Pneumococcal Immunization
Conditions
Brief summary
Primary Objectives: * Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination * Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
Detailed description
The duration of each participant's participation was approximately 6 months.
Interventions
BIOLOGICALPneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICALPneumococcal Conjugate Vaccine - formulation 2-SP0202-VI
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICALPneumococcal Conjugate Vaccine - formulation 3-SP0202-VII
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICALPneumococcal 13 - valent conjugate vaccine-Prevnar 13
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
BIOLOGICALPneumococcal Vaccine Polyvalent-Pneumovax 23
Pharmaceutical form:Solution for injection Route of administration: intramuscular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
: \- Aged 50 to 84 years on the day of inclusion .
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure. * Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV). * Received 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 S. pneumoniae infection or disease, confirmed either serologically, or microbiologically. * History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine. * Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine \< 10 years ago. * Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances . * Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion. * At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity). * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 \[COVID-19\]). * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 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 subsided. * Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Post-vaccination at Day 31 | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 | The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. |
| Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Post-vaccination at Day 31 | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. |
| Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31 | The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1. |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Within 30 minutes post-vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. |
| Number of Participants With Solicited Injection Site Reactions | Up to 7 Days post-vaccination (Day 8) | A solicited reaction was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling. |
| Number of Participants With Solicited Systemic Reactions | Up to 7 Days post-vaccination (Day 8) | A solicited reaction was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering. |
| Number of Participants With Unsolicited AEs | Within 30 days post-vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days | 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 was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 17 investigational sites in United States between 08 Oct 2020 to 20 Jan 2022.
Pre-assignment details
A total of 750 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: SP0202-IIb Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1. | 151 |
| Group 2: SP0202-VI Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1. | 151 |
| Group 3: SP0202-VII Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1. | 149 |
| Group 4: Prevnar 13 Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1. | 149 |
| Group 5: Pneumovax 23 Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1. | 150 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 3 | 1 | 1 |
| Overall Study | Protocol deviation | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Group 2: SP0202-VI | Group 3: SP0202-VII | Group 4: Prevnar 13 | Group 1: SP0202-IIb | Group 5: Pneumovax 23 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 6.6 | 62.9 Years STANDARD_DEVIATION 6.5 | 63.4 Years STANDARD_DEVIATION 6.8 | 63.3 Years STANDARD_DEVIATION 6.9 | 63.1 Years STANDARD_DEVIATION 7.2 | 63.2 Years STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 9 Participants | 10 Participants | 10 Participants | 11 Participants | 49 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 24 Participants | 10 Participants | 19 Participants | 13 Participants | 83 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 113 Participants | 127 Participants | 120 Participants | 121 Participants | 604 Participants |
| Sex: Female, Male Female | 84 Participants | 78 Participants | 86 Participants | 76 Participants | 93 Participants | 417 Participants |
| Sex: Female, Male Male | 67 Participants | 71 Participants | 63 Participants | 75 Participants | 57 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 1 / 151 | 1 / 148 | 0 / 149 | 0 / 150 |
| other Total, other adverse events | 113 / 151 | 122 / 151 | 112 / 148 | 102 / 149 | 93 / 150 |
| serious Total, serious adverse events | 3 / 151 | 7 / 151 | 3 / 148 | 2 / 149 | 2 / 150 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Time frame: Post-vaccination at Day 31
Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 5.50 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 3.77 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 7.16 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 1.97 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 7.98 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 2.91 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 6.56 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 3.57 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 2.35 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 4.85 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 5.73 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 5.26 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 2.18 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 7.41 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 7.35 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 2.98 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 12.4 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 6.04 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 13.4 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 0.746 mcg/mL |
| Group 1: SP0202-IIb | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 7.14 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 9.48 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 5.52 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 4.91 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 6.25 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 4.50 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 3.28 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 0.977 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 5.00 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 4.02 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 1.63 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 2.16 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 3.62 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 5.56 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 9.15 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 16.3 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 3.17 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 10.5 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 5.39 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 2.09 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 11.7 mcg/mL |
| Group 2: SP0202-VI | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 8.35 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 6.23 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 4.31 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 1.22 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 3.78 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 4.17 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 7.75 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 9.52 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 6.59 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 1.90 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 5.41 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 7.37 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 4.27 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 4.37 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 2.16 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 14.8 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 4.83 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 6.54 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 5.35 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 7.03 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 10.9 mcg/mL |
| Group 3: SP0202-VII | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 2.27 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 10.3 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 4.34 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 7.89 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 0.884 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 5.93 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 0.899 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 3.28 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 6.45 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 10.1 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 5.30 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 10.5 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 18.3 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 9.38 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 6.99 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 0.935 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 1.60 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 1.06 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 0.190 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 1.84 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 0.350 mcg/mL |
| Group 4: Prevnar 13 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 1.50 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 4.47 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 7.59 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 5.44 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 14.6 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 1.53 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 1.03 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 3.48 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 4.23 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 2.47 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 3.98 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 13.6 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 1.72 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 0.858 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 7.43 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 16.4 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 2.41 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 6.41 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 3.88 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 9.11 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 9.84 mcg/mL |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 3.02 mcg/mL |
Primary
