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Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398706
Enrollment
852
Registered
2020-05-21
Start date
2020-05-22
Completion date
2023-08-10
Last updated
2025-09-08

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

Conditions

Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type b Immunisation, Polio Immunisation, Measles Immunisation, Rubella Immunisation, Varicella Immunisation, Mumps Immunisation

Brief summary

Primary objectives: * To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) * In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel * In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX\])

Detailed description

For toddlers, the duration of each participant's participation in the study will be approximately 6 months for subjects enrolled in Groups 1, 2, 3, and 4. For infants, the duration of each participant's participation in the study will be approximately 16 to 19 months for subjects enrolled in Groups 5, 6, 7, and 8.

Interventions

BIOLOGICALPneumococcal Conjugate Vaccine formulation 1

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICALPneumococcal Conjugate Vaccine formulation 2

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICALPneumococcal Conjugate Vaccine formulation 3

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICALVaricella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICALMeasles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICALPneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICALRotavirus Vaccine, Live, Oral, Pentavalent

Pharmaceutical form:liquid Route of administration: oral

BIOLOGICALHepatitis B Vaccine* [Recombinant] *as applicable

Pharmaceutical form:liquid Route of administration: intramuscular

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The study will be performed in a modified double-blind fashion: * Investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered * Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered This study will be observer-blinded between any SP0202 formulation and Prevnar 13 and double-blind across the 3 SP0202 formulations

Eligibility

Sex/Gender
ALL
Age
42 Days to 15 Months
Healthy volunteers
Yes

Inclusion criteria

: Toddlers and infants: * Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures * Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 5.5 lbs or 2.5 kg Specifically for toddlers: * Aged 12 to 15 months on the day of the first study visit * Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy Specifically for infants: \- Aged 42 to 89 days on the day of the first study visit

Exclusion criteria

Toddlers and infants * Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated * Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * Active tuberculosis * History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically * History of any neurologic disorder, including any seizures and progressive neurologic disorders * History of Guillain-Barré syndrome * Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances * Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion * Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives * In an emergency setting, or hospitalized involuntarily * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations * Receipt of immune globulins, blood or blood-derived products since birth. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth * Previous vaccination against S. pneumoniae * Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella * Receipt of more than 1 previous dose of hepatitis B vaccine * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease * History of intussusception The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Day 330The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Number of Participants With Immediate Adverse Events (AEs)Up to 30 minutes after each vaccinationAn AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.
Number of Participants With Solicited Injection Site ReactionsUp to 7 days after each vaccinationA solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.
Number of Participants With Solicited Systemic ReactionsUp to 7 days after each vaccinationA solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.
Number of Participants With Unsolicited AEsUp to 30 days after each vaccinationAn AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 daysAn SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseDay 30The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Day 150Percentage of infants with serotype specific IgG concentration \>=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Day 150The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Secondary

MeasureTime frameDescription
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseDay 30The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Day 150The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Day 330The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3Day 150Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Day 150Percentage of participants with toxoid concentration \>=0.10 mcg/mL for diphtheria and tetanus and \>=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Day 150Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer \>=8.
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Day 150Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.
For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3Day 150Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is \>=10 milli international units (mIU).
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Day 330Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations \>=255 mIU/mL, anti-mumps antibody concentrations: \>=10 antibody units/mL, anti-rubella antibody concentrations \>=10 IU/mL and anti-varicella concentrations \>=5 units/mL is reported in this outcome measure.

Countries

Canada, Honduras, Puerto Rico, United States

Participant flow

Recruitment details

The Stage I of study was conducted at 22 active centers in the US between 22 May 2020 and 10 March 2021. The Stage II of study was conducted at 35 active centers in the US, Canada and Honduras between 16 April 2021 and 24 February 2022.

Pre-assignment details

A total of 140 participants were randomized in Stage I and 712 participants were randomized in Stage II of study.

Participants by arm

ArmCount
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
35
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
35
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
35
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
35
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
179
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
178
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
179
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
176
Total852

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyAdverse Event00000110
Overall StudyLost to Follow-up01216382
Overall StudyProtocol deviation01006463
Overall StudyWithdrawal by parent/guardian021219231311

Baseline characteristics

CharacteristicStage I: Group 1 SP0202-IIbStage I: Group 2 SP0202-VIStage I: Group 3 SP0202-VIIStage I: Group 4 Prevnar 13Stage II: Group 5 SP0202-IIbStage II: Group 6 SP0202-VIStage II: Group 7 SP0202-VIIStage II: Group 8 Prevnar 13Total
Age, Continuous1.1 years
STANDARD_DEVIATION 0.11
1.1 years
STANDARD_DEVIATION 0.1
1.1 years
STANDARD_DEVIATION 0.12
1.2 years
STANDARD_DEVIATION 0.11
0.2 years
STANDARD_DEVIATION 0.03
0.2 years
STANDARD_DEVIATION 0.03
0.2 years
STANDARD_DEVIATION 0.03
0.2 years
STANDARD_DEVIATION 0.03
0.3 years
STANDARD_DEVIATION 0.36
Race/Ethnicity, Customized
American Indian or Alaska Native
2 Participants1 Participants0 Participants2 Participants26 Participants26 Participants23 Participants23 Participants103 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants2 Participants2 Participants1 Participants0 Participants0 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Black or African American
5 Participants2 Participants3 Participants6 Participants10 Participants17 Participants10 Participants11 Participants64 Participants
Race/Ethnicity, Customized
Missing
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Multiple
2 Participants3 Participants0 Participants0 Participants64 Participants67 Participants67 Participants59 Participants262 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Unknown
0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
White
24 Participants28 Participants29 Participants25 Participants75 Participants67 Participants79 Participants80 Participants407 Participants
Sex/Gender, Customized
Female
17 Participants12 Participants20 Participants17 Participants93 Participants94 Participants78 Participants90 Participants421 Participants
Sex/Gender, Customized
Male
18 Participants22 Participants15 Participants18 Participants86 Participants84 Participants101 Participants86 Participants430 Participants
Sex/Gender, Customized
Missing
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
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
deaths
Total, all-cause mortality
0 / 350 / 340 / 350 / 340 / 1801 / 1780 / 1760 / 176
other
Total, other adverse events
28 / 3528 / 3429 / 3525 / 34160 / 180164 / 178159 / 176158 / 176
serious
Total, serious adverse events
0 / 351 / 340 / 350 / 343 / 1809 / 1788 / 1769 / 176

Outcome results

Primary

For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3

Percentage of infants with serotype specific IgG concentration \>=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Time frame: Day 150

Population: Per protocol analysis set 2 (PPAS2) was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (NUMBER)
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 10A93.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 18C97.0 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19F100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 33F91.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9N99.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 23F97.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 197.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 899.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 22F100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 394.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 15B98.5 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 497.0 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19A94.0 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 598.5 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 12F97.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6A99.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 7F100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6B85.7 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 11A98.5 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9V96.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 1499.2 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9V89.3 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6B81.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 18C97.5 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 15B95.9 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9N98.4 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 12F93.4 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19F99.2 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 7F100 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 596.7 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19A93.4 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 23F96.7 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 22F97.5 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 8100 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 10A92.6 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 196.7 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 33F89.3 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6A96.7 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 495.9 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 395.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 1499.2 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 11A100 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 11A97.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6B84.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9V94.4 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19A96.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 195.2 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 397.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 497.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 593.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6A99.2 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 7F99.2 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 1497.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 18C97.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19F96.8 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 23F96.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 899.2 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9N98.4 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 10A96.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 12F94.4 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 15B97.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 22F97.6 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 33F92.8 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 1496.9 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9V99.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 33F3.8 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 10A3.8 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 7F100 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6A99.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 11A7.6 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 597.0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 497.7 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 22F3.0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 12F0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 381.8 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 6B97.0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 15B6.9 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 23F93.9 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 197.0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 89.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19F99.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 18C96.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 19A97.0 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3Serotype 9N65.9 percentage of participants
Primary

