.9
|
8.6
|
8.7
|
8.2
|
8.0
|
8.1
|
| T5: PMB2001 (A56) |
8.6
|
35.3
|
16.0
|
7.9
|
8.1
|
8.0
|
4.0
|
5.3
|
4.7
|
| T5: PMB2948 (B24) |
4.0
|
5.1
|
4.6
|
4.1
|
4.4
|
4.2
|
4.0
|
4.6
|
4.3
|
| T5: PMB2707 (B44) |
4.3
|
4.9
|
4.6
|
5.3
|
5.0
|
5.2
|
4.0
|
4.1
|
4.1
|
| T6: PMB80 (A22) |
8.0
|
8.0
|
8.0
|
8.9
|
8.4
|
8.6
|
|||
| T6: PMB2001 (A56) |
6.9
|
16.0
|
10.2
|
5.1
|
7.3
|
6.1
|
|||
| T6: PMB2948 (B24) |
4.0
|
5.4
|
4.6
|
4.9
|
4.0
|
4.4
|
|||
| T6: PMB2707 (B44) |
4.0
|
5.2
|
4.5
|
4.8
|
5.0
|
4.9
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination |
|---|---|
| Description | Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (>=2.0 to 7.0 cm) and severe (>7.0 cm). |
| Time Frame | Within 7 days after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 147 |
| Pain at injection site: mild |
30.6
69.5%
|
| Pain at injection site: moderate |
29.3
66.6%
|
| Pain at injection site: severe |
10.2
23.2%
|
| Redness: mild |
22.4
50.9%
|
| Redness: moderate |
21.1
48%
|
| Redness: severe |
4.8
10.9%
|
| Swelling: mild |
18.4
41.8%
|
| Swelling: moderate |
15.0
34.1%
|
| Swelling: severe |
0.0
0%
|
| Title | Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination |
|---|---|
| Description | Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, >40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily. |
| Time Frame | Within 7 days after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 147 |
| Fever >=38 degree C |
10.2
23.2%
|
| Fever 38 to <38.5 degree C |
6.1
13.9%
|
| Fever 38.5 to <39 degree C |
3.4
7.7%
|
| Fever 39 to <39.5 degree C |
0.7
1.6%
|
| Fever 39.5 to <=40 degree C |
0.0
0%
|
| Fever >40 degree C |
0.0
0%
|
| Vomiting: mild |
4.8
10.9%
|
| Vomiting: moderate |
1.4
3.2%
|
| Vomiting: severe |
0.0
0%
|
| Diarrhea: mild |
4.8
10.9%
|
| Diarrhea: moderate |
0.7
1.6%
|
| Diarrhea: severe |
0.0
0%
|
| Headache: mild |
7.5
17%
|
| Headache: moderate |
10.2
23.2%
|
| Headache: severe |
1.4
3.2%
|
| Fatigue: mild |
17.0
38.6%
|
| Fatigue: moderate |
22.4
50.9%
|
| Fatigue: severe |
6.8
15.5%
|
| Muscle pain : mild |
6.1
13.9%
|
| Muscle pain : moderate |
8.2
18.6%
|
| Muscle pain : severe |
2.0
4.5%
|
| Joint pain: mild |
4.1
9.3%
|
| Joint pain: moderate |
6.1
13.9%
|
| Joint pain: severe |
0.0
0%
|
| Antipyretic medication use |
34.7
78.9%
|
| Title | Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination |
|---|---|
| Description | 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; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. |
| Time Frame | Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 147 |
| SAE: T1 |
0.7
1.6%
|
| SAE: T2 |
0.7
1.6%
|
| SAE: T3 |
1.4
3.2%
|
| MAE: T1 |
4.8
10.9%
|
| MAE: T2 |
2.7
6.1%
|
| MAE: T3 |
7.5
17%
|
| NDCMC: T1 |
0.0
0%
|
| NDCMC: T2 |
0.0
0%
|
| NDCMC: T3 |
0.0
0%
|
| Title | Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
| Time Frame | Booster vaccination up to 1 month after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 147 |
| Number (95% Confidence Interval) [percentage of participants] |
13.6
30.9%
|
| Title | Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination |
|---|---|
| Description | Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Time Frame | Within 30 minutes after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 147 |
| Number (95% Confidence Interval) [percentage of participants] |
0.0
0%
|
| Title | Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination |
|---|---|
| Description | Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44. |
| Time Frame | Before booster vaccination and 1 month after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster evaluable immunogenicity population: participants eligible for study, randomized to 120 mcg bivalent rLP2086 during stage 1, received scheduled investigational products, had blood drawn prior to booster vaccination dose and post-booster vaccination blood drawn (Visit 13) within 28-42 days from booster vaccination (Visit 12) and had no important protocol deviation. N=number of participants evaluable for this outcome measure and number analyzed=participants evaluable at specific rows. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 69 |
| PMB80 (A22): before booster vaccination |
2.9
6.6%
|
| PMB80 (A22):1 month after booster vaccination |
92.6
210.5%
|
| PMB2001 (A56):before booster vaccination |
15.2
34.5%
|
| PMB2001 (A56):1 month after booster vaccination |
100.0
227.3%
|
| PMB2948 (B24): before booster vaccination |
7.2
16.4%
|
| PMB2948 (B24):1 month after booster vaccination |
92.8
210.9%
|
| PMB2707 (B44): before booster vaccination |
9.0
20.5%
|
| PMB2707 (B44): 1 month after booster vaccination |
95.7
217.5%
|
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination |
|---|---|
| Description | The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Titers were expressed in terms of 1/dilution. |
| Time Frame | Before booster vaccination and 1 month after booster vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster evaluable immunogenicity population: participants eligible for study, randomized to 120 mcg bivalent rLP2086 during stage 1, received scheduled investigational products, had blood drawn prior to booster vaccination dose and post-booster vaccination blood drawn (Visit 13) within 28-42 days from booster vaccination (Visit 12) and had no important protocol deviation. N=number of participants evaluable for this outcome measure and number analyzed=participants evaluable at specific rows. |
| Arm/Group Title | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase |
|---|---|
| Arm/Group Description | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. |
| Measure Participants | 69 |
| PMB80 (A22): before booster vaccination |
8.4
|
| PMB80 (A22):1 month after booster vaccination |
112.1
|
| PMB2001 (A56):before booster vaccination |
5.2
|
| PMB2001 (A56):1 month after booster vaccination |
248.3
|
| PMB2948 (B24): before booster vaccination |
4.5
|
| PMB2948 (B24):1 month after booster vaccination |
48.3
|
| PMB2707 (B44): before booster vaccination |
4.4
|
| PMB2707 (B44): 1 month after booster vaccination |
98.6
|
Adverse Events
| Time Frame | Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). | |||||||||||||
| Arm/Group Title | Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase | Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up | |||||||
| Arm/Group Description | Participants from greater than or equal to (>=) 12 months to less than (<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination. | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. | Participants from >=12 months to <24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | Participants from >=12 months to <24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | Participants from >=12 months to <24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | |||||||
All Cause Mortality |
||||||||||||||
| Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase | Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase | Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/44 (9.1%) | 19/220 (8.6%) | 8/132 (6.1%) | 2/147 (1.4%) | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Eyelid ptosis | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Enteritis | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastrooesophageal reflux disease | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Inguinal hernia | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Nausea | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Constipation | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 1/147 (0.7%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| General disorders | ||||||||||||||
| Crying | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pyrexia | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Bronchiolitis | 0/44 (0%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Bronchitis | 0/44 (0%) | 1/220 (0.5%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Croup infectious | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Enterovirus infection | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastroenteritis | 0/44 (0%) | 3/220 (1.4%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Otitis media | 0/44 (0%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Otitis media chronic | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pneumonia | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pneumonia respiratory syncytial viral | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Respiratory tract infection viral | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Tonsillitis | 1/44 (2.3%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Urinary tract infection | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral tonsillitis | 0/44 (0%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral upper respiratory tract infection | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rhinovirus infection | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 1/147 (0.7%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Cellulitis | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | |||||||
| Influenza | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Accidental exposure to product | 0/44 (0%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Head injury | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Balance disorder | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Cerebellar ataxia | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Irritability | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Polydipsia psychogenic | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Adenoidal hypertrophy | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Sleep apnoea syndrome | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 1/220 (0.5%) | 0/132 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 | Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | 120-mcg Bivalent rLP2086: Stage 2 Booster Phase | Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 43/44 (97.7%) | 209/220 (95%) | 113/132 (85.6%) | 121/147 (82.3%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Eustachian tube disorder | 1/44 (2.3%) | 1/220 (0.5%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Middle ear effusion | 0/44 (0%) | 8/220 (3.6%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Anisometropia | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Astigmatism | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Conjunctivitis allergic | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Hypermetropia | 1/44 (2.3%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Aphthous ulcer | 3/44 (6.8%) | 1/220 (0.5%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Diarrhoea | 1/44 (2.3%) | 11/220 (5%) | 5/132 (3.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Enteritis | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Flatulence | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Teething | 0/44 (0%) | 8/220 (3.6%) | 4/132 (3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Vomiting | 1/44 (2.3%) | 8/220 (3.6%) | 5/132 (3.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Vomiting | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 9/147 (6.1%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Diarrhoea | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 8/147 (5.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| General disorders | ||||||||||||||
| Chills | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site erythema (redness) | 30/44 (68.2%) | 137/220 (62.3%) | 28/132 (21.2%) | 71/147 (48.3%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site erythema | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site pain (tenderness at injection site) | 35/44 (79.5%) | 160/220 (72.7%) | 41/132 (31.1%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site pain | 1/44 (2.3%) | 4/220 (1.8%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site swelling (swelling) | 17/44 (38.6%) | 103/220 (46.8%) | 20/132 (15.2%) | 49/147 (33.3%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pyrexia (fever) | 16/44 (36.4%) | 82/220 (37.3%) | 20/132 (15.2%) | 15/147 (10.2%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pyrexia | 1/44 (2.3%) | 18/220 (8.2%) | 6/132 (4.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Vaccination site pain | 1/44 (2.3%) | 2/220 (0.9%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Vessel puncture site bruise | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Fatigue | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 68/147 (46.3%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injection site pain | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 103/147 (70.1%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Immune system disorders | ||||||||||||||
| Food allergy | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Bronchiolitis | 0/44 (0%) | 3/220 (1.4%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Bronchitis | 5/44 (11.4%) | 22/220 (10%) | 11/132 (8.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Cellulitis | 1/44 (2.3%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Conjunctivitis | 1/44 (2.3%) | 22/220 (10%) | 13/132 (9.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Croup infectious | 0/44 (0%) | 9/220 (4.1%) | 2/132 (1.5%) | 2/147 (1.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Enterobiasis | 0/44 (0%) | 2/220 (0.9%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Exanthema subitum | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastroenteritis viral | 1/44 (2.3%) | 10/220 (4.5%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Gastroenteritis | 4/44 (9.1%) | 29/220 (13.2%) | 11/132 (8.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Hand-foot-and-mouth disease | 2/44 (4.5%) | 10/220 (4.5%) | 6/132 (4.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Impetigo | 1/44 (2.3%) | 3/220 (1.4%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Infected bite | 1/44 (2.3%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Laryngitis | 2/44 (4.5%) | 3/220 (1.4%) | 5/132 (3.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Lower respiratory tract infection | 0/44 (0%) | 4/220 (1.8%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Molluscum contagiosum | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Nasopharyngitis | 7/44 (15.9%) | 3/220 (1.4%) | 7/132 (5.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Otitis externa | 0/44 (0%) | 0/220 (0%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Otitis media acute | 1/44 (2.3%) | 2/220 (0.9%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Otitis media | 3/44 (6.8%) | 27/220 (12.3%) | 20/132 (15.2%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pharyngitis streptococcal | 0/44 (0%) | 1/220 (0.5%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pharyngitis | 6/44 (13.6%) | 18/220 (8.2%) | 15/132 (11.4%) | 2/147 (1.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pharyngotonsillitis | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Pneumonia | 0/44 (0%) | 7/220 (3.2%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Respiratory tract infection viral | 2/44 (4.5%) | 3/220 (1.4%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Respiratory tract infection | 0/44 (0%) | 4/220 (1.8%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rhinitis | 3/44 (6.8%) | 8/220 (3.6%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Skin candida | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Tonsillitis | 4/44 (9.1%) | 6/220 (2.7%) | 9/132 (6.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Tracheitis | 1/44 (2.3%) | 1/220 (0.5%) | 5/132 (3.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Upper respiratory tract infection | 6/44 (13.6%) | 58/220 (26.4%) | 34/132 (25.8%) | 3/147 (2%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Urinary tract infection | 0/44 (0%) | 7/220 (3.2%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Varicella | 2/44 (4.5%) | 5/220 (2.3%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral infection | 1/44 (2.3%) | 3/220 (1.4%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral pharyngitis | 2/44 (4.5%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral tonsillitis | 1/44 (2.3%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Viral upper respiratory tract infection | 5/44 (11.4%) | 45/220 (20.5%) | 23/132 (17.4%) | 5/147 (3.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 0/44 (0%) | 3/220 (1.4%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Arthropod sting | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Concussion | 0/44 (0%) | 0/220 (0%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Contusion | 0/44 (0%) | 5/220 (2.3%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Craniocerebral injury | 0/44 (0%) | 0/220 (0%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Excoriation | 1/44 (2.3%) | 0/220 (0%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Face injury | 0/44 (0%) | 0/220 (0%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Fall | 2/44 (4.5%) | 5/220 (2.3%) | 7/132 (5.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Hand fracture | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Laceration | 1/44 (2.3%) | 4/220 (1.8%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Lip injury | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite (loss of appetite) | 22/44 (50%) | 142/220 (64.5%) | 50/132 (37.9%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Decreased appetite | 1/44 (2.3%) | 1/220 (0.5%) | 2/132 (1.5%) | 2/147 (1.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Synovitis | 0/44 (0%) | 0/220 (0%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Arthralgia | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 15/147 (10.2%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Myalgia | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 24/147 (16.3%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Somnolence (drowsiness) | 23/44 (52.3%) | 127/220 (57.7%) | 40/132 (30.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Somnolence | 0/44 (0%) | 3/220 (1.4%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Headache | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | 28/147 (19%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Irritability | 5/44 (11.4%) | 21/220 (9.5%) | 5/132 (3.8%) | 2/147 (1.4%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Irritability | 31/44 (70.5%) | 176/220 (80%) | 69/132 (52.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 1/44 (2.3%) | 8/220 (3.6%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rhinitis allergic | 1/44 (2.3%) | 2/220 (0.9%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rhinorrhoea | 2/44 (4.5%) | 11/220 (5%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dermatitis allergic | 1/44 (2.3%) | 4/220 (1.8%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Dermatitis contact | 0/44 (0%) | 4/220 (1.8%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Dermatitis diaper | 0/44 (0%) | 3/220 (1.4%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Eczema | 0/44 (0%) | 4/220 (1.8%) | 4/132 (3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Miliaria | 1/44 (2.3%) | 1/220 (0.5%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rash generalised | 1/44 (2.3%) | 0/220 (0%) | 0/132 (0%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Rash | 0/44 (0%) | 3/220 (1.4%) | 1/132 (0.8%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Urticaria | 0/44 (0%) | 4/220 (1.8%) | 2/132 (1.5%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
| Dermatitis | 0/44 (0%) | 3/220 (1.4%) | 3/132 (2.3%) | 0/147 (0%) | 0/44 (0%) | 0/220 (0%) | 0/132 (0%) | |||||||
Limitations/Caveats
The immunogenicity data at 36 and 48 months after vaccination 3 was not collected due to change in planned analysis as per latest protocol amendment, according to which blood draw of participants at 36 and 48 months after Vaccination 3 was removed.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02534935
Other Study ID Numbers:
- B1971035
- 2011-004400-38
First Posted:
Aug 28, 2015
Last Update Posted:
Sep 27, 2021
Last Verified:
Aug 1, 2021