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 9.21 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 7.97 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 4.74 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 13.2 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 4.97 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 5.39 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 4.54 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 7.77 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 6.52 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 2.99 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 8.70 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 5.43 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 5.57 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 13.8 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 8.45 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 12.2 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 4.91 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 10.6 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 6.52 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 5.65 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 6.52 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 4.02 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 8.44 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 6.13 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 9.67 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 8.76 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 11.6 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 11.0 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 9.63 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 12.2 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 11.2 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 10.0 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 6.47 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 10.0 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 8.39 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 9.47 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 5.59 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 5.91 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 6.44 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 7.18 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 6.29 Ratio |
| Group 2: SP0202-VI | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 5.81 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 9.65 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 10.7 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 4.93 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 7.33 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 4.60 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 12.6 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 7.93 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 7.87 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 6.21 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 7.86 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 6.41 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 11.9 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 8.20 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 4.62 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 9.99 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 7.55 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 5.36 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 8.05 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 8.74 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 8.99 Ratio |
| Group 3: SP0202-VII | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 4.43 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 1.26 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 1.09 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 10.8 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 2.81 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 11.6 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 1.08 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 9.12 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 3.86 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 16.2 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 19.3 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 1.35 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 11.2 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 1.03 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 1.15 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 12.3 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 1.18 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 13.0 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 5.96 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 16.3 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 12.1 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 10.6 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 1 | 11.5 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 8 | 13.9 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 7F | 6.80 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9V | 6.30 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6B | 5.51 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 14 | 7.35 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 9N | 11.3 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 6A | 3.30 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 22F | 7.30 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 10A | 9.84 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 5 | 8.93 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 11A | 5.54 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 3 | 3.52 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 12F | 5.07 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 15B | 9.87 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 33F | 9.43 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19F | 6.18 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 19A | 5.74 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 23F | 5.70 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 18C | 6.91 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL | Serotype 4 | 5.47 Ratio |
Primary
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
Time frame: Post-vaccination at Day 31
Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 2067 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 3487 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 3492 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 1363 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 3699 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 1494 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 136 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 5253 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 241 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 475 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 1999 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 826 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 897 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 128 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 3501 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 4930 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 3756 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 7313 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 2931 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 3656 Titer |
| Group 1: SP0202-IIb | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 905 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 1377 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 802 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 1576 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 3395 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 1773 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 1306 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 127 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 4639 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 230 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 4823 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 3917 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 3074 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 438 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 3582 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 2841 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 217 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 2856 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 828 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 3858 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 4407 Titer |
| Group 2: SP0202-VI | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 8324 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 158 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 263 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 2134 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 201 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 2672 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 3479 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 2403 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 986 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 3244 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 1025 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 3462 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 1678 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 1701 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 1486 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 4207 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 2811 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 318 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 3117 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 4858 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 7641 Titer |
| Group 3: SP0202-VII | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 3613 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 3675 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 536 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 4253 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 2941 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 160 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 62.5 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 1641 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 157 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 254 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 1201 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 18.3 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 5122 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 1525 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 1082 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 4417 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 3350 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 74.8 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 1792 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 104 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 1929 Titer |
| Group 4: Prevnar 13 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 8.31 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 3999 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 2039 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 1159 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 2261 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 6096 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 2250 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 3011 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 443 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 390 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 377 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 1906 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 1345 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 1873 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 177 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 3346 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 15082 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 983 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 1177 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 2153 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 488 Titer |
| Group 5: Pneumovax 23 | Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 289 Titer |