For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3

The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Time frame: Day 150

Population: PPAS2 was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 40.900 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 23F2.69 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12F1.93 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 15B7.88 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 53.62 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 22F12.3 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9N2.53 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 147.49 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6A3.41 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 33F2.67 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11A2.52 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19F3.32 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6B1.95 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 7F3.88 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 83.27 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19A1.86 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9V1.35 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 30.800 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 10A2.86 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 18C1.67 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11.91 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 53.26 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 22F10.4 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19F3.31 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12F1.56 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 23F1.96 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12.21 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 82.87 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 33F2.61 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11A2.51 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9N2.39 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6B1.64 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 10A2.84 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9V1.16 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 40.880 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 31.14 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 15B7.161 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6A2.77 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 146.83 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 7F3.68 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19A1.74 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 18C1.56 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 10A3.26 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11A2.32 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12F1.54 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 15B6.84 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 31.17 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 22F9.27 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9V1.49 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 33F2.57 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 41.06 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6B1.97 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 53.00 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6A3.26 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 146.84 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 18C1.46 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19A1.86 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 7F3.45 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19F2.95 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 23F2.05 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 83.08 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11.97 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9N2.42 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 33F0.093 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6B2.87 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9V2.41 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 18C1.92 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12.81 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 30.676 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 41.63 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 51.88 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 6A4.53 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 7F3.93 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 147.41 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19A2.17 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 19F3.70 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 23F1.71 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 80.105 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 9N0.510 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 10A0.098 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 11A0.108 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 12F0.076 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 15B0.097 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3Serotype 22F0.092 mcg/mL
Primary

For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4

The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Time frame: Day 330

Population: Per protocol analysis set 3 (PPAS3) was a subset of Full analysis set 3 (FAS3). FAS3: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine at time of booster and had a valid post-booster vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 84.64 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19F6.64 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 10A5.67 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 23F3.78 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 13.16 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 22F24.5 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9N4.16 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 57.56 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6A9.44 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 41.37 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 15B19.6 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6B8.77 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 7F4.42 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 33F4.74 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 12F2.68 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9V2.20 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 30.755 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 146.94 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 11A3.66 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 18C1.79 mcg/mL
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19A6.92 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9V2.06 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 10A5.70 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 18C1.66 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19F7.48 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 22F21.3 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6B8.36 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 41.25 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 23F2.90 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 12F2.25 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9N4.23 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 33F4.83 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 84.36 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 11A3.92 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 7F4.19 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19A7.36 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 56.46 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 13.59 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 15B17.3 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 146.77 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6A8.08 mcg/mL
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 31.07 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6A7.80 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 18C1.55 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 13.44 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 31.03 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 41.75 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 56.63 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6B7.96 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 7F3.76 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9V2.57 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 147.70 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19A7.72 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19F6.68 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 23F2.99 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 84.26 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9N3.80 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 10A4.78 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 11A3.22 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 12F2.04 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 15B15.7 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 22F20.6 mcg/mL
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 33F4.62 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 10A0.160 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 148.73 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9V4.32 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 22F0.173 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 11A0.154 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 7F5.41 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6B8.54 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 13.89 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 12F0.080 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 6A10.8 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 53.07 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 18C2.81 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 15B0.114 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 42.41 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 80.238 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 23F3.54 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 30.961 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 9N0.953 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19F7.03 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 19A7.38 mcg/mL
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4Serotype 33F0.158 mcg/mL
Primary

For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose

The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.

