Pneumococcal Disease
Conditions
Brief summary
Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young adults and PCV-primed toddlers through 4 weeks post vaccination. Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during the screening visit for safety and potential immunological assessments, and 28 days after completion of the vaccination schedule for immunological assessments. For adults, the vaccine was given intramuscularly into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7 post-vaccination visit.
Detailed description
This was a prospective, single-center, randomized, active-controlled, double-blind, age de escalation study in healthy Gambian PCV-naïve adults (18-40 years old), PCV primed toddlers (12-15 months old) and PCV-naïve infants (6-8 weeks old). In the adult cohort, at least 34 eligible PCV-naïve adults (18-40 years old) were planned to be randomized into the study to receive a single dose of either SIILPCV10 or Pneumovax 23 in a 1:1 ratio on Day 0 (V1), with stratification by sex (although no fixed proportion of males and females was required in the cohort as a whole). In the toddler cohort, at least 112 eligible PCV-primed toddlers (12-15 months old) were planned to be randomized into the study to receive a single dose of either SIILPCV10 or Prevenar 13 in a 1:1 ratio on Day 0 (V1). Each adult and toddler subject underwent a total of 4 clinic visits, including at least 1 screening visit (V0) no more than 14 days prior to Day 0, a vaccination visit on Day 0 (V1), and follow-up clinic visits at 7 (+3) and 28 (+14) days after vaccination (V2 and V3, respectively). A total of 3 blood samples were obtained for laboratory safety and immunogenicity assessments. In the infant cohort, at least 200 eligible PCV-naïve infants (6 to 8 weeks old) were randomized into the study to receive 3 doses of either SIILPCV10 or Prevenar 13 in a 1:1 ratio along with standard Expanded Program on Immunisation (EPI) vaccinations (pentavalent diphtheria, tetanus, whole-cell pertussis, hepatitis B, and Haemophilus influenzae type b combined vaccine \[DTwP-HepB-Hib\], oral poliovirus vaccine \[OPV\], rotavirus vaccine \[RV\], and inactivated poliovirus vaccine \[IPV\]). Each infant subject underwent a total of 9 scheduled visits for the primary series: at least 1 screening visit (V0); 3 primary vaccination visits at 28 (+14)-day intervals (V1, 3, 5); follow-up clinic visits at 7 (+3) days after each primary vaccination (V2, 4, 6); and 2 follow-up visits 28 and 84 days after the last primary vaccination (V7 and V8, respectively). Windows for follow-up and subsequent vaccination visits were calculated based on the actual calendar date of the prior vaccination, rather than relative to the day of randomization. Vaccinations included the blinded PCV study vaccine (SIILPCV10 or Prevenar 13) and the unblinded EPI vaccines (DTwP-HepB-Hib, OPV, RV, and IPV). A total of 2 blood samples were obtained for the primary series (V0 and V7), with the first sample used for safety laboratory eligibility assessment, and if randomized, for baseline immunogenicity testing. Immunogenicity testing was also done on the second sample. During the supplemental booster phase, infant subjects underwent 2 additional visits: a fourth (booster) vaccination visit (V9) at ≥ 9 months of age, and a follow-up visit 28 days after the booster dose (V10). The EPI vaccines scheduled for 9 months of age in The Gambia were not given as part of the study. However, study personnel contacted parents of infant subjects to remind them of the need to attend this EPI vaccination visit at the due date to allow for effective scheduling of the subsequent booster. The vaccine (SIILPCV10 or Prevenar 13) was given at least 4 weeks after the routine EPI vaccines given at 9 months of age in The Gambia (measles and rubella, yellow fever, and OPV). Infants who received SIILPCV10 at V9 were offered a booster dose of Prevenar 13 at least 56 days following the SIILPCV10 boost. Immunogenicity testing was performed on 2 additional blood samples collected during the booster phase (V9 and V10). In the adult and toddler cohorts, on the day of vaccination, a malaria rapid test was performed using a finger prick to rule out parasitemia and a urine pregnancy test was performed (in adult women who were not surgically sterile) to rule out pregnancy before final eligibility was confirmed and randomization occurred. In the infant cohort, on each day of vaccination, a malaria rapid test was performed using a finger prick to rule out parasitemia before vaccination occurred. Any infant showing signs of acute illness or abnormal vital signs on the day of vaccination were not vaccinated until recovery was documented by the study team. After all vaccinations, subjects were monitored for solicited reactogenicity. All adult and toddler subjects were monitored for AEs at each clinic visit until V3, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs at each clinic visit until V8. For infants who participated in the booster phase of the study, AEs were recorded at V10, and any conditions present at V9 were considered baseline. SAS software was used to analyze data.
Interventions
BIOLOGICALSIILPCV10
10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate \[alum\]) and preservative (thiomersal).
BIOLOGICALPneumovax 23
23-valent Pneumococcal Polysaccharide Vaccine (Pneumovax 23; MSD Pharmaceuticals) for the adult cohort.
BIOLOGICALPrevenar 13
13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts
Sponsors
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* • Healthy adults (18-40 yrs), toddlers (12-15 mo), full term infants (6-8 wks) and ≥ 3.5 kg * Able to provide informed consent (for themselves or child) * Willing to comply with study requirements and procedures. * Toddlers have completed their Gambian infant EPI schedule * Infants who have received the birth doses of BCG, HepB and OPV but who have not received any additional vaccines. * Infants and toddlers with a weight-to-height Z score of ≥ -2. * Subjects resident in the study area with no plans to travel outside the study area during the period of study participation.
Exclusion criteria
* Use of any investigational medicinal product within 90 days prior to randomization and throughout the study. * Ingestion of herbal or other traditional local medication within 14 days of randomization. * Adults and infants who have previously been vaccinated against S. pneumoniae. * History of S. pneumoniae infection confirmed by culture from a normally sterile site. * History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. * History of anaphylactic shock. * Screening laboratory test or vital signs outside the normal range. * HIV-positive or HbsAg- positive based on testing during screening. * Acute illness (moderate or severe) and/or fever (axillary temperature of ≥ 38.0°C for adults or ≥ 37.5°C for toddlers and infants). * Use of antibiotics within 5 days of randomization (excluding treatment for malaria). * A positive test for malaria at time of screening, which remains positive post treatment when retested at time of randomization (Day 0). * Administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation. * Chronic administration of immunosuppressant or other immune modifying drugs prior to the administration of the study. The use of topical and inhaled glucocorticoids will be permitted. * Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or during the study period. * History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. * Employee of, or direct descendant of any person employed by the Sponsor, the CRO, the PI, study site personnel, or site. Adults only * Recent history or signs of alcohol or substance abuse. * History of major psychiatric disorder. * Female adult subjects who are pregnant or breast-feeding. Infants/Toddlers only * Family history of suspected primary immunodeficiency in first-degree relative. * Had a sibling die suddenly and without apparent other cause or preceding illness in the first year of life. * Evidence of a clinically significant congenital abnormality as judged by the PI. * Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy. * History of meningitis, seizures or any neurological disorder. * Evidence of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other bloodborne mechanisms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | 28 days | Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated. |
| Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | 7 days | Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants). |
| Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | 7 days | Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants). |
| Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | 7 days | Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants). |
| Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | 7 days after vaccination | Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia. |
| Occurrence, Severity and Relatedness of All Adverse Events in Infants | 12 weeks post last vaccination | Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated. |
| Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | 7 days | Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | 84 days | Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for: * Diptheria toxoid: 0.1 IU/mL * Hepatitis B: 10 milli-International unit (mIU) /mL * Hib: 0.15 mcg/mL * Tetanus toxoid: 0.1 IU/mL |
| Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | 4 weeks after third dose | Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. |
| Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | 4 weeks after vaccination | Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. |
| Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | 4 weeks after vaccination | Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. |
| Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | 4 weeks after the third dose | Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. |
| Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | 4 weeks after vaccination (28 days) | Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort. |
| Functional Antibody (OPA) Geometric Mean Titers | 4 weeks after last vaccination | The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham. |
| Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | 84 days | The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | 4 weeks (28 days) | Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants. |
| Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | 24-26 weeks | Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer. |
| Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | 20-23 weeks | Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer. |
| Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | 4 weeks (28 days) | Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants. |
| Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | 4 weeks (28 days) | Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated. |
| Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | 7 days | Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 30 (± 10) minutes following booster vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following the vaccination |
Countries
The Gambia
Participant flow
Pre-assignment details
Adult cohort: 43 screened and 9 screen failures Toddler cohort: 173 screened and 61 screen failures Infant cohort: 262 screened and 62 screen failures
Participants by arm
| Arm | Count |
|---|---|
| Adults--PCV 10 Single dose of SIILPCV 10 on Day 0 | 17 |
| Adults--Pneumovax 23 Single dose of Pneumovax 23 on Day 0 | 17 |
| Toddler--PCV 10 Single dose of SIILPCV 10 on Day 0 | 56 |
| Toddler--Prevenar 13 Single dose of Prevenar 13 on Day 0 | 56 |
| Infant--PCV 10 A 3-dose series of SIILPCV 10 on Day 0, Day 28, and Day 56. | 100 |
| Infant--Prevenar 13 A 3-dose series of Prevenar 13 on Day 0, Day 28, and Day 56. | 100 |
| Infant Boost--PCV 10 \[Subset of infants in main study\] Booster dose of SIILPCV 10 at 9 months of age | 49 |
| Infant Boost--Prevenar 13 \[Subset of infants in main study\] Booster dose of Prevenar 13 at 9 months of age | 47 |
| Total | 442 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Adults--PCV 10 | Adults--Pneumovax 23 | Total | Infant Boost--PCV 10 | Infant Boost--Prevenar 13 | Infant--PCV 10 | Infant--Prevenar 13 | Toddler--PCV 10 | Toddler--Prevenar 13 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Adults in years | 25.9 years STANDARD_DEVIATION 4.1 | 25.9 years STANDARD_DEVIATION 4.4 | 25.9 years STANDARD_DEVIATION 4.1 | — | — | — | — | — | — |
| Age, Continuous Infant Booster age in Months | — | — | 11.4 months STANDARD_DEVIATION 0.8 | 11.4 months STANDARD_DEVIATION 0.8 | 11.5 months STANDARD_DEVIATION 0.9 | — | — | — | — |
| Age, Continuous Infants--Age in Days | — | — | 47.2 Days STANDARD_DEVIATION 3.9 | — | — | 47.2 Days STANDARD_DEVIATION 4 | 47.3 Days STANDARD_DEVIATION 3.8 | — | — |
| Age, Continuous Toddler--Age in months | — | — | 13.3 Months STANDARD_DEVIATION 0.9 | — | — | — | — | 13.3 Months STANDARD_DEVIATION 0.9 | 13.3 Months STANDARD_DEVIATION 0.8 |
| Ethnicity Fula | 2 Participants | 4 Participants | 52 Participants | 6 Participants | 5 Participants | 12 Participants | 10 Participants | 6 Participants | 7 Participants |
| Ethnicity Jola | 1 Participants | 2 Participants | 49 Participants | 5 Participants | 3 Participants | 12 Participants | 12 Participants | 11 Participants | 3 Participants |
| Ethnicity Mandinka | 10 Participants | 7 Participants | 220 Participants | 23 Participants | 28 Participants | 42 Participants | 55 Participants | 28 Participants | 27 Participants |
| Ethnicity Manjago | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity Other | 1 Participants | 0 Participants | 13 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity Serahule | 0 Participants | 2 Participants | 18 Participants | 1 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants |
| Ethnicity Serere | 0 Participants | 0 Participants | 29 Participants | 5 Participants | 5 Participants | 8 Participants | 5 Participants | 3 Participants | 3 Participants |
| Ethnicity Wolof | 3 Participants | 1 Participants | 58 Participants | 9 Participants | 2 Participants | 18 Participants | 10 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized African | 17 Participants | 17 Participants | 441 Participants | 49 Participants | 47 Participants | 100 Participants | 99 Participants | 56 Participants | 56 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Gambia | 17 participants | 17 participants | 442 participants | 49 participants | 47 participants | 100 participants | 100 participants | 56 participants | 56 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 211 Participants | 20 Participants | 20 Participants | 52 Participants | 49 Participants | 30 Participants | 32 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 231 Participants | 29 Participants | 27 Participants | 48 Participants | 51 Participants | 26 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 56 | 0 / 56 | 0 / 100 | 0 / 100 | 0 / 49 | 0 / 47 |
