Vaccines
Conditions
Brief summary
A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Detailed description
A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Interventions
BIOLOGICAL13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 72 Days
Healthy volunteers
Yes
Inclusion criteria
1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study. 2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures. 3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.) 4. Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone. 5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 6. Weight of 3.0 kg or greater at the time of vaccination.
Exclusion criteria
1. Infant who is a direct descendant (child, grandchild) of * Investigator site staff members directly involved in the conduct of the study, or * Site staff members otherwise supervised by the investigator, or * Pfizer employees directly involved in the conduct of the study. 2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable. 3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine. 4. A previous anaphylactic reaction to any vaccine or vaccine-related component. 5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection. 7. Major known congenital malformation or serious chronic disorder. 8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb's palsy. 9. Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4 | From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months) | A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Within 7 days after Vaccination 2 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Within 7 days after Vaccination 3 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Within 7 days after Vaccination 3 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Within 7 days after Vaccination 4 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Within 7 days after Vaccination 4 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. |
| Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3 | From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. |
| Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4 | From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. |
| Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4 | From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Within 7 days after Vaccination 1 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Within 7 days after Vaccination 1 | Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (\<)38.0 degrees Celsius \[C\], 2)greater than or equal to(\>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here,Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Within 7 days after Vaccination 2 | Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | 1 month after Vaccination 4 | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported. |
| Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | 1 month after Vaccination 3 | Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. |
| Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | 1 month after Vaccination 4 | Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported. |
| Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | 1 month after Vaccination 3 | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. |
| Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | 1 month after Vaccination 4 | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs. |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | 1 month after Vaccination 3 | Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | 1 month after Vaccination 4 | Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13. |
| Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | 1 month after Vaccination 3 | Percentage of participants achieving predefined antibody threshold: \>=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC with preservative 2-PE from a MDV, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine with preservative 2-PE from MDV, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | 150 |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) Infant series: participants were randomized to receive a single 0.5 mL dose of 13vPnC without preservative 2-PE from a single-dose PFS, intramuscularly at age of 6 weeks (Vaccination 1), 10 weeks (Vaccination 2) and 14 weeks (Vaccination 3) along with 2 routine vaccines: 1) DTP-Hib-HBV vaccine, 2) rotavirus vaccine. Participants were followed-up to 1 month after Vaccination 3. Infant series was followed by toddler dose. Toddler dose: participants were administered with a single 0.5 mL dose of 13vPnC vaccine without preservative 2-PE from single dose PFS, intramuscularly at age of 12 months (Vaccination 4) along with routine hepatitis A virus vaccine. Participants were followed-up to 1 month after Vaccination 4. Different limbs were used to administer study vaccine and routine vaccines (according to local clinical practice). | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Infant Series | Adverse Event | 0 | 2 |
| Infant Series | Lost to Follow-up | 2 | 1 |
| Infant Series | No Longer Met Eligibility Criteria | 1 | 0 |
| Infant Series | Randomized but Not Vaccinated | 1 | 0 |
| Infant Series | Withdrawal by Parent/Guardian | 8 | 8 |
| Toddler Dose | Withdrawal by parent/guardian | 1 | 1 |
Baseline characteristics
| Characteristic | 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Total | 13vPnC: Multi-dose Vial (With Preservative) |
|---|---|---|---|
| Age, Continuous | 6.9 Weeks STANDARD_DEVIATION 0.99 | 6.9 Weeks STANDARD_DEVIATION 0.97 | 6.9 Weeks STANDARD_DEVIATION 0.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants | 300 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 150 Participants | 300 Participants | 150 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 67 Participants | 141 Participants | 74 Participants |
| Sex: Female, Male Male | 83 Participants | 159 Participants | 76 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 139 | 0 / 139 |
| other Total, other adverse events | 145 / 150 | 141 / 150 | 0 / 0 | 0 / 0 | 58 / 139 | 54 / 139 |
| serious Total, serious adverse events | 5 / 150 | 4 / 150 | 6 / 150 | 3 / 150 | 1 / 139 | 0 / 139 |
Outcome results
Primary
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
Population: Safety population for study included all participants who received at least 1 dose of study vaccine in study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4 | 0 Participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4 | 0 Participants |
Primary
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Time frame: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3 | 47.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3 | 49.3 percentage of participants |
Primary
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Time frame: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4 | 7.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4 | 8.6 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 1
Population: Safety population of infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Any | 27.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Any | 61.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Mild | 28.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 21.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Severe | 2.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Any | 19.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Moderate | 30.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 2.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 6.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 17.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Moderate | 29.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Severe | 5.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Any | 33.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 23.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 10.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Any | 67.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Mild | 33.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 12.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 4.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Any | 16.9 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 2
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Any | 17.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 16.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 0.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Any | 24.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 21.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 3.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Any | 59.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Mild | 32.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Moderate | 20.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Severe | 6.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Moderate | 26.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Any | 19.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 5.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 17.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Mild | 29.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 1.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Severe | 6.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Any | 27.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Any | 62.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 22.9 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 3
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Mild | 20.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Moderate | 2.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Any | 20.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Any | 55.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Any | 23.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Mild | 30.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Moderate | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Moderate | 23.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Mild | 20.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Severe | 2.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Severe | 5.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Any | 22.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Mild | 20.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Moderate | 2.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Any | 27.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Mild | 23.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Moderate | 2.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Swelling: Severe | 0.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Any | 54.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Mild | 27.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Pain at injection site: