Meningococcal Vaccine
Conditions
Keywords
Meningococcal Vaccine, Invasive Meningococcal Disease, Meningococcal Serogroups A, B, C W and Y, MenABCWY Vaccine
Brief summary
The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.
Interventions
BIOLOGICALMenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
BIOLOGICALBivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine
BIOLOGICALBivalent rLP2086 (120-µg Dose)
Trumenba - Meningococcal Group B vaccine
BIOLOGICALBexsero
Bexsero - Meningococcal Group B vaccine
DRUGProphylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
BIOLOGICALNimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
OTHERPlacebo
Normal Saline
DRUGScheduled Liquid Paracetamol (SLP)
SLP administration after primary vaccinations 1 and 2.
DRUGTherapeutic Liquid Paracetamol (TLP)
TLP administration after primary vaccinations 1 and 2
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Open label for Groups 1-5,7,8,10 and 11, no masking; Groups 13-14 is blinded.
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization. 2. Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone. 4. Healthy participant as determined by medical history, physical examination, and judgment of the investigator. 5. Body weight ≥4 kg for participants 2 months of age at the time of randomization. 6. Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
1. Prior adverse reaction to paracetamol use, including allergic reactions. 2. Participant was born prematurely (\<37 weeks of gestation). 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the SRM for additional details. 6. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. 7. Significant neurological disorder or history of seizure (including simple febrile seizure). 8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 9. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 10. Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization. 11. For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine. 12. Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 13. Receipt of any blood products, including immunoglobulin, before the first study vaccination. 14. Current chronic use of systemic antibiotics. 15. Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 30 minutes after booster vaccination | Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 7 Days after booster vaccination | Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. |
| Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 7 days after booster vaccination | Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C, categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | From date of booster vaccination through 1 month after booster vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | 1 month after primary vaccination 2 | Percentage of participants achieving hSBA titer greater than or equal to (\>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination. |
| Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | 1 month after booster vaccination | Percentage of participants achieving hSBA titer \>= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination. |
| Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | 1 month After primary vaccination 2 | Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination. |
| Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5 | 1 month after primary vaccination 2 | Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. |
| Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | 1 Month after booster vaccination | Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination. |
| Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5 | 1 Month after booster vaccination | Percentage of participants achieving hSBA titer \>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination. |
| Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 7 days after primary vaccination 1 | Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Within 7 Days after primary Vaccination 2 | Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 7 Days after primary Vaccination 1 | Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method |
| Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Within 7 days after primary vaccination 2 | Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 30 days after primary vaccination 1 | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Within 30 days after primary vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Within 30 days after any primary vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | From 1 month after primary vaccination 2 up to booster vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months) | Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age. |
| Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined | Within 30 minutes After primary vaccination 1 | Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. |
| Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined | Within 30 minutes After primary vaccination 2 | Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | Within 30 days after any vaccination | Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age. |
| hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5 | 1 Month after primary Vaccination 2 | GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers. |
| hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5 | 1 month after booster vaccination | GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination. |
| Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Within 7 Days after primary Vaccination(Vac) 1 and 2 | Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure. |
| Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Within 7 Days after primary Vaccination 1 and 2 | Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted. |
Countries
Germany, Greece, Spain
Participant flow
Pre-assignment details
326 participants signed the informed consent form and were enrolled in the study. Out of which 1 participant was not vaccinated as parent withdrew consent. 325 participants received vaccination. The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (MenABCWY +PLP) Infant participants aged 6 months were administered a single intramuscular injection of 0.5 milliliter (mL) Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) into left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Prophylactic liquid paracetamol regimen (PLP) was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination (Day 1 \[primary vaccination {vacc}1\] and Month 2 \[primary vaccination 2\]). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into right thigh on Day 1. | 23 |
| Group 2 (MenABCWY) Infant participants aged 6 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of MenABCWY approximately 6 months after vaccination 1 (booster vaccination). All subjects received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at Day 1. | 25 |
| Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP) Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 microgram \[mcg\]) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP or SLP was administered orally. Participants received a single intramuscular injection of 0.25 mL bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. | 36 |
| Group 4 (60 mcg rLP2086 +Nimenrix) Infant participants aged 2 months were administered a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.25 mL of bivalent rLP2086 (60 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. | 16 |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. | 53 |
| Group 7 (MenABCWY +SLP) Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh. Scheduled liquid paracetamol (SLP) was administered orally at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). Participants received a single intramuscular injection of 0.5 mL MenABCWY approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. No participants received booster dose due to study termination. | 50 |
| Group 8 (Bexsero +Nimenrix +PLP) Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. | 55 |
| Group 10 (Bexsero +Nimenrix) Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of Bexsero into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1), Month 2 (primary vaccination 2) and at approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age. | 55 |
| Group 11 (MenABCWY +TLP) Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL MenABCWY into the left thigh at Day 1 (primary vaccination 1). Therapeutic Liquid Paracetamol regimen (TLP) was administered orally. No participants received Vaccination 2 and booster dose due to study termination. All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 months of age. | 12 |
| Total | 325 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Follow-up Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Vaccination Phase | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Vaccination Phase | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Vaccination Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Vaccination Phase | No longer meets eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Vaccination Phase | Other | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Vaccination Phase | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Vaccination Phase | Study terminated by sponsor | 0 | 0 | 14 | 15 | 47 | 43 | 29 | 29 | 12 |
| Vaccination Phase | Withdrawal by parent/guardian | 0 | 0 | 2 | 1 | 3 | 4 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Group 1 (MenABCWY +PLP) | Group 2 (MenABCWY) | Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP) | Group 4 (60 mcg rLP2086 +Nimenrix) | Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Group 7 (MenABCWY +SLP) | Group 8 (Bexsero +Nimenrix +PLP) | Group 10 (Bexsero +Nimenrix) | Group 11 (MenABCWY +TLP) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 158.5 Days STANDARD_DEVIATION 6.87 | 161.6 Days STANDARD_DEVIATION 14.45 | 71.1 Days STANDARD_DEVIATION 7 | 67.6 Days STANDARD_DEVIATION 5.81 | 68.9 Days STANDARD_DEVIATION 6.39 | 68.0 Days STANDARD_DEVIATION 5.99 | 67.4 Days STANDARD_DEVIATION 7.89 | 67.5 Days STANDARD_DEVIATION 7.3 | 69.4 Days STANDARD_DEVIATION 7.69 | 81.9 Days STANDARD_DEVIATION 33.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 9 Participants | 21 Participants | 8 Participants | 10 Participants | 25 Participants | 18 Participants | 22 Participants | 6 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 16 Participants | 15 Participants | 8 Participants | 43 Participants | 25 Participants | 37 Participants | 33 Participants | 6 Participants | 193 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 24 Participants | 35 Participants | 16 Participants | 52 Participants | 50 Participants | 55 Participants | 55 Participants | 12 Participants | 319 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 21 Participants | 7 Participants | 24 Participants | 27 Participants | 32 Participants | 20 Participants | 7 Participants | 160 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 15 Participants | 9 Participants | 29 Participants | 23 Participants | 23 Participants | 35 Participants | 5 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 | 0 / 36 | 0 / 16 | 0 / 53 | 1 / 50 | 0 / 55 | 0 / 55 | 0 / 12 |
| other Total, other adverse events | 23 / 23 | 25 / 25 | 36 / 36 | 16 / 16 | 53 / 53 | 50 / 50 | 54 / 55 | 55 / 55 | 12 / 12 |
| serious Total, serious adverse events | 0 / 23 | 1 / 25 | 1 / 36 | 1 / 16 | 11 / 53 | 5 / 50 | 1 / 55 | 6 / 55 | 1 / 12 |
Outcome results
Primary
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer \>= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Time frame: 1 month after booster vaccination
Population: Post-booster vaccination EIP: randomized participants eligible through V6;received vaccine at V1, V3, V5;blood drawn for assay testing within required timeframes at V6; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V6; received no prohibited vaccines/treatment and had no protocol deviations through V6. Here, ''N''=participants evaluable for the outcome measure and ''n''=participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenA | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenC | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenW | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenY | 100.0 Percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Time frame: 1 Month after booster vaccination
Population: Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc\[28-42 days\]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here; ''n''=participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB80 (A22) | 25.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB2707 (B44) | 34.1 Percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
Percentage of participants achieving hSBA titer \>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.