Time frame: Day 30

Population: Per protocol analysis set 1 (PPAS1) was a subset of Full analysis set (FAS)1. FAS1: All randomized participants to Groups 1 to 4 who received at least 1 dose of study vaccine and had a valid post vaccination blood sample result \[serotype specific IgG concentration or serotype specific opsonophagocytic activity (OPA) titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines\]. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19A3.67 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6B5.21 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 86.86 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 23F2.42 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 15B0.680 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 7F2.99 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 52.44 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 33F1.26 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9N3.46 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9V3.25 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19F3.88 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12.46 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12F0.767 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 147.37 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 22F4.43 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 41.53 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6A7.53 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 18C1.80 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 10A1.84 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 30.766 microgram/millilitre (mcg/mL)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 11A4.41 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 15B0.560 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19A5.41 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 10A1.05 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19F4.12 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 23F2.65 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 22F4.26 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9N2.02 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 84.91 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 52.38 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 33F1.13 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6A5.87 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6B4.16 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12.12 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 7F3.23 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12F0.778 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9V2.99 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 30.973 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 146.54 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 11A3.20 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 18C2.23 microgram/millilitre (mcg/mL)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 41.51 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9V5.27 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19F5.79 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 10A1.48 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 13.29 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 31.16 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 42.27 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 52.80 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6A8.29 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6B7.11 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 7F2.91 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 145.75 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 18C2.19 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19A5.45 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 23F3.64 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 87.11 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9N2.78 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 11A4.61 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12F0.907 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 15B0.644 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 22F5.20 microgram/millilitre (mcg/mL)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 33F1.75 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 10A0.244 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 18C2.53 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 149.83 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 22F0.178 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 11A0.188 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9V3.13 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 7F3.80 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 30.835 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 12F0.094 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6B5.77 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 6A8.54 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 13.80 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 15B0.172 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 52.69 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 41.73 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 80.235 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 23F3.02 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 33F0.256 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 9N0.668 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19F6.50 microgram/millilitre (mcg/mL)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-DoseSerotype 19A6.20 microgram/millilitre (mcg/mL)
Primary

Number of Participants With Immediate Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.

Time frame: Up to 30 minutes after each vaccination

Population: Analysis was performed on the Safety analysis set (SafAS) that included all participants who received at least 1 dose of the study vaccines and had any safety data available. One participant who was randomized to the reporting group Stage II: Group 7 SP0202-VII was administered SP0202-IIb formulation. Therefore, the participant was included in Stage II: Group 5 SP0202-IIb for analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage I: Group 1 SP0202-IIbNumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage I: Group 2 SP0202-VINumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 6 SP0202-VINumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Immediate Adverse Events (AEs)0 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Immediate Adverse Events (AEs)0 Participants
Primary

Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)

An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame: From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days

Population: Analysis was performed on SafAS. One participant who was randomized to the reporting group Stage II: Group 7 SP0202-VII was administered SP0202-IIb formulation. Therefore, the participant was included in Stage II: Group 5 SP0202-IIb for analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stage I: Group 1 SP0202-IIbNumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs1 Participants
Stage I: Group 1 SP0202-IIbNumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs0 Participants
Stage I: Group 2 SP0202-VINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs0 Participants
Stage I: Group 2 SP0202-VINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs1 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs0 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs0 Participants
Stage II: Group 8 Prevnar 13Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs0 Participants
Stage II: Group 8 Prevnar 13Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs0 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs3 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs1 Participants
Stage II: Group 6 SP0202-VINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs9 Participants
Stage II: Group 6 SP0202-VINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs1 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs1 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs8 Participants
Stage II: Group 8 Prevnar 13Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any SAEs9 Participants
Stage II: Group 8 Prevnar 13Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)Any AESIs0 Participants
Primary

Number of Participants With Solicited Injection Site Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.

Time frame: Up to 7 days after each vaccination

Population: Analysis was performed on SafAS. One participant who was randomized to the reporting group Stage II: Group 7 SP0202-VII was administered SP0202-IIb formulation. Therefore, the participant was included in Stage II: Group 5 SP0202-IIb for analysis. Only participants with data collected for each specified category are reported.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage I: Group 1 SP0202-IIbNumber of Participants With Solicited Injection Site Reactions21 Participants
Stage I: Group 2 SP0202-VINumber of Participants With Solicited Injection Site Reactions18 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Solicited Injection Site Reactions21 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Solicited Injection Site Reactions13 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With Solicited Injection Site Reactions119 Participants
Stage II: Group 6 SP0202-VINumber of Participants With Solicited Injection Site Reactions128 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Solicited Injection Site Reactions126 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Solicited Injection Site Reactions124 Participants
Primary

Number of Participants With Solicited Systemic Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame: Up to 7 days after each vaccination

Population: Analysis was performed on SafAS. One participant who was randomized to the reporting group Stage II: Group 7 SP0202-VII was administered SP0202-IIb formulation. Therefore, the participant was included in Stage II: Group 5 SP0202-IIb for analysis. Only participants with data collected for this outcome measure are reported.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage I: Group 1 SP0202-IIbNumber of Participants With Solicited Systemic Reactions25 Participants
Stage I: Group 2 SP0202-VINumber of Participants With Solicited Systemic Reactions23 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Solicited Systemic Reactions27 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Solicited Systemic Reactions24 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With Solicited Systemic Reactions139 Participants
Stage II: Group 6 SP0202-VINumber of Participants With Solicited Systemic Reactions143 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Solicited Systemic Reactions137 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Solicited Systemic Reactions138 Participants
Primary

Number of Participants With Unsolicited AEs

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame: Up to 30 days after each vaccination

Population: Analysis was performed on SafAS. One participant who was randomized to the reporting group Stage II: Group 7 SP0202-VII was administered SP0202-IIb formulation. Therefore, the participant was included in Stage II: Group 5 SP0202-IIb for analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage I: Group 1 SP0202-IIbNumber of Participants With Unsolicited AEs7 Participants
Stage I: Group 2 SP0202-VINumber of Participants With Unsolicited AEs3 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Unsolicited AEs4 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Unsolicited AEs6 Participants
Stage II: Group 5 SP0202-IIbNumber of Participants With Unsolicited AEs122 Participants
Stage II: Group 6 SP0202-VINumber of Participants With Unsolicited AEs116 Participants
Stage II: Group 7 SP0202-VIINumber of Participants With Unsolicited AEs118 Participants
Stage II: Group 8 Prevnar 13Number of Participants With Unsolicited AEs117 Participants
Secondary

For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3

Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.

Time frame: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

ArmMeasureValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3407 Units (U)/mL
Stage I: Group 2 SP0202-VIFor Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3390 Units (U)/mL
Stage II: Group 7 SP0202-VIIFor Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3494 Units (U)/mL
Stage II: Group 8 Prevnar 13For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3393 Units (U)/mL
Secondary

For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3

Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.

Time frame: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertussis toxoid/toxin67.9 ELISA units (EU)/mL
Stage I: Group 1 SP0202-IIbFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Filamentous hemagglutinin109 ELISA units (EU)/mL
Stage I: Group 1 SP0202-IIbFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertactin38.3 ELISA units (EU)/mL
Stage I: Group 1 SP0202-IIbFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Fimbriae types 2 and 3347 ELISA units (EU)/mL
Stage I: Group 2 SP0202-VIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Filamentous hemagglutinin107 ELISA units (EU)/mL
Stage I: Group 2 SP0202-VIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertactin36.1 ELISA units (EU)/mL
Stage I: Group 2 SP0202-VIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Fimbriae types 2 and 3341 ELISA units (EU)/mL
Stage I: Group 2 SP0202-VIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertussis toxoid/toxin77.2 ELISA units (EU)/mL
Stage II: Group 7 SP0202-VIIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertactin39.8 ELISA units (EU)/mL
Stage II: Group 7 SP0202-VIIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Filamentous hemagglutinin108 ELISA units (EU)/mL
Stage II: Group 7 SP0202-VIIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Fimbriae types 2 and 3315 ELISA units (EU)/mL
Stage II: Group 7 SP0202-VIIFor Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertussis toxoid/toxin66.3 ELISA units (EU)/mL
Stage II: Group 8 Prevnar 13For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Fimbriae types 2 and 3343 ELISA units (EU)/mL
Stage II: Group 8 Prevnar 13For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Filamentous hemagglutinin104 ELISA units (EU)/mL
Stage II: Group 8 Prevnar 13For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertussis toxoid/toxin68.3 ELISA units (EU)/mL
Stage II: Group 8 Prevnar 13For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3Pertactin45.2 ELISA units (EU)/mL
Secondary