| other Total, other adverse events | 4 / 17 | 10 / 17 | 35 / 56 | 36 / 56 | 97 / 100 | 96 / 100 | 25 / 49 | 24 / 47 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 1 / 56 | 1 / 56 | 6 / 100 | 2 / 100 | 1 / 49 | 0 / 47 |
Outcome results
Primary
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers).
Time frame: 7 days
Population: All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | None reported/normal (temp) | 14 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | None reported/normal (temp) | 16 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 1 | 3 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 1 | 10 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | None reported/normal (temp) | 11 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 1 | 6 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 1 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | None reported/normal (temp) | 7 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 1 | 1 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | None reported/normal (temp) | 17 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 4 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 2 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 3 | 0 Participants |
| Adults--PCV10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 1 | 9 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 1 | 2 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | None reported/normal (temp) | 15 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 1 | 4 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | None reported/normal (temp) | 13 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | None reported/normal (temp) | 8 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 1 | 8 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | None reported/normal (temp) | 9 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | None reported/normal (temp) | 17 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | None reported/normal (temp) | 17 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 3 | 2 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 2 | 1 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 2 | 2 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 1 | 5 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | None reported/normal (temp) | 49 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 1 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | None reported/normal (temp) | 54 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | None reported/normal (temp) | 50 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 1 | 10 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 2 | 2 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 2 | 1 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 1 | 4 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | None reported/normal (temp) | 44 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 1 | 1 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 1 | 5 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 1 | 1 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | None reported/normal (temp) | 47 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | None reported/normal (temp) | 52 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | None reported/normal (temp) | 55 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 1 | 4 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 1 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 1 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | None reported/normal (temp) | 50 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 2 | 2 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 2 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 4 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 3 | 0 Participants |
| Toddler--PCV 10 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 1 | 7 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 1 | 2 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | None reported/normal (temp) | 45 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 1 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | None reported/normal (temp) | 56 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | Grade 1 | 6 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 2 | 4 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Decreased Appetite | None reported/normal (temp) | 50 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 1 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 1 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 1 | 6 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | None reported/normal (temp) | 53 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Redness | None reported/normal (temp) | 54 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Pain (adults only) | None reported/normal (temp) | 56 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Temperature above 37.5 C | Grade 3 | 1 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | None reported/normal (temp) | 56 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 1 | 11 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | None reported/normal (temp) | 55 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 2 | 1 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 1 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 1 | 1 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Swelling | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Rash | Grade 1 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 1 | 3 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Myalgia/Arthralgia (adults only) | Grade 4 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Tenderness | None reported/normal (temp) | 44 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Irritability (toddlers only) | Grade 3 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Fatigue/Malaise/Drowsiness (inf/tod) | Grade 2 | 0 Participants |
| Toddler--Prevenar 13 | Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity | Headache (adults only) | Grade 3 | 0 Participants |
Primary
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Time frame: 7 days
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | Grade 2 | 4 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | Grade 1 | 15 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | Grade 1 | 29 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | Grade 2 | 11 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | None | 60 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | Grade 1 | 33 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | None | 63 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | Grade 1 | 8 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | None | 92 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | Grade 1 | 10 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | None | 90 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | Grade 2 | 4 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | None | 81 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | Grade 1 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | None | 99 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | Grade 1 | 4 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | None | 96 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | Grade 1 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Decreased appetite | None | 98 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | Grade 1 | 34 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | Grade 1 | 12 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | Grade 2 | 7 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | None | 90 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | Grade 2 | 5 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | Grade 1 | 29 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Temperature | None | 59 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | None | 91 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Irritability | None | 69 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Tenderness at injection site | None | 83 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | Grade 1 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Erythema/redness at injection site | Grade 1 | 8 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Drowsiness | None | 98 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1 | Induration/swelling at injection site | Grade 1 | 8 Participants |
Primary
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Time frame: 7 days