Time frame: 1 Month after booster vaccination
Population: Post booster vacc. evaluable immunogenicity population=randomised to study group of interest,eligible through V6. Received investigational products at V1,3,5 as randomised,blood drawn for assay testing at required time frames at V6(1 month after booster vacc\[28-42 days\]).At least 1 valid,determinate MenA, C, W, Y,or B assay result at V6, received no prohibited vaccines/treatment, no protocol deviations through V6.''N''=participants evaluable here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5 | PMB80 (A22) | 38.9 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5 | PMB2707 (B44) | 83.3 Percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.
Time frame: 1 month after primary vaccination 2
Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5 | PMB80 (A22) | 46.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5 | PMB2707 (B44) | 82.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5 | PMB80 (A22) | 47.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5 | PMB2707 (B44) | 97.8 Percentage of participants |
Primary
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Time frame: 1 month After primary vaccination 2
Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB80 (A22) | 44.4 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB2707 (B44) | 88.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB80 (A22) | 9.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | PMB2707 (B44) | 29.5 Percentage of participants |
Primary
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer greater than or equal to (\>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Time frame: 1 month after primary vaccination 2
Population: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenA | 100.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenC | 100.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenW | 100.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenY | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenY | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenA | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenW | 100.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MenC | 100.0 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)
Population: Booster vaccination follow-up safety population included participants who received the booster dose of investigational product and who had safety follow-up between Visit 6 and up to and including Visit 7 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 17.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 2.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 15.2 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From date of booster vaccination through 1 month after booster vaccination
Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 27.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 92 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 1.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 6.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 56.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 43.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 33.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 24.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 1.8 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)
Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 25.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 40.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 2.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Time frame: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 59.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 45.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 1.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 9.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 1.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 40.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 4.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 30.0 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.
Time frame: Within 30 days after any primary vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 40.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 29.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 6.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMC | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 24.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 16.4 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: Within 30 days after primary vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 24.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 14.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMCs | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | NDCMCs | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | AEs | 16.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | MAEs | 10.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | SAEs | 0 Percentage of participants |
Primary
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.
Time frame: Within 30 days after primary vaccination 2
Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | SAEs | 2.4 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | AEs | 33.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | MAEs | 23.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | NDCMC | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | MAEs | 11.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | AEs | 12.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | SAEs | 0 Percentage of participants |
Primary
Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Time frame: Within 30 minutes after booster vaccination
Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | 0 Percentage of participants |
Primary
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Time frame: Within 30 minutes After primary vaccination 1
Population: Primary vaccination 1 safety population included all participants who received the first dose of investigational product at Visit 1 and who had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined | 0 Percentage of participants |
Primary
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Time frame: Within 30 minutes After primary vaccination 2
Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined | 0 Percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.
Time frame: Within 7 Days after booster vaccination
Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness | 38 Participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling | 35 Participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site | 63 Participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after primary vaccination 1
Population: Primary vaccination 1 safety population included all randomised participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Mild | 22.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Moderate | 48.4 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Mild | 22.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Moderate | 11.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Mild | 21.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Moderate | 17.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Moderate | 12.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Moderate | 24.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Mild | 25.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Tenderness at injection site: Severe | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Mild | 22.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Mild | 23.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Swelling: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Redness: Moderate | 6.5 Percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 Days after primary Vaccination 2
Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Moderate | 12.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Mild | 19.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Mild | 22.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Moderate | 34.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Moderate | 14.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Severe | 4.9 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Mild | 26.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Severe | 2.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Mild | 27.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Moderate | 11.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Redness: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Mild | 25.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Moderate | 12.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Swelling: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Mild | 27.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Tenderness at injection site: Moderate | 23.4 Percentage of participants |
Primary