For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3

Percentage of participants with toxoid concentration \>=0.10 mcg/mL for diphtheria and tetanus and \>=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.

Time frame: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (NUMBER)
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Diphtheria toxoid94.6 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-PRP99.2 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Tetanus toxoid100 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Diphtheria toxoid97.5 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-PRP99.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Tetanus toxoid100 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Tetanus toxoid100 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Diphtheria toxoid95.9 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-PRP98.2 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Diphtheria toxoid96.9 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-PRP100 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3Anti-Tetanus toxoid100 percentage of participants
Secondary

For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3

Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is \>=10 milli international units (mIU).

Time frame: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.

ArmMeasureValue (NUMBER)
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 398.3 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 399.1 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 398.1 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 399.2 percentage of participants
Secondary

For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4

Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations \>=255 mIU/mL, anti-mumps antibody concentrations: \>=10 antibody units/mL, anti-rubella antibody concentrations \>=10 IU/mL and anti-varicella concentrations \>=5 units/mL is reported in this outcome measure.

Time frame: Day 330

Population: Results are based on PPAS3 which is a subset of the FAS3 for infants. Only participants with data collected for this outcome measure are reported.

ArmMeasureGroupValue (NUMBER)
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Varicella100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Rubella98.3 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Measles97.5 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Mumps99.2 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Mumps97.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Measles97.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Rubella98.1 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Varicella99.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Rubella99.0 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Varicella95.9 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Mumps96.9 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Measles96.9 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Varicella98.4 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Measles98.4 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Mumps98.4 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4Anti-Rubella98.4 percentage of participants
Secondary

For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3

Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer \>=8.

Time frame: Day 150

Population: Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (NUMBER)
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 3100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 2100 percentage of participants
Stage I: Group 1 SP0202-IIbFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 199.2 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 2100 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 1100 percentage of participants
Stage I: Group 2 SP0202-VIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 3100 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 197.4 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 299.1 percentage of participants
Stage II: Group 7 SP0202-VIIFor Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 399.1 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 2100 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 3100 percentage of participants
Stage II: Group 8 Prevnar 13For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3Anti-poliovirus 1100 percentage of participants
Secondary

For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3

The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

Time frame: Day 150

Population: Results are based on PPPAS2-OPA subset which is a subset of the FAS for infants. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9N4261 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 22F5227 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 10A2306 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19F533 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 4703 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 23F2654 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 81486 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 173.6 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 5602 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 15B6686 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6A2456 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6B1436 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 33F10070 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 7F5964 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 12F2182 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9V898 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 3170 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 141959 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 11A52.6 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 18C866 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19A640 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 12F2179 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 11A64.9 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6B1041 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 18C819 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19F591 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 141767 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9N4994 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 7F5449 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 23F1967 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 4616 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19A512 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 22F4657 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 81440 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 3218 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 15B5859 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 33F11179 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 5492 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 181.7 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9V700 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6A2223 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 10A2722 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6A2664 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 166.4 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 3260 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 41154 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 5495 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6B1885 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 7F5889 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9V1136 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 142293 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 18C804 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19A778 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19F629 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 23F2279 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 81612 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9N5257 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 10A3251 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 11A76.6 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 12F2334 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 15B5220 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 22F4617 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 33F11900 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 1114 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 10A9.42 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 141920 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9V1319 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 33F311 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 11A5.91 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 7F5252 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6A2799 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 22F16.1 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 12F5.31 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 5569 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 41789 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 6B2472 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 15B28.1 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 8133 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 23F4299 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19F613 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 3178 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 9N811 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 19A1130 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3Serotype 18C1000 1/dil
Secondary

