Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235949

Enrollment

850

Registered

2010-11-08

Start date

2010-11-12

Completion date

2012-12-08

Last updated

2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Streptococcal

Keywords

Pneumococcal vaccine, Immunogenicity, Safety, Fever, Primary vaccination, Booster vaccination, Pneumococcal disease, Prophylactic antipyretic

Brief summary

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age. In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

Interventions

BIOLOGICALGSK1024850A (SynflorixTM)

Intramuscular injection, 4 doses

BIOLOGICALInfanrix hexa

Intramuscular injection, 3 doses

BIOLOGICALInfanrix-IPV/Hib

Intramuscular injection, 1 dose

DRUGIbuprofen

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

DRUGParacetamol

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Weeks to 16 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria

* Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (. * Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period. * Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations. * History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease. * History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol. * History of any seizures or progressive neurological disease. * Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination . * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period. * Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC). * Any contraindication to treatment with paracetamol as described in the paracetamol SPC. * Body weight \< 5 kg at the time of enrolment. * Child in care.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	One month after primary immunization (At Month 3)	Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
Antibody Concentrations Against Vaccine Pneumococcal Serotypes	One month after primary immunization (At Month 3)	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Antibody Concentrations Against Protein D (Anti-PD)	One month after primary immunization (At Month 3)	Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.

Secondary

Measure	Time frame	Description
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	One month after primary immunization (At Month 3)	Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses	Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses	Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs)	During the entire study period (Month 0 to 10)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	Within 31-days (Day 0-30) following each primary vaccination dose	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Prior to (Month 9) and one month after booster vaccination (Month 10)	Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	One month after primary immunization (Month 3)	OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.
Antibody Concentrations Against Protein D (Anti-PD)	Prior to (Month 9) and one month after booster vaccination (Month 10)	Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	One month after primary immunization (Month 3)	Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Prior to (Month 9) and one month after booster vaccination (Month 10)	Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	One month after primary immunization (Month 3)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	One month after primary immunization (Month 3)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Antibody Concentrations Against Hepatitis B Surface Antigen	Prior to (Month 9) and one month after booster vaccination (Month 10)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	One month after primary immunization (Month 3)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.
Antibody Titers Against Poliovirus Type 1, 2 and 3	One month after primary immunization (Month 3)	Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Countries

Romania

Participant flow

Recruitment details

Among the 850 subjects enrolled in the study, 35 subjects were excluded for lack of confidence in the integrity of the data and 3 subjects were allocated with subject number but didn't receive any vaccination.

Pre-assignment details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participants by arm

Arm	Count
IIBU Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.	198
DIBU Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	198
NIBU Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	199
IPARA Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	71
DPARA Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	72
NPARA Group Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	74
IIBU-IIBU Group 1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	64
IIBU-DIBU Group 1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	60
IIBU-NIBU Group 1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63
DIBU-IIBU Group 1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63
DIBU-DIBU Group 1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63
DIBU-NIBU Group 1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63
NIBU-IIBU Group 1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63
NIBU-DIBU Group 1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	65
NIBU-NIBU Group 1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	62
IPARA-NPARA Group Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	67
DPARA-IPARA Group Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	68
NPARA-IPARA Group Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	67
Total	1,580

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG007	FG008	FG009	FG010	FG011	FG012	FG014	FG015	FG017
Booster Phase	Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Booster Phase	Lost to Follow-up	0	0	0	0	0	0	0	1	1	1	1	0	0	0	1
Booster Phase	Migrated/moved from study area	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1
Booster Phase	Withdrawal by Subject	0	0	0	0	0	0	1	1	0	1	1	2	2	0	0
Primary Phase	Adverse Event	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Primary Phase	Lost to Follow-up	0	0	1	1	0	2	0	0	0	0	0	0	0	0	0
Primary Phase	Migrated/moved from study area	1	1	0	0	1	2	0	0	0	0	0	0	0	0	0
Primary Phase	Withdrawal by Subject	3	2	2	0	0	3	0	0	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	DIBU Group	NIBU Group	IPARA Group	DPARA Group	NPARA Group	Total	IIBU-IIBU Group	IIBU-DIBU Group	IIBU-NIBU Group	DIBU-IIBU Group	DIBU-DIBU Group	DIBU-NIBU Group	NIBU-IIBU Group	IIBU Group	NIBU-DIBU Group	NIBU-NIBU Group	IPARA-NPARA Group	DPARA-IPARA Group	NPARA-IPARA Group
Age, Continuous	13 Weeks STANDARD_DEVIATION 1.2	12.9 Weeks STANDARD_DEVIATION 1.14	13 Weeks STANDARD_DEVIATION 1.3	13.2 Weeks STANDARD_DEVIATION 1.3	13.2 Weeks STANDARD_DEVIATION 1.11	12.3 Months STANDARD_DEVIATION 0.61	12.3 Months STANDARD_DEVIATION 0.64	12.2 Months STANDARD_DEVIATION 0.49	12.3 Months STANDARD_DEVIATION 0.57	12.2 Months STANDARD_DEVIATION 0.45	12.4 Months STANDARD_DEVIATION 0.63	12.4 Months STANDARD_DEVIATION 0.73	12.3 Months STANDARD_DEVIATION 0.63	13.1 Weeks STANDARD_DEVIATION 1.15	12.3 Months STANDARD_DEVIATION 0.57	12.3 Months STANDARD_DEVIATION 0.7	12.3 Months STANDARD_DEVIATION 0.73	12.3 Months STANDARD_DEVIATION 0.56	12.4 Months STANDARD_DEVIATION 0.63
Race/Ethnicity, Customized Not specified	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White- Caucasian/European heritage	197 Participants	198 Participants	70 Participants	72 Participants	72 Participants	765 Participants	64 Participants	60 Participants	63 Participants	63 Participants	63 Participants	62 Participants	63 Participants	198 Participants	65 Participants	62 Participants	66 Participants	68 Participants	66 Participants
Sex: Female, Male Female	86 Participants	104 Participants	39 Participants	40 Participants	38 Participants	379 Participants	29 Participants	27 Participants	29 Participants	23 Participants	33 Participants	27 Participants	32 Participants	90 Participants	35 Participants	35 Participants	37 Participants	39 Participants	33 Participants
Sex: Female, Male Male	112 Participants	95 Participants	32 Participants	32 Participants	36 Participants	415 Participants	35 Participants	33 Participants	34 Participants	40 Participants	30 Participants	36 Participants	31 Participants	108 Participants	30 Participants	27 Participants	30 Participants	29 Participants	34 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	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk
deaths Total, all-cause mortality	0 / 198	0 / 198	0 / 199	0 / 71	0 / 72	0 / 74	0 / 64	0 / 60	0 / 63	0 / 63	0 / 63	0 / 63	0 / 63	0 / 65	0 / 62	0 / 67	0 / 68	0 / 67
other Total, other adverse events	181 / 198	171 / 198	186 / 199	60 / 71	61 / 72	73 / 74	44 / 64	41 / 60	34 / 63	43 / 63	41 / 63	42 / 63	50 / 63	51 / 65	45 / 62	43 / 67	45 / 68	45 / 67
serious Total, serious adverse events	4 / 198	4 / 198	2 / 199	4 / 71	1 / 72	0 / 74	0 / 64	1 / 60	0 / 63	0 / 63	0 / 63	0 / 63	0 / 63	1 / 65	0 / 62	1 / 67	0 / 68	0 / 67

Outcome results

Primary

Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.

Time frame: One month after primary immunization (At Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Arm	Measure	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	1461.3 EL.U/mL
DIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	1353.1 EL.U/mL
NIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	1557.7 EL.U/mL
IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	1109.6 EL.U/mL
DPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	1348.6 EL.U/mL
NPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	1667.9 EL.U/mL

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.99.8% CI: [0.69, 1.28]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.99.8% CI: [0.64, 1.17]

Primary

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: One month after primary immunization (At Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.67 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	2.93 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	1.04 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	6.11 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	3.85 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	4.76 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	2.25 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.82 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	2.1 µg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.87 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	2.21 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.71 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	2.39 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.76 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.83 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	2.01 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	4.52 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	3.8 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	5.04 µg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	0.92 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.6 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	4.34 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.9 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.77 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	2.77 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	2.21 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	2.18 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	4.96 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	1.07 µg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	4.77 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	3.44 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	3.08 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	1.57 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	0.77 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	4.95 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.32 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	1.67 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.18 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.49 µg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	1.95 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	4.12 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.42 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.45 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	1.82 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.38 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	4.08 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	0.74 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	5.2 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	2.36 µg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	1.95 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V	2.4 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F	1 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4	2.59 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5	3.05 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F	2.95 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14	5.17 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B	0.72 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C	4.96 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1	1.95 µg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F	6.98 µg/mL

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.99.8% CI: [0.71, 1.29]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.99.8% CI: [0.77, 1.35]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.99.8% CI: [0.8, 1.41]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.99.8% CI: [0.72, 1.74]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.99.8% CI: [0.79, 1.35]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.99.8% CI: [0.7, 1.31]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.99.8% CI: [0.71, 1.4]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.99.8% CI: [0.6, 1.31]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.99.8% CI: [0.87, 1.75]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.99.8% CI: [0.66, 1.44]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.99.8% CI: [0.67, 1.21]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.99.8% CI: [0.76, 1.32]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.99.8% CI: [0.66, 1.14]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.99.8% CI: [0.83, 1.97]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.99.8% CI: [0.8, 1.31]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.99.8% CI: [0.69, 1.22]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.99.8% CI: [0.68, 1.32]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.99.8% CI: [0.6, 1.27]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.99.8% CI: [0.72, 1.44]

Comparison: At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.99.8% CI: [0.58, 1.27]

Primary

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).