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after primary vaccination 2 up to booster vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | AEs | 17.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | SAEs | 4.9 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | MAEs | 12.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | NDCMC | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | MAEs | 15.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | AEs | 18.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | NDCMC | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined | SAEs | 2.8 Percentage of participants |
Primary
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C, categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Time frame: Within 7 days after booster vaccination
Population: Booster vaccination safety population included participants who received booster dose of investigational product, had safety follow-up between Visit 5 and prior to Visit 6 (after booster vaccination). Here, 'N'=participants evaluable for this outcome measure. Data was not collected from participants in Groups 7 and 11 as no participants received booster vaccination due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: 38.0°C to 38.4°C | 19.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.4°C to 38.9°C | 11.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.9°C to 40.0°C | 4.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Severe | 2.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Mild | 22.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Moderate | 42.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Severe | 7.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Mild | 26.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Moderate | 18.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Severe | 1.1 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Use of antipyretic medication | 63.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Mild | 17.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Moderate | 27.5 Percentage of participants |
Primary
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method
Time frame: Within 7 Days after primary Vaccination 1
Population: Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: 38.0°C to 38.4°C | 29.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.4°C to 38.9°C | 24.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.9°C to 40.0°C | 9.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >40.0°C | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Mild | 17.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Moderate | 43.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Severe | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Mild | 21.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Moderate | 59.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Severe | 14.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Mild | 37.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Moderate | 32.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Severe | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Use of antipyretic medication | 46.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Mild | 39.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: 38.0°C to 38.4°C | 15.7 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Mild | 19.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.4°C to 38.9°C | 5.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Severe | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >38.9°C to 40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Moderate | 45.4 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Fever: >40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Drowsiness: Moderate | 18.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Mild | 17.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Irritability: Severe | 6.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Moderate | 21.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Use of antipyretic medication | 50.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined | Decreased appetite: Severe | 0.9 Percentage of participants |
Primary
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after primary vaccination 2
Population: Primary vaccination 2 safety population included all participants who received the second dose of investigational product at Visit 3 and who had safety follow-up between Visit 3 and prior to Visit 4. Here, ''N''=participants evaluable for this outcome measure. Data was not collected from participants in Group 11 as no participants received primary vaccination 2 due to study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: 38.0°C to 38.4°C | 26.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >38.4°C to 38.9°C | 26.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >38.9°C to 40.0°C | 12.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >40.0°C | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Mild | 22.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Moderate | 31.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Severe | 4.9 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Mild | 12.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Moderate | 53.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Severe | 22.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Mild | 29.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Moderate | 34.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Severe | 4.9 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Use of antipyretic medication | 41.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Mild | 45.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: 38.0°C to 38.4°C | 31.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Mild | 21.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >38.4°C to 38.9°C | 14.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Severe | 0.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >38.9°C to 40.0°C | 2.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Moderate | 48.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Fever: >40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Drowsiness: Moderate | 14.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Mild | 20.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Irritability: Severe | 6.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Moderate | 25.2 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Use of antipyretic medication | 72.9 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined | Decreased appetite: Severe | 3.7 Percentage of participants |
Secondary
hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 Month after primary Vaccination 2
Population: Post-primary vaccination 2 evaluable immunogenicity population: participants randomized to study group of interest; eligible through Visit(V)4; received vaccine at V1,V3;blood drawn for assay testing at required timeframes at V4; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V4;received no prohibited vaccines/treatment,no protocol deviations through V4. Here,''N''= participants evaluable for the outcome measure;''n''= participants evaluable for specific rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 7 and 11 Combined | hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5 | PMB2707 (B44) | 25.0 Titers |
| Group 7 and 11 Combined | hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5 | PMB80 (A22) | 13.9 Titers |
| Group 8 and 10 Combined | hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5 | PMB80 (A22) | 15.3 Titers |
| Group 8 and 10 Combined | hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5 | PMB2707 (B44) | 25.0 Titers |
Secondary
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination.
Time frame: 1 month after booster vaccination
Population: Post-primary vaccination 2 evaluable immunogenicity population:eligible participants randomized through Visit(V)4;received vaccine at V1,V3;blood drawn for assay testing within required timeframes at V4;had at least 1 valid, determinate MenA, C, W, Y, or B assay result at V4;received no prohibited vaccines/treatment;no protocol deviation through V4. Here,''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 7 and 11 Combined | hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5 | PMB80 (A22) | 21.8 Titers | 95% Confidence Interval 11.1 |
| Group 7 and 11 Combined | hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5 | PMB2707 (B44) | 25.4 Titers | 95% Confidence Interval 12.6 |
Secondary
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Time frame: Within 30 days after any vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | MAEs | 47.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | AEs | 52.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | NDCMC | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | SAEs | 2.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | MAEs | 62.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | SAEs | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | AEs | 68.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | NDCMC | 6.3 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | NDCMC | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | AEs | 60.4 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | SAEs | 20.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5 | MAEs | 47.2 Percentage of participants |
Secondary
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure.