For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4

The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

Time frame: Day 330

Population: Results are based on PPAS3-OPA subset which is a subset of the FAS3 for infants. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 1407 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 3274 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 43754 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 52348 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6A5153 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6B3899 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 7F10234 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9V3044 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 143415 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 18C1891 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19A3808 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19F2071 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 23F5444 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 84559 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9N9479 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 10A4278 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 11A433 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 12F4520 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 15B14756 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 22F20372 1/dil
Stage I: Group 1 SP0202-IIbFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 33F26134 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 12F4757 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 1355 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9V2641 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19F1821 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 7F8643 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 10A4797 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9N8565 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 23F4444 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 42536 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 22F16063 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 11A390 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 84229 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 143098 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6A4786 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6B3305 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 33F21202 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 18C1422 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 51787 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 3308 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 15B13136 1/dil
Stage I: Group 2 SP0202-VIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19A3086 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 3376 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6B3638 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 7F9232 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 12F5030 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9V2956 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 144190 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 18C1368 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19A3580 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 15B12799 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19F1654 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 23F4047 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 33F32376 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 84916 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9N10257 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 22F21319 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 10A4768 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 1320 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 45556 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 11A550 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 52131 1/dil
Stage II: Group 7 SP0202-VIIFor Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6A4433 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 10A46.6 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19A7535 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 11A8.11 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 1318 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 22F65.7 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 18C2821 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 143378 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 3348 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 12F7.92 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9V4364 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6B7092 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 46028 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 33F3224 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 8773 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 23F18569 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 15B55.2 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 7F13971 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 9N3043 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 6A6862 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 19F2249 1/dil
Stage II: Group 8 Prevnar 13For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4Serotype 51396 1/dil
Secondary

For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose

The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.

Time frame: Day 30

Population: Results are based on PPAS1 which is a subset of the FAS1 for toddlers. Only participants with data collected for each specified category are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 43467 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 1138 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 3272 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 51287 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6A4623 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6B3027 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 7F8449 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9V3612 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 143598 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 18C1490 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19A3082 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19F1194 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 23F5451 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 84244 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9N11562 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 10A3582 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 11A611 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 12F6767 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 15B1087 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 22F4106 1/dilution (1/dil)
Stage I: Group 1 SP0202-IIbFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 33F39691 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 12F7391 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 10A3615 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9V3254 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19F1806 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 7F7640 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9N8391 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 22F3352 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 23F7457 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 42862 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 87003 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6B3542 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 3314 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 143881 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6A6083 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 11A686 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 33F30399 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 18C1760 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 51333 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 194.2 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 15B1346 1/dilution (1/dil)
Stage I: Group 2 SP0202-VIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19A3174 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 33F35326 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6B5171 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 7F6284 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 12F7955 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9V4720 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 143191 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 18C1722 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19A3004 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 15B1476 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19F1569 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 23F5179 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 87989 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9N12115 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 22F4443 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 10A4001 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 1177 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 3393 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 45420 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 11A661 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 51397 1/dilution (1/dil)
Stage II: Group 7 SP0202-VIIFor Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6A7232 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 10A10.0 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 22F69.0 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 18C2424 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 51307 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 1247 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 142828 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 12F5.27 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 11A4.14 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 3216 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9V4057 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6B4679 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 23F9264 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 42975 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 8222 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 15B37.7 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19F2554 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 33F2689 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 9N2061 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 7F10443 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 19A5354 1/dilution (1/dil)
Stage II: Group 8 Prevnar 13For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-DoseSerotype 6A7553 1/dilution (1/dil)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026