Time frame: One month after primary immunization (At Month 3)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	121 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	143 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	136 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	145 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	143 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	144 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	145 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	144 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	144 Participants
IIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	153 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	155 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	155 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	154 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	135 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	157 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	153 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	153 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	153 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	152 Participants
DIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	141 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	133 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	155 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	160 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	164 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	156 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	158 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	155 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	157 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	149 Participants
NIBU Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	154 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	53 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	52 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	53 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	47 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	53 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	52 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	53 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	55 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	42 Participants
IPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	53 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	37 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	55 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	43 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	50 Participants
DPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	51 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-9V	53 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-23F	50 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-4	56 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-5	54 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-7F	56 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-14	53 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-6B	48 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-18C	54 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-1	55 Participants
NPARA Group	Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Anti-19F	54 Participants

Comparison: At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.98.25% CI: [-4.52, 3.17]

Comparison: At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.98.25% CI: [-4.52, 2.91]

Secondary

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

Time frame: One month after primary immunization (At Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.23 μg/mL
IIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.17 μg/mL
DIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.2 μg/mL
DIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.18 μg/mL
NIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.16 μg/mL
NIBU Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.15 μg/mL
IPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.15 μg/mL
IPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.11 μg/mL
DPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.17 μg/mL
DPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.12 μg/mL
NPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-19A	0.25 μg/mL
NPARA Group	Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-6A	0.19 μg/mL

Secondary

Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	7.492 IU/mL
IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.838 IU/mL
IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.736 IU/mL
IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	8.03 IU/mL
DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	6.887 IU/mL
DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	5.257 IU/mL
DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.593 IU/mL
DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.735 IU/mL
NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	7.57 IU/mL
NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.66 IU/mL
NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.616 IU/mL
NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.283 IU/mL
IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	5.926 IU/mL
IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.681 IU/mL
IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.55 IU/mL
IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.092 IU/mL
DPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.581 IU/mL
DPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.868 IU/mL
DPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	5.831 IU/mL
DPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.269 IU/mL
NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.692 IU/mL
NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	6.486 IU/mL
NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	6.522 IU/mL
NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.628 IU/mL
NIBU-IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.843 IU/mL
NIBU-IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.714 IU/mL
NIBU-IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.095 IU/mL
NIBU-IIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	7.059 IU/mL
NIBU-DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	10.8 IU/mL
NIBU-DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.627 IU/mL
NIBU-DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.883 IU/mL
NIBU-DIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	7.226 IU/mL
NIBU-NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	9.045 IU/mL
NIBU-NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.656 IU/mL
NIBU-NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.858 IU/mL
NIBU-NIBU Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	8.206 IU/mL
IPARA-NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.665 IU/mL
IPARA-NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	6.491 IU/mL
IPARA-NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.666 IU/mL
IPARA-NPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	7.238 IU/mL
DPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.546 IU/mL
DPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.431 IU/mL
DPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	6.477 IU/mL
DPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.698 IU/mL
NPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M9	0.9 IU/mL
NPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M10	6.749 IU/mL
NPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-T, M10	7.423 IU/mL
NPARA-IPARA Group	Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D, M9	0.642 IU/mL

Secondary

Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

Time frame: One month after primary immunization (Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	3.326 IU/mL
IIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	3.746 IU/mL
DIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	2.938 IU/mL
DIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	3.373 IU/mL
NIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	3.961 IU/mL
NIBU Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	3.132 IU/mL
IPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	3.062 IU/mL
IPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	2.943 IU/mL
DPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	2.891 IU/mL
DPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	3.058 IU/mL
NPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-T	3.762 IU/mL
NPARA Group	Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D	3.457 IU/mL

Secondary

Antibody Concentrations Against Hepatitis B Surface Antigen

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	1949.42 mIU/mL
IIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	197.46 mIU/mL
DIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	1898.54 mIU/mL
DIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	210.32 mIU/mL
NIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	1970.6 mIU/mL
NIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	164.33 mIU/mL
IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	1685.87 mIU/mL
IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	136.53 mIU/mL
DPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	225.01 mIU/mL
DPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2492.42 mIU/mL
NPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	194.51 mIU/mL
NPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2107.75 mIU/mL
NIBU-IIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	1851.22 mIU/mL
NIBU-IIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	226.1 mIU/mL
NIBU-DIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2579.59 mIU/mL
NIBU-DIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	244.52 mIU/mL
NIBU-NIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	3244.33 mIU/mL
NIBU-NIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	159.79 mIU/mL
IPARA-NPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2078.63 mIU/mL
IPARA-NPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	128.12 mIU/mL
DPARA-IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	199.57 mIU/mL
DPARA-IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2003.09 mIU/mL
NPARA-IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M9	209.27 mIU/mL
NPARA-IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen	Anti-HBs, M10	2218.23 mIU/mL