Time frame: Within 7 Days after primary Vaccination(Vac) 1 and 2
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Moderate | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Mild | 16.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site:Mild | 19.4 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteSevere | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Mild | 33.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Mild | 19.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vaccination 1:Redness:Mild | 27.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Moderate | 11.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Moderate | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness: Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Moderate | 41.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling Severe | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteModerate | 9.5 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness:Moderate | 8.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.site Mild | 28.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.site Mild | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteModerate | 18.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteSevere | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness:Moderate | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Mild | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vaccination 1:Redness:Mild | 18.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Mild | 18.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Moderate | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Moderate | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site:Mild | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Mild | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Moderate | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Moderate | 18.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling Severe | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Moderate | 5.7 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Severe | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site:Mild | 22.6 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Moderate | 20.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac1Tenderness at inj.site: Severe | 1.9 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Mild | 19.2 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Moderate | 3.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Redness: Severe | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Mild | 9.6 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Swelling: Moderate | 1.9 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness:Moderate | 3.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.site Mild | 32.7 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteModerate | 17.3 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vac2Tenderness at inj.siteSevere | 1.9 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1Redness: Severe | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vacc1:Swelling: Mild | 9.4 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5 | Vaccination 1:Redness:Mild | 13.2 Percentage of participants |
Secondary
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted.
Time frame: Within 7 Days after primary Vaccination 1 and 2
Population: Primary vaccination 1 safety population included all randomized participants who received the first dose of investigational product at Visit 1 and had safety follow-up between Visit 1 and prior to Visit 3. Here, ''N''=participants evaluable for this outcome measure; ''n''= participants evaluable for specific rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilityModerate | 23.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.9°C to 40.0°C | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilitySevere | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilitySevere | 8.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessMild | 47.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessModertae | 23.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessSevere | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessMild | 36.1 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessModerate | 33.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreasedappetite Severe | 2.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.4°C to 38.9°C | 27.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityMild | 16.7 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessSevere | 2.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityModerate | 58.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Use of antipyretic medication | 58.3 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever38.0°C to 38.4°C | 30.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever >40.0°C | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >38.0°C to 38.4°C | 23.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >>38.4°C to 38.9°C | 23.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Mild | 25.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Use of antipyretic medication | 81.0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>>38.9°C to 40.0°C | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>40.0°C | 0 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteMild | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteModerate | 28.6 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Moderate | 22.2 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetite Severe | 4.8 Percentage of participants |
| Group 7 and 11 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 Irritability Mild | 28.6 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteMild | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Use of antipyretic medication | 56.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever38.0°C to 38.4°C | 18.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilitySevere | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >38.0°C to 38.4°C | 25.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever >40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessMild | 43.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilitySevere | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilityModerate | 68.8 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessModertae | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.9°C to 40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >>38.4°C to 38.9°C | 25.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessSevere | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.4°C to 38.9°C | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Use of antipyretic medication | 87.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessMild | 37.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteModerate | 50.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 Irritability Mild | 12.5 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreasedappetite Severe | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityMild | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>>38.9°C to 40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetite Severe | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>40.0°C | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityModerate | 75.0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessSevere | 0 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessModerate | 31.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Mild | 6.3 Percentage of participants |
| Group 8 and 10 Combined | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Moderate | 43.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Use of antipyretic medication | 83.0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever38.0°C to 38.4°C | 35.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.4°C to 38.9°C | 17.0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever>38.9°C to 40.0°C | 11.3 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Fever >40.0°C | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Mild | 28.3 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityModerate | 58.5 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilitySevere | 13.2 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessModerate | 39.6 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessSevere | 3.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >38.0°C to 38.4°C | 28.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 >>38.4°C to 38.9°C | 25.0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>>38.9°C to 40.0°C | 13.5 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2>40.0°C | 0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteMild | 28.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetiteModerate | 38.5 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Decreased appetite Severe | 5.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2 Irritability Mild | 21.2 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilityModerate | 48.1 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2IrritabilitySevere | 9.6 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessMild | 40.4 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessModertae | 28.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2DrowsinessSevere | 3.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac2Use of antipyretic medication | 86.5 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreased appetite Moderate | 34.0 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1Decreasedappetite Severe | 3.8 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1IrritabilityMild | 5.7 Percentage of participants |
| Group 5 (120 mcg rLP2086 +Nimenrix +PLP) | Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5 | Vac1DrowsinessMild | 49.1 Percentage of participants |