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | Grade 1 | 7 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | None | 94 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | None | 92 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | None | 82 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | Grade 1 | 11 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | Grade 1 | 6 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | Grade 2 | 7 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | Grade 1 | 35 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | Grade 1 | 9 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | None | 80 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | None | 90 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | Grade 2 | 5 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | Grade 1 | 18 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | Grade 1 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | Grade 2 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | None | 60 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | None | 99 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | Grade 1 | 16 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | None | 81 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | Grade 1 | 30 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | None | 67 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | Grade 1 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Drowsiness | None | 98 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | Grade 1 | 8 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | None | 73 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | Grade 1 | 4 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Induration/swelling at injection site | None | 82 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | Grade 1 | 13 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Irritability | Grade 2 | 3 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Decreased appetite | None | 92 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | Grade 1 | 26 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Tenderness at injection site | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Erythema/redness at injection site | None | 95 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2 | Temperature | Grade 2 | 6 Participants |
Primary
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).
Time frame: 7 days
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 2 | 4 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | None | 80 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 2 | 3 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 1 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 1 | 6 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | None | 93 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | None | 79 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 1 | 11 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | None | 87 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 3 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 1 | 33 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 3 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | None | 63 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | None | 98 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 1 | 21 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 1 | 15 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 1 | 3 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | None | 97 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 2 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 1 | 13 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 1 | 16 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | None | 59 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 1 | 3 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | None | 80 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 1 | 37 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 1 | 3 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Drowsiness | None | 97 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 1 | 9 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 1 | 19 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Tenderness at injection site | None | 79 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 2 | 4 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Decreased appetite | None | 89 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Temperature | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Induration/swelling at injection site | None | 86 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Irritability | Grade 2 | 4 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3 | Erythema/redness at injection site | None | 97 Participants |
Primary
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.
Time frame: 28 days
Population: All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement and experienced an AE at a rate of 5% or more.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Mild | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Moderate | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Mild | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Mild | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Moderate | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Mild | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Mild | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Moderate | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Moderate | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | None | 15 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Moderate | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Moderate | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Mild | 3 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Moderate | 3 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | None | 11 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Mild | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | None | 16 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Mild | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Mild | 7 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Moderate | 2 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Mild | 6 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | None | 55 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | None | 52 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Mild | 4 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | None | 49 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Mild | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Severe | 2 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Mild | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Severe | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | None | 49 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Mild | 2 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | None | 55 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | None | 53 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Mild | 7 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Mild | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | None | 48 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | None | 54 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | None | 53 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Moderate | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | None | 55 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Mild | 5 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Moderate | 2 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | None | 51 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | None | 51 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | None | 55 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Mild | 5 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Mild | 7 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Urinary tract infection (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | None | 55 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Mild | 5 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Mild | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | None | 52 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Upper respiratory infection (Both) | None | 47 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tinea infection (Toddlers) | Mild | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Moderate | 2 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling--related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site swelling (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Mild | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Dizziness--related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Tonsillitis (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | None | 51 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Toothache (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Mild | 3 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Nasopharyngitis (Toddlers) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | None | 52 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Moderate | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis (Both) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Microcytic Anemia (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain (Adults) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | Moderate | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abscess (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Axillary pain--related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Abdominal pain (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Pyrexia (Toddlers) | Mild | 2 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea (Both) | None | 50 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Moderate | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Vaccination site pruritis--related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Otitis media (Adults) | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Diarrhea--related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Food poisoning (Adults) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Furuncle (Toddlers) | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers | Gastroenteritis (Toddlers) | Mild | 4 Participants |
Primary
Occurrence, Severity and Relatedness of All Adverse Events in Infants
Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated.
Time frame: 12 weeks post last vaccination
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Diarrhea | 29 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Pyrexia | 9 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site reaction (routine vaccines) | 11 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site swelling (routine vaccines) | 55 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site swelling (study vaccine) | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Bronchiolitis | 5 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Conjunctivitis | 27 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Furuncle | 8 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Gastroenteritis | 13 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Impetigo | 5 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Nasopharyngitis | 19 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Atypical pneumonia | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Sepsis | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Otitis media--acute | 5 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Pneumonia | 8 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Tinea infection | 31 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Upper respiratory tract infection | 64 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Cough | 12 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Diaper dermatitis | 4 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Papular rash | 5 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Serious Adverse Event (SAE): Diarrhea | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Gastroenteritis | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Bronchiolitis | 3 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Cough | 7 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Diarrhea | 19 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Sepsis | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Pyrexia | 3 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Nasopharyngitis | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site reaction (routine vaccines) | 4 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Serious Adverse Event (SAE): Diarrhea | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site swelling (routine vaccines) | 61 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Otitis media--acute | 4 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Vaccination site swelling (study vaccine) | 6 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Diaper dermatitis | 5 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Bronchiolitis | 6 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Pneumonia | 8 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Conjunctivitis | 19 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Bronchiolitis | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Furuncle | 6 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Tinea infection | 21 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Gastroenteritis | 10 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Papular rash | 8 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Impetigo | 4 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | Upper respiratory tract infection | 48 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Gastroenteritis | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of All Adverse Events in Infants | SAE: Atypical pneumonia | 0 Participants |
Primary
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia.
Time frame: 7 days after vaccination
Population: This table displays vaccinated adults and toddlers only. Infants had laboratory tests only at screening.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | None | 16 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Moderate | 1 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Moderate | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Mild | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | None | 17 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Severe | 0 Participants |
| Adults--PCV10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Severe | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Moderate | 1 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | None | 16 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | None | 17 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Mild | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Moderate | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Severe | 0 Participants |
| Adults--Pneumovax 23 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | None | 17 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | None | 55 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Mild | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Moderate | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | None | 55 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Moderate | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Severe | 5 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | None | 51 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | None | 55 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | None | 56 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Severe | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Mild | 0 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Moderate | 1 Participants |
| Toddler--PCV 10 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Severe | 10 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | Moderate | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | None | 46 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--not related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--vaccine related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased WBCs--not related | None | 55 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | Mild | 1 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--vaccine related | Severe | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased WBCs--vaccine related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased hemoglobin--not related | Mild | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | None | 56 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--not related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Decreased platelets--vaccine related | None | 55 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--not related | Moderate | 0 Participants |
| Toddler--Prevenar 13 | Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers | Increased ALT--vaccine related | Moderate | 0 Participants |
Secondary
Functional Antibody (OPA) Geometric Mean Titers
The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.
Time frame: 4 weeks after last vaccination
Population: Randomly selected subsets of the infant and toddler cohorts and all adult subjects
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 18.89 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 3928.12 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 3564.32 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 9148.12 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 263.06 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 3170.33 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 17161.52 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 13303.68 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 5035.73 titer |
| Adults--PCV10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 7099.73 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 265.56 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 85.89 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 8019.15 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 4925.68 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 2215.22 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 2844.04 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 4443.95 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 2481.47 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 4221.68 titer |
| Adults--Pneumovax 23 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 6707.26 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 8213.23 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 1358.22 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 3036.60 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 8768.08 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 12415.92 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 3770.19 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 1789.98 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 19371.45 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 10723.98 titer |
| Toddler--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 436.31 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 2557.27 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 3780.56 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 1148.43 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 12001.09 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 7066.76 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 438.14 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 12737.21 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 4862.30 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 3371.52 titer |
| Toddler--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 10517.81 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 744.92 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 50.65 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 876.58 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 113.92 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 1243.88 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 1530.37 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 197.24 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 1243.39 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 151.31 titer |
| Infant--PCV 10 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 627.27 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 14 | 1108.02 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 9V | 752.77 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 7F | 3763.17 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19F | 498.98 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 6B | 2267.44 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 6A | 3068.16 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 5 | 104.83 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - Pn 1 | 29.42 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 23F | 921.43 titer |
| Infant--Prevenar 13 | Functional Antibody (OPA) Geometric Mean Titers | MOPA - 19A | 765.71 titer |
Secondary
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time frame: 4 weeks after the third dose
Population: All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 23F | 1.56 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 1 | 2.99 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 5 | 2.09 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 6A | 1.02 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 6B | 1.57 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 7F | 2.19 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 9V | 1.07 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 14 | 4.96 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 19A | 1.49 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 19F | 3.87 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 14 | 4.47 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 23F | 2.68 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 7F | 3.88 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 1 | 3.38 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 19F | 5.38 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 5 | 1.74 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 9V | 2.19 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 6A | 1.82 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 19A | 5.20 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants | PnC-IgG-ELISA type 6B | 3.64 µg/mL |
p-value: 0.25590% CI: [0.74, 1.06]t-test, 2 sided
p-value: 0.086590% CI: [1.01, 1.43]t-test, 2 sided
p-value: 0.000690% CI: [0.43, 0.74]t-test, 2 sided
p-value: <0.000190% CI: [0.33, 0.57]t-test, 2 sided
p-value: <0.000190% CI: [0.47, 0.68]t-test, 2 sided
p-value: <0.000190% CI: [0.41, 0.59]t-test, 2 sided
p-value: 0.523490% CI: [0.85, 1.45]t-test, 2 sided
p-value: <0.000190% CI: [0.22, 0.36]t-test, 2 sided
p-value: 0.00490% CI: [0.6, 0.87]t-test, 2 sided
p-value: 0.000190% CI: [0.46, 0.73]t-test, 2 sided
Secondary
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time frame: 4 weeks after vaccination
Population: All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 1: Baseline | 0.77 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 1: Post-vaccination | 4.59 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 5: Baseline | 0.60 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 5: Post-vaccination | 2.30 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6A: Baseline | 1.40 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6A: Post-vaccination | 13.33 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6B: Baseline | 2.02 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6B: Post-vaccination | 15.77 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 7F: Baseline | 1.49 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 7F: Post-vaccination | 9.17 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 9V: Baseline | 0.53 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 9V: Post-vaccination | 2.35 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 14: Baseline | 2.89 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 14: Post-vaccination | 14.55 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19A: Baseline | 1.17 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19A: Post-vaccination | 9.76 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19F: Baseline | 1.75 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19F: Post-vaccination | 9.75 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 23F: Baseline | 0.71 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 23F: Post-vaccination | 6.84 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19F: Post-vaccination | 12.87 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 1: Baseline | 0.92 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 9V: Baseline | 0.41 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 1: Post-vaccination | 6.09 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19A: Post-vaccination | 13.68 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 5: Baseline | 0.42 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 9V: Post-vaccination | 3.90 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 5: Post-vaccination | 3.35 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 23F: Post-vaccination | 10.49 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6A: Baseline | 1.29 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 14: Baseline | 2.47 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6A: Post-vaccination | 15.83 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19F: Baseline | 0.97 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6B: Baseline | 1.95 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 14: Post-vaccination | 8.28 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 6B: Post-vaccination | 19.16 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 23F: Baseline | 0.63 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 7F: Baseline | 1.46 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 19A: Baseline | 0.57 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers | PnC-IgG-ELISA type 7F: Post-vaccination | 12.35 µg/mL |
p-value: 0.265390% CI: [0.54, 1.31]Two-tailed from z-test
p-value: 0.205990% CI: [0.45, 1.2]Two-tailed from z-test
p-value: 0.566490% CI: [0.55, 1.54]Two-tailed from z-test
p-value: 0.445690% CI: [0.57, 1.31]Two-tailed from z-test
p-value: 0.218990% CI: [0.52, 1.14]Two-tailed from z-test
p-value: 0.09790% CI: [0.38, 1.03]Two-tailed from z-test
p-value: 0.071390% CI: [1.02, 2.79]Two-tailed from z-test
p-value: 0.344390% CI: [0.42, 1.35]Two-tailed from z-test
p-value: 0.327890% CI: [0.48, 1.23]Two-tailed from z-test
p-value: 0.203990% CI: [0.4, 1.16]Two-tailed from z-test
Secondary
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time frame: 4 weeks after vaccination
Population: All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 6A | 17.09 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 9V | 4.92 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 5 | 3.56 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 14 | 48.23 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 6B | 26.87 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 1 | 3.96 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 19F | 20.72 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 7F | 4.62 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 23F | 10.09 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 19A | 19.47 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 23F | 8.95 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 1 | 12.79 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 5 | 4.80 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 6A | 3.64 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 6B | 12.12 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 7F | 6.07 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 9V | 8.73 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 14 | 44.78 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 19A | 11.20 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults | PnC-IgG-ELISA type 19F | 12.38 µg/mL |
p-value: 0.002590% CI: [0.17, 0.57]t-test, 2 sided
p-value: 0.45490% CI: [0.38, 1.45]t-test, 2 sided
p-value: 0.000390% CI: [2.46, 8.94]t-test, 2 sided
p-value: 0.04690% CI: [1.16, 4.24]t-test, 2 sided
p-value: 0.336590% CI: [0.47, 1.22]t-test, 2 sided
p-value: 0.031390% CI: [0.37, 0.87]t-test, 2 sided
p-value: 0.80690% CI: [0.65, 1.79]t-test, 2 sided
p-value: 0.204490% CI: [0.84, 3.58]t-test, 2 sided
p-value: 0.14990% CI: [0.93, 3.02]t-test, 2 sided
p-value: 0.756590% CI: [0.59, 2.15]t-test, 2 sided
Secondary
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort.
Time frame: 4 weeks after vaccination (28 days)
Population: The evaluable group differs for individual serotypes due to non-reportable results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 9V | 4.43 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 5 | 3.82 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 14 | 5.04 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 6B | 7.79 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 19A | 7.89 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 1 | 5.99 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 19F | 5.73 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 7F | 6.16 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 23F | 9.67 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 6A | 9.91 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 23F | 16.54 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 5 | 8.00 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 6A | 12.31 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 6B | 9.82 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 7F | 8.44 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 9V | 9.58 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 14 | 3.35 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 19A | 24.17 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 19F | 13.26 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype | PnC-IgG-ELISA type 1 | 6.59 fold change |
Secondary
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.
Time frame: 84 days
Population: Randomly selected subsets of the infant cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 1 | 15 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 5 | 19 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 6A | 20 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 6B | 19 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 7F | 20 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 9V | 20 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 14 | 19 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 19A | 16 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 19F | 20 Participants |
| Adults--PCV10 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 23F | 20 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 19A | 20 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 1 | 11 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 9V | 20 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 5 | 19 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 23F | 20 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - Pn 6A | 18 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 14 | 18 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 6B | 19 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 19F | 19 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype | MOPA - 7F | 20 Participants |
90% CI: [-15.55, 36.11]
90% CI: [-18.56, 18.56]
90% CI: [-12.35, 22.97]
90% CI: [-12.15, 24.01]
90% CI: [-26.41, 11.01]
90% CI: [-11.64, 22.97]
Secondary
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for: * Diptheria toxoid: 0.1 IU/mL * Hepatitis B: 10 milli-International unit (mIU) /mL * Hib: 0.15 mcg/mL * Tetanus toxoid: 0.1 IU/mL
Time frame: 84 days
Population: All subjects who receive all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Diphtheria toxoid | 100 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Hepatitis B | 100 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Hib (anti-PRP antibodies) | 100 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Tetanus toxoid | 100 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Tetanus toxoid | 100 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Diphtheria toxoid | 100 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Hib (anti-PRP antibodies) | 99 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components | Hepatitis B | 100 Participants |
Secondary
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.
Time frame: 4 weeks after third dose
Population: All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 6A | 79 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 9V | 94 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 5 | 100 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 14 | 98 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 6B | 89 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 19A | 92 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 1 | 99 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 19F | 99 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 23F | 91 Participants |
| Adults--PCV10 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 7F | 97 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 23F | 97 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 1 | 100 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 5 | 97 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 6A | 91 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 6B | 93 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 7F | 100 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 9V | 97 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 14 | 96 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 19A | 94 Participants |
| Adults--Pneumovax 23 | Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype | Pn-IgG-ELISA type 19F | 97 Participants |
90% CI: [-5.13, 2.66]
90% CI: [-1.1, 7.95]
90% CI: [-20.94, -2.97]
90% CI: [-15, -1.01]
90% CI: [-7.95, 1.1]
90% CI: [-9.17, 2.9]
90% CI: [-4, 6.27]
90% CI: [-12.38, 0.17]
90% CI: [-4.22, 4.33]
90% CI: [-12.77, 0.4]
Other Pre-specified
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer.
Time frame: 20-23 weeks
Population: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 0.17 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 0.08 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 0.19 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 0.52 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 0.22 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 0.10 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 0.17 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 0.25 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 0.17 concentration ratio |
| Adults--PCV10 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 0.43 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 0.08 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 0.17 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 0.34 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 0.14 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 0.24 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 0.10 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 0.41 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 0.12 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 0.13 concentration ratio |
| Adults--Pneumovax 23 | Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 0.10 concentration ratio |
Other Pre-specified
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer.
Time frame: 24-26 weeks
Population: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 1.14 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 3.40 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 2.34 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 2.31 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 8.93 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 1.87 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 4.96 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 2.09 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 3.78 concentration ratio |
| Adults--PCV10 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 9.18 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 2.42 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 2.57 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 1.58 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 1.77 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 7.75 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 3.83 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 2.48 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 1.46 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 2.97 concentration ratio |
| Adults--Pneumovax 23 | Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 2.05 concentration ratio |
Other Pre-specified
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants.
Time frame: 4 weeks (28 days)
Population: This is the population of infants who received a booster dose of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Post Booster | 9.50 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Post Booster | 5.11 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Post Booster | 2.44 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: 4 weeks post Vac 3 | 1.39 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: 4 weeks post Vac 3 | 3.70 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Pre Booster | 0.18 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Pre Booster | 0.73 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Post Booster | 6.24 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: 4 weeks post Vac 3 | 1.06 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Post Booster | 12.72 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Pre Booster | 0.23 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Post Booster | 6.76 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: 4 weeks post Vac 3 | 1.99 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Post Booster | 6.72 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Pre Booster | 0.49 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: 4 weeks post Vac 3 | 2.01 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Post Booster | 7.73 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Pre Booster | 0.29 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: Pre Booster | 0.16 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: 4 weeks post Vac 3 | 2.67 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: 4 weeks post Vac 3 | 1.35 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | ELISA Type 5: Post Booster | 2.30 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: 4 weeks post Vac 3 | 1.35 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Post Booster | 8.16 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: 4 weeks post Vac 3 | 1.06 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Pre Booster | 0.63 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Pre Booster | 0.81 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Pre Booster | 0.46 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Pre Booster | 0.27 µg/mL |
| Adults--PCV10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: 4 weeks post Vac 3 | 4.38 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Post Booster | 5.28 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Pre Booster | 0.17 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: 4 weeks post Vac 3 | 3.23 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Pre Booster | 0.32 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Post Booster | 5.11 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: 4 weeks post Vac 3 | 1.45 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: Pre Booster | 0.25 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | ELISA Type 5: Post Booster | 2.57 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: 4 weeks post Vac 3 | 1.56 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Pre Booster | 0.53 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Post Booster | 12.06 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: 4 weeks post Vac 3 | 3.67 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Pre Booster | 0.50 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Post Booster | 14.06 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: 4 weeks post Vac 3 | 3.43 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Pre Booster | 0.81 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Post Booster | 8.51 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: 4 weeks post Vac 3 | 2.22 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Pre Booster | 0.22 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Post Booster | 3.23 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Pre Booster | 1.52 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Post Booster | 7.60 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: 4 weeks post Vac 3 | 5.12 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Pre Booster | 0.59 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Post Booster | 15.20 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: 4 weeks post Vac 3 | 4.61 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Pre Booster | 0.59 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Post Booster | 11.85 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: 4 weeks post Vac 3 | 2.18 µg/mL |