Secondary

Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

Time frame: One month after primary immunization (Month 3)

Arm	Measure	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	911.85 mIU/mL
DIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	1139.1 mIU/mL
NIBU Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	1245.07 mIU/mL
IPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	934.65 mIU/mL
DPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	674.25 mIU/mL
NPARA Group	Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	1027.79 mIU/mL

Secondary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	15.7 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	73.8 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	13.3 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	218.6 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	46.1 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	308.8 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	12.8 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	173.5 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	64.4 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	252.7 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	42.6 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	16 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	327.2 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	225.9 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	42.6 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	56.6 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	10.5 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	18.3 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	72.3 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	14.7 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	53.8 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	262.9 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	359.8 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	22.4 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	59.3 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	14.2 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	75.5 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	322.9 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	246.2 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	25.1 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	184.3 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	74.8 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	57.7 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	332.7 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	16 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	13.6 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	63.4 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	57.9 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	226.7 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	19.4 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	312.3 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	12.8 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	255.7 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	338.6 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	12 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	45.7 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	18.8 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	74.9 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	97.6 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	330.4 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	15.2 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	27.3 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	442.8 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	59.1 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	321 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	20.1 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	50.8 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	205.1 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	59.4 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	13 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	66.8 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	332.9 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	48.5 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	19.7 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	10.8 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	214.2 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M10	294.2 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M10	213.6 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M10	57 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA, M9	52.9 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN, M9	20.3 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT, M9	14.2 EL.U/mL

Secondary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Time frame: One month after primary immunization (Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	163.1 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	59.1 EL.U/mL
IIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	103.9 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	171.6 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	64.2 EL.U/mL
DIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	114.3 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	191.1 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	65 EL.U/mL
NIBU Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	118.1 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	171 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	60.4 EL.U/mL
IPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	97.1 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	196.5 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	63.1 EL.U/mL
DPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	106.2 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PT	61.5 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-PRN	114 EL.U/mL
NPARA Group	Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Anti-FHA	168.9 EL.U/mL

Secondary

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

Time frame: One month after primary immunization (Month 3)

Arm	Measure	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	3.994 µg/mL
DIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	3.66 µg/mL
NIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	4.51 µg/mL
IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	3.29 µg/mL
DPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	4.23 µg/mL
NPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	5.007 µg/mL

Secondary

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.878 µg/mL
IIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	21.964 µg/mL
DIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	17.484 µg/mL
DIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.684 µg/mL
NIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.678 µg/mL
NIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	21.277 µg/mL
IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	20.28 µg/mL
IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.824 µg/mL
DPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	18.987 µg/mL
DPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.847 µg/mL
NPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.763 µg/mL
NPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	17.544 µg/mL
NIBU-IIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.798 µg/mL
NIBU-IIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	20.659 µg/mL
NIBU-DIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.72 µg/mL
NIBU-DIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	33.45 µg/mL
NIBU-NIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	22.083 µg/mL
NIBU-NIBU Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	1.013 µg/mL
IPARA-NPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	16.682 µg/mL
IPARA-NPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.696 µg/mL
DPARA-IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.651 µg/mL
DPARA-IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	21.602 µg/mL
NPARA-IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M10	23.277 µg/mL
NPARA-IPARA Group	Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Anti-PRP, M9	0.953 µg/mL

Secondary

Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	661.6 EL.U/mL
IIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	2069 EL.U/mL
DIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1980.1 EL.U/mL
DIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	660.4 EL.U/mL
NIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1907.5 EL.U/mL
NIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	588.3 EL.U/mL
IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	622.9 EL.U/mL
IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1888.7 EL.U/mL
DPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	590 EL.U/mL
DPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1664.8 EL.U/mL
NPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	502 EL.U/mL
NPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1540.7 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	752.1 EL.U/mL
NIBU-IIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	2319.7 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1953.1 EL.U/mL
NIBU-DIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	555.1 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	777.2 EL.U/mL
NIBU-NIBU Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	2285.5 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1482.7 EL.U/mL
IPARA-NPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	446.1 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	525.4 EL.U/mL
DPARA-IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	1517.3 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD, M9	691.3 EL.U/mL
NPARA-IPARA Group	Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD M10	2082.5 EL.U/mL

Secondary

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	1.11 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.33 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.94 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.63 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.75 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.09 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.28 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.87 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	4.5 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	4.46 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.76 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.98 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.41 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	1.07 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.65 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.31 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.72 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	6.02 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	9.35 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	5.75 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	6.9 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.71 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.13 μg/mL
IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	1.36 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.64 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.83 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.83 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.2 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.65 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	1.97 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.86 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	8.06 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	6.64 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.44 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.3 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.03 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.23 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	1.1 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	5.62 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.63 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.23 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.9 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.08 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.18 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.74 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.66 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.36 μg/mL
DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	0.96 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	0.96 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.94 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.22 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.22 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.06 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.83 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.2 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	5.16 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	0.89 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.43 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	7.78 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	1.05 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.54 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.72 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	1.14 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	6.91 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.25 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.41 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.27 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	4.11 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.39 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.59 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.76 μg/mL
NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.55 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.63 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.93 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.08 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.08 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.55 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.35 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.26 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.89 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	4.54 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.96 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.05 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.31 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.38 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	1.03 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.42 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.47 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.24 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.78 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	8.23 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.69 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.55 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.13 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.75 μg/mL
IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.58 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	1.09 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.44 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	7.16 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.72 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	1.03 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.1 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.54 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.76 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.27 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	5.08 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.32 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.18 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.16 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.2 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.1 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.33 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.36 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.66 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.5 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.7 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.16 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.63 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.62 μg/mL
DPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.42 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	4.61 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.07 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.73 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.03 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	7.1 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.38 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.57 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.34 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	1.87 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.65 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.64 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.41 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.7 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.37 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.74 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.32 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.74 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.6 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	1.52 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.09 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	3.93 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.93 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.24 μg/mL
NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.95 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.25 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	6.03 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.84 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	4.21 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	1.09 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.26 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.12 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.16 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.24 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.67 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.04 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	5.43 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.83 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	4.07 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	7.15 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.61 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.56 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.15 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.07 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.6 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.72 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	1.03 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.12 μg/mL
NIBU-IIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.44 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.31 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.92 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	6.56 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	5.55 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.93 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.38 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.73 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.92 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.17 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.69 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	7.26 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.28 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	3.04 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.7 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.2 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.08 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.99 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	11.29 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.58 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.88 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.39 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.32 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.84 μg/mL
NIBU-DIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.93 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.9 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.51 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.43 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	8.68 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.93 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	1.11 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.97 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	4.05 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.23 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	1.4 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.07 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.62 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.28 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.95 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	7.34 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	6.3 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.33 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	1.09 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.96 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.67 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.34 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.58 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.84 μg/mL
NIBU-NIBU Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	4.48 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.27 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.52 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.21 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.56 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	1.74 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	6.18 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.47 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.81 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	0.84 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.74 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.11 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	2.62 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	3.89 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.43 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.31 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	0.91 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.5 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	4.72 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	1.76 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.94 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.18 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.74 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.59 μg/mL
IPARA-NPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.19 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	0.63 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.43 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.14 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.3 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.72 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.93 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	2.53 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	5.54 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.22 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.51 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	3.58 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	8.66 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.87 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.43 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.14 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	1.84 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	5.52 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	0.98 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.53 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.63 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.49 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.19 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.6 μg/mL
DPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	3.31 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F, M9	0.97 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14 M10	5.62 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B M10	2.29 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M9	1.31 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6B, M9	0.61 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A M10	0.98 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M10	1.11 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-18C M10	8.17 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M10	4.33 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M9	1.72 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M10	2.84 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M9	0.84 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-4, M10	4.28 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-6A, M9	0.24 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M10	3.15 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19F M10	6.66 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-5, M9	0.85 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-19A M9	0.24 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V, M9	0.97 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-1, M9	0.45 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-9V M10	3.9 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-23F M9	0.52 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-7F M10	4.52 μg/mL
NPARA-IPARA Group	Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-14, M9	1.86 μg/mL

Secondary

Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1949 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	861 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	72 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	120.8 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1378.2 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	56 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1217.7 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	60.8 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	790.7 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	1724.5 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	85.9 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	86 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	127.8 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	429.9 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	48.3 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	80.9 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	548.7 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	359.5 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	205.4 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	145.7 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	292.1 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1824.5 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	2151.9 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	3649.1 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	588.1 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	388 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	41.7 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	45.4 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	512.5 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	45.3 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	32.1 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	45.2 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	542.4 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	1152.5 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	543.9 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	8 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	134.8 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	67.1 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	558.3 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1217.7 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	70 Titers
NIBU-IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1217.7 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	119.6 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	53.7 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	4 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	724.1 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	139.6 Titers
NIBU-DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	434.1 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1393.4 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1075.9 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	156.1 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	141.2 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	128 Titers
NIBU-NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	2233.3 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	29.7 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	53.8 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	2195 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1290.1 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	2047.9 Titers
IPARA-NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	96.5 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	1625.4 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	139.6 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1625.4 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	108.1 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	1448.1 Titers
DPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	128.3 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M10	861.1 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M9	168.9 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1, M9	117.4 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2, M10	1116.6 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M9	69.7 Titers
NPARA-IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3, M10	2048 Titers

Secondary

Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Time frame: One month after primary immunization (Month 3)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	362 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	283.4 Titers
IIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	423.2 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	327.4 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	351.3 Titers
DIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	252.5 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	624.1 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	337 Titers
NIBU Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	378 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	225.6 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	284 Titers
IPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	240.7 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	394.8 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	394.8 Titers
DPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	166 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 1	449.3 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 3	438.6 Titers
NPARA Group	Antibody Titers Against Poliovirus Type 1, 2 and 3	Anti-Polio 2	335.2 Titers