Primary
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
Population: PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 20.7 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 45.2 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 7.36 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 50.8 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 13.1 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 17.0 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 4.21 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 15.2 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 8.90 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 39.0 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 60.8 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 7.06 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 30.1 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 29.1 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 240 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 14.8 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 9.50 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 24.2 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 7.44 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 8.40 Ratio |
| Group 1: SP0202-IIb | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 18.6 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 69.4 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 20.6 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 49.0 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 43.0 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 24.1 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 34.3 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 13.1 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 9.90 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 30.7 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 10.5 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 25.7 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 28.8 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 12.8 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 6.27 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 12.9 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 252 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 19.5 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 24.7 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 41.4 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 15.9 Ratio |
| Group 2: SP0202-VI | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 14.3 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 8.44 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 9.79 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 13.7 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 33.0 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 12.2 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 59.2 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 29.2 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 12.7 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 18.9 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 11.5 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 20.8 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 43.9 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 24.0 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 20.8 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 9.28 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 167 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 20.7 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 38.5 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 4.36 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 24.0 Ratio |
| Group 3: SP0202-VII | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 11.5 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 21.3 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 1.21 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 17.2 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 0.964 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 37.4 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 0.931 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 0.878 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 8.52 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 49.3 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 58.9 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 1.37 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 15.5 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 1.05 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 26.6 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 0.975 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 2.84 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 43.1 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 79.1 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 45.5 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 79.1 Ratio |
| Group 4: Prevnar 13 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 10.1 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 14 | 9.05 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 3 | 9.52 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 8 | 37.6 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9N | 14.6 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 9V | 10.6 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 10A | 22.9 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 7F | 31.0 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 11A | 13.7 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6B | 16.6 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 1 | 19.1 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 12F | 102 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 6A | 9.18 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 15B | 22.8 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 5 | 24.2 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 22F | 21.0 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 4 | 25.7 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19A | 7.88 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 19F | 17.2 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 18C | 22.1 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 33F | 10.4 Ratio |
| Group 5: Pneumovax 23 | Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA | Serotype 23F | 11.6 Ratio |
Primary
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Time frame: Within 30 minutes post-vaccination
Population: Safety analysis set (SafAS) included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: SP0202-IIb | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
| Group 2: SP0202-VI | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
| Group 3: SP0202-VII | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 1 Participants |
| Group 4: Prevnar 13 | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (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 was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.
Time frame: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days
Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: SP0202-IIb | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 3 Participants |
| Group 1: SP0202-IIb | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 2: SP0202-VI | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 7 Participants |
| Group 2: SP0202-VI | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 3: SP0202-VII | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 3 Participants |
| Group 3: SP0202-VII | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 4: Prevnar 13 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 4: Prevnar 13 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 2 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 2 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.
Time frame: Up to 7 Days post-vaccination (Day 8)
Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: SP0202-IIb | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 17 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 106 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 14 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 25 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 113 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 19 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 19 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 107 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 14 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 85 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 4 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 3 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 9 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 74 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 6 Participants |
Primary
Number of Participants With Solicited Systemic Reactions
A solicited reaction was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.
Time frame: Up to 7 Days post-vaccination (Day 8)
Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Headache | 43 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Shivering | 20 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Malaise | 36 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Arthralgia | 23 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Myalgia | 57 Participants |
| Group 1: SP0202-IIb | Number of Participants With Solicited Systemic Reactions | Fever | 3 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Malaise | 43 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Shivering | 27 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Headache | 47 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Fever | 2 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Myalgia | 71 Participants |
| Group 2: SP0202-VI | Number of Participants With Solicited Systemic Reactions | Arthralgia | 30 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Headache | 38 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Malaise | 30 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Fever | 5 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Myalgia | 56 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Shivering | 18 Participants |
| Group 3: SP0202-VII | Number of Participants With Solicited Systemic Reactions | Arthralgia | 18 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Headache | 35 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Myalgia | 49 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Malaise | 28 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Fever | 3 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Shivering | 7 Participants |
| Group 4: Prevnar 13 | Number of Participants With Solicited Systemic Reactions | Arthralgia | 17 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Shivering | 13 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Fever | 4 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Headache | 41 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Malaise | 32 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Myalgia | 65 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Solicited Systemic Reactions | Arthralgia | 29 Participants |
Primary
Number of Participants With Unsolicited AEs
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 30 days post-vaccination
Population: SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: SP0202-IIb | Number of Participants With Unsolicited AEs | 21 Participants |
| Group 2: SP0202-VI | Number of Participants With Unsolicited AEs | 34 Participants |
| Group 3: SP0202-VII | Number of Participants With Unsolicited AEs | 19 Participants |
| Group 4: Prevnar 13 | Number of Participants With Unsolicited AEs | 18 Participants |
| Group 5: Pneumovax 23 | Number of Participants With Unsolicited AEs | 20 Participants |