| Adults--Pneumovax 23 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: 4 weeks post Vac 3 | 3.71 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Pre Booster | 0.87 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: 4 weeks post Vac 3 | 0.68 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: 4 weeks post Vac 3 | 0.62 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Pre Booster | 0.53 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | ELISA Type 5: Post Booster | 0.90 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Pre Booster | 1.07 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: Post Booster | 1.07 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: Pre Booster | 0.62 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Post Booster | 0.97 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: 4 weeks post Vac 3 | 0.26 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 5: 4 weeks post Vac 3 | 1.38 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 23F: Pre Booster | 1.32 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Pre Booster | 0.49 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Post Booster | 1.22 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: Post Booster | 0.65 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: 4 weeks post Vac 3 | 0.58 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19A: Post Booster | 0.44 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Pre Booster | 0.61 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Post Booster | 0.91 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: Pre Booster | 0.83 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 7F: Post Booster | 0.79 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: Pre Booster | 1.45 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 14: 4 weeks post Vac 3 | 1.18 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: 4 weeks post Vac 3 | 0.48 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6B: 4 weeks post Vac 3 | 0.38 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 19F: 4 weeks post Vac 3 | 0.80 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Pre Booster | 0.83 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 6A: Post Booster | 0.79 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 1: 4 weeks post Vac 3 | 0.83 µg/mL |
| Toddler--PCV 10 | Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose | PnC-IgG-ELISA Type 9V: Post Booster | 0.76 µg/mL |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants.
Time frame: 4 weeks (28 days)
Population: This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 10.03 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 17.81 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 23.20 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 14.83 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 12.44 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 20.70 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 22.10 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 13.37 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 22.52 fold change |
| Adults--PCV10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 13.48 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 15.75 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 22.98 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 4.99 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 25.73 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 15.02 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 10.44 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 20.60 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 10.17 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 30.75 fold change |
| Adults--Pneumovax 23 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 28.66 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 23F | 0.72 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 1 | 1.43 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 5 | 1.46 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6B | 0.62 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 7F | 1.28 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 9V | 0.90 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 14 | 2.01 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19A | 0.90 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA Type 19F | 0.60 fold change |
| Toddler--PCV 10 | Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose | PnC-IgG-ELISA type 6A | 0.90 fold change |
Other Pre-specified
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 30 (± 10) minutes following booster vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following the vaccination
Time frame: 7 days
Population: A subset of the infant cohort who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 1 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 1 | 3 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 3 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | None reported/normal (temp) | 43 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 1 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | None reported/normal (temp) | 48 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 1 | 5 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | None reported/normal (temp) | 44 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 1 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | None reported/normal (temp) | 48 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | None reported/normal (temp) | 47 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 1 | 8 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 2 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | None reported/normal (temp) | 40 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 1 | 1 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 2 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | None reported/normal (temp) | 48 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 1 | 4 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 2 | 2 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 3 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 4 | 0 Participants |
| Adults--PCV10 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | None reported/normal (temp) | 43 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | None reported/normal (temp) | 46 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 1 | 5 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 1 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 1 | 4 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 2 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 1 | 4 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 3 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Temperature above 37 C | None reported/normal (temp) | 41 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 1 | 3 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | None reported/normal (temp) | 43 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 2 | 2 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Decreased appetite | None reported/normal (temp) | 42 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Cutaneous Rash | None reported/normal (temp) | 42 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 1 | 11 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 1 | 7 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Irritability | None reported/normal (temp) | 40 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Induration/Swelling | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 1 | 1 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Erythema | None reported/normal (temp) | 46 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Drowsiness | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity | Injection site tenderness | None reported/normal (temp) | 36 Participants |
Other Pre-specified
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated.
Time frame: 4 weeks (28 days)
Population: A subset of the infant cohort PP\_IMM who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | None reported | 48 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 1 | 14 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | None reported | 35 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 1 | 4 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | None reported | 45 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 1 | 2 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | None reported | 47 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 1 | 3 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | None reported | 46 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 1 | 1 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | None reported | 48 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 1 | 1 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 3 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 4 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | None reported | 48 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 1 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 2 | 0 Participants |
| Adults--PCV10 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 3 | 1 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | None reported | 44 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | None reported | 47 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 1 | 3 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 1 | 6 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Upper respiratory tract infection | None reported | 41 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | None reported | 44 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 1 | 3 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 1 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 1 | 4 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Dermatitis | None reported | 44 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 1 | 5 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Pyrexia | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 3 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | Grade 4 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | SAE--severe malaria with severe anemia | Grade 2 | 0 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Diarrhea | None reported | 42 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Rash pustular | None reported | 43 Participants |
| Adults--Pneumovax 23 | Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity | Impetigo | Grade 1 | 3 Participants |