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

Time frame: Within the 4-day (Days 0-3) period following booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	25 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	16 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	0 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	27 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	16 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	22 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	25 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	3 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	1 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	17 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	9 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	15 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	22 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	2 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	16 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	16 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	15 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	6 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	1 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	11 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	25 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	22 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	28 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	4 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	16 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	3 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
NIBU-IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	18 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	25 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	2 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	1 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	5 Participants
NIBU-DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	32 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	28 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	15 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
NIBU-NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	4 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	4 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	17 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	23 Participants
IPARA-NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	24 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	4 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	0 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants
DPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	12 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness	23 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling	16 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain	24 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain	1 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness	2 Participants
NPARA-IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling	0 Participants

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	60 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	3 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	74 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	29 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	44 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	73 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	31 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	50 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	2 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	70 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	2 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	36 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	1 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	92 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	5 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	108 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	4 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	61 Participants
IIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	3 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	22 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	48 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	51 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	3 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	2 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	63 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	49 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	89 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	2 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	59 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	52 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	48 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	7 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	33 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	76 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	0 Participants
DIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	32 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	1 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	107 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	52 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	105 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	72 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	56 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	30 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	31 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	4 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	15 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	57 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	67 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	1 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	77 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	0 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	6 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	28 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	8 Participants
NIBU Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	78 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	10 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	1 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	19 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	2 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	24 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	10 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	1 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	18 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	1 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	28 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	20 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	16 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	0 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	30 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	5 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	2 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	24 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	21 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	36 Participants
IPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	11 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	23 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	2 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	2 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	37 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	7 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	19 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	12 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	28 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	35 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	0 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	25 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	3 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	22 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	21 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	1 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	2 Participants
DPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	17 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 3	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 2	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 3	13 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Across doses	19 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Across doses	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 2	12 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Across doses	46 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 3	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Across doses	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 1	32 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Across doses	44 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 2	2 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Across doses	7 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 2	31 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 2	1 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling, Dose 1	11 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 1	7 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 2	25 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness, Dose 1	0 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain, Dose 3	1 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 3	22 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain, Dose 1	33 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness, Dose 3	27 Participants
NPARA Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling, Dose 1	0 Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: Within the 4-day (Days 0-3) period following booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	20 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	18 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	14 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	11 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	1 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	22 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	33 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	15 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	22 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	18 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	16 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	17 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	13 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	18 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	27 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	21 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	11 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	4 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	1 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	13 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	15 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	23 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	13 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	12 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	17 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	9 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	19 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	17 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	13 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	19 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	22 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	9 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	12 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	13 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	15 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	18 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	19 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	15 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	9 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	20 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	9 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	26 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	19 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	21 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	23 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	27 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	18 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	20 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	17 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	17 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	17 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	22 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	36 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	27 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	21 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	3 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	19 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	20 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
NIBU-IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	18 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	19 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	26 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	0 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	33 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	18 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	19 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	23 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	24 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
NIBU-DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	24 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	2 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	32 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	28 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	14 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	21 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	24 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	24 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	12 Participants
NIBU-NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	27 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	18 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	2 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	8 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	26 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	18 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	21 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	1 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	12 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	10 Participants
IPARA-NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	9 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	20 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	6 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	13 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	22 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	3 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	13 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	10 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	1 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	16 Participants
DPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	14 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	16 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss of appetite	0 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss of appetite	13 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness	0 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness	19 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss of appetite	17 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness	16 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability	0 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability	27 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability	16 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever	18 Participants
NPARA-IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever	0 Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	121 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	86 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	46 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	3 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	26 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	71 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	77 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	64 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	42 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	3 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	120 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	81 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	32 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	48 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	58 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	3 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	42 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	6 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	56 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	74 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	56 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	91 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	52 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	51 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	40 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	115 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	1 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	4 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	37 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	90 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	61 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	84 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	38 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	79 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	62 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	2 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	10 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	40 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	76 Participants
IIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	61 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	3 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	66 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	54 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	82 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	56 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	5 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	73 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	35 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	68 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	1 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	12 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	101 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	30 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	121 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	5 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	55 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	3 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	111 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	27 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	41 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	31 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	55 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	58 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	78 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	41 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	49 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	72 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	48 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	50 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	47 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	68 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	35 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	83 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	1 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	3 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	84 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	49 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	0 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	88 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	98 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	41 Participants
DIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	35 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	87 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	100 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	64 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	122 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	101 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	1 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	28 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	69 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	101 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	3 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	65 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	109 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	55 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	6 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	76 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	71 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	43 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	85 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	68 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	63 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	2 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	43 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	89 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	45 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	30 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	77 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	2 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	57 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	42 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	3 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	26 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	42 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	123 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	4 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	5 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	138 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	12 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	104 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	3 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	64 Participants
NIBU Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	47 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	18 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	40 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	10 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	20 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	24 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	8 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	9 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	16 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	7 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	33 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	7 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	18 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	12 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	30 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	18 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	14 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	28 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	26 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	5 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	8 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	16 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	6 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	28 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	4 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	27 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	40 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	12 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	12 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	23 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	11 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	20 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	17 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	11 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	0 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	1 Participants
IPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	3 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	1 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	12 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	10 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	24 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	43 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	8 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	34 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	22 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	5 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	17 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	21 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	1 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	2 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	12 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	28 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	1 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	9 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	31 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	15 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	7 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	8 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	11 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	5 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	33 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	18 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	22 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	27 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	16 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	7 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	4 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	11 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	1 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	11 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	28 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	19 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	8 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	16 Participants
DPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	15 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Across doses	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 3	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 2	15 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 1	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 1	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Across doses	40 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 2	25 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 3	29 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Across doses	32 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 2	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 3	11 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 3	14 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Drowsiness, Dose 1	24 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Across doses	30 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Across doses	42 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Across doses	40 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Dose 3	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 2	19 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Across doses	4 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 2	22 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 1	43 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Across doses	59 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 1	20 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 1	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 1	23 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 3	16 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Across doses	31 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 3	12 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Irritability, Dose 2	37 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Loss appetite, Dose 2	14 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Drowsiness, Across doses	2 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 2	24 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 1	27 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever, Dose 1	30 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 3	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 2	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever, Dose 3	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 2	1 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Dose 2	0 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 3	16 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Loss appetite, Dose 1	32 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever, Dose 3	12 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Irritability, Dose 1	3 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 1	36 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Irritability, Dose 3	17 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Loss appetite, Across doses	2 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Dose 2	25 Participants
NPARA Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Drowsiness, Across doses	45 Participants

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.

Time frame: During the entire study period (Month 0 to 10)

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any Serious Adverse Events (SAEs)	4 Participants
DIBU Group	Number of Subjects With Any Serious Adverse Events (SAEs)	4 Participants
NIBU Group	Number of Subjects With Any Serious Adverse Events (SAEs)	2 Participants
IPARA Group	Number of Subjects With Any Serious Adverse Events (SAEs)	4 Participants
DPARA Group	Number of Subjects With Any Serious Adverse Events (SAEs)	1 Participants
NPARA Group	Number of Subjects With Any Serious Adverse Events (SAEs)	0 Participants

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Time frame: Within 31-days (Day 0-30) following each primary vaccination dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
IIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	28 Participants
DIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	33 Participants
NIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	35 Participants
IPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	16 Participants
DPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	4 Participants
NPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	13 Participants

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

Time frame: Within 31-days (Day 0-30) following booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.

Arm	Measure	Value (NUMBER)
IIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	6 Subjects
DIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	6 Subjects
NIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	2 Subjects
IPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	3 Subjects
DPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	3 Subjects
NPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	4 Subjects
NIBU-IIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	6 Subjects
NIBU-DIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	6 Subjects
NIBU-NIBU Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	3 Subjects
IPARA-NPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	4 Subjects
DPARA-IPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	0 Subjects
NPARA-IPARA Group	Number of Subjects With Any Unsolicited Adverse Events (AEs)	2 Subjects

Secondary

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value 99999.9 has been entered when value to be entered in the system was greater than (\>) 1.0 E10.

Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	912.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	830 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	5.8 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	16259.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	183.7 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	7.2 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	96.1 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	745.6 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	1112.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	27.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	1592.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	346.2 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	149.2 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	131.8 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	928.1 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	581 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	363.7 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	34 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	4969 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	2076 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	12.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	63 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	39.8 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	45.1 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	330.5 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	237.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	7.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	865.8 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	4591.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	125.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	80.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1283.8 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1777.3 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	7041.7 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	255.1 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	296.3 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	93.3 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	671.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	606.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	132.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	9.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	32.1 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	2381.5 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	207.3 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	2394.7 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1762.5 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	4756.1 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	2213.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	316.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	47.2 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	88.5 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	241.7 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	4426.6 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	2575.2 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	769.1 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	84.3 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	22.2 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	318.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	8.2 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	2792.9 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	13.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	649.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	12162.6 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	21.2 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1729.9 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1302.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	2977.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	11741 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	397.3 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	637.1 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	694.2 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	4190.8 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	9 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	9.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	29.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	158 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	19 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	2096.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	239.5 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	13.3 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	11.5 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	79 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	737.1 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	50.3 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	581.1 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	28 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	1507.6 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	29.8 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	407.6 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1037.5 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	2096.1 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	5343.2 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1423.6 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	3772.9 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	17.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	791.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	553.1 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	134 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	289.4 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	21.9 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	650.6 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	1040.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	114.1 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	2002 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	224.8 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	7.4 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	9941.8 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	17.5 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	74.5 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	50.6 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	248 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1096.7 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	325.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	5744.5 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	165.8 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1081.9 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	169.2 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	344.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	10.9 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	10.8 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	396.6 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	4970.9 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	67.8 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	1575 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	3530.1 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	99 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	208.9 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	9.9 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	74.2 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	1312.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	3522.8 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	298.1 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	539.2 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	1021.6 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	428.6 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	16.4 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	15 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	499.7 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	99.5 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	572.7 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	98.1 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	14362.4 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	295 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1953.4 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	237.6 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	7.6 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	4218.9 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	388.2 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1075.2 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	125.7 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	2563 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	98.1 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	7.3 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	23.3 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	31.9 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	1498.1 Titers
NIBU-IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	4249.1 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	34.1 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	24.2 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	253 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	707.9 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	935.3 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1152 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	13.7 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	546.2 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	255.9 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	3682.7 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	40.2 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	128.9 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	273.9 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	9.4 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	12.7 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1149.8 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	3565.8 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	30.5 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	2919.8 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	106.9 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	282.1 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	52.4 Titers
NIBU-DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	173.1 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	5829.1 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	481.3 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	250.6 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	1464.1 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	1571.3 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	8601.7 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	382.6 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	15.6 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	3817 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	5.5 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	53.2 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	120 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	12.8 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	58.3 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	10.7 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	627 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	15.2 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1414.1 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	9.8 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	184.6 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	182.5 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	1047.8 Titers
NIBU-NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1263.5 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	42.2 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	120.6 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	856.6 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	548.3 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	25.9 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	6.5 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	98.3 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	557.5 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	89.4 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1290.9 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	127.7 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	5.7 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	297 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	11414.1 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	567.4 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	6 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	44.3 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	431.5 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	154 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	46.7 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	11 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	149.9 Titers
IPARA-NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	163.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	7262.2 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	1885.9 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	12.2 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	84 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	9.1 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	7.4 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	416.5 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	42.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	125.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	19.1 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	2288 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	274.5 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	105.6 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	1215.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	260.7 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	904.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	480.9 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	21670 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	159.1 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	888.9 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	2256.2 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	1436.2 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	56.3 Titers
DPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	736.3 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M10	78.5 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A, M9	24.5 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M10	376.5 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M9	738.7 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M10	875.2 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M10	541.6 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M10	7567.3 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M10	887.6 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M9	22.2 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A, M9	4 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M9	161.8 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4, M10	854.4 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M9	48.4 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F, M10	511 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B, M9	239 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F, M9	37.7 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1, M9	15.7 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M9	195.4 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F, M9	1744.7 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14, M10	587.5 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V, M10	1340.1 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M9	14 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5, M10	149.7 Titers
NPARA-IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C, M10	242.7 Titers

Secondary

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.

Time frame: One month after primary immunization (Month 3)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results or antibodies against at least one study vaccine antigen component after vaccination were available.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	86.6 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	186.9 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	3429.2 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	1346.3 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	1311 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	69.4 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	8827.7 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	723 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	16.6 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	79 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	989.8 Titers
IIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	536.2 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	1219.7 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	882.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	4977.9 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	4040.4 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	167.6 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	514.8 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	1105.5 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	151.1 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	46.1 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	67.9 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	1172.3 Titers
DIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	52.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	361.3 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	1296 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	2744.2 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	74.3 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	1417.9 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	1027.7 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	75.9 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	267.9 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	135.9 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	20.4 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	6444.8 Titers
NIBU Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	26.4 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	739.9 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	91.6 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	501.1 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	1188.4 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	8362.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	100.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	38.7 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	11.2 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	23 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	684.8 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	5520.1 Titers
IPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	591.5 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	70.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	254.2 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	1780.5 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	1712.4 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	382.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	94 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	723 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	7306.4 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	3777.1 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	34.2 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	39.7 Titers
DPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	140.3 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19F	272.1 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-18C	106 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-19A	11.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6B	237.1 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-4	777.2 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-1	64.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-5	80.8 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-7F	6286.1 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-23F	838.4 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-9V	2273.2 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-6A	44.5 Titers
NPARA Group	Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPSONO-14	1460.1 Titers

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Antibody Concentrations Against Protein D (Anti-PD)

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids

Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids

Antibody Concentrations Against Hepatitis B Surface Antigen

Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody Concentrations Against Protein D (Anti-PD)

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody Titers Against Poliovirus Type 1, 2 and 3

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects With Any Serious Adverse Events (SAEs)

Number of Subjects With Any Unsolicited Adverse Events (AEs)

Number of Subjects With Any Unsolicited Adverse Events (AEs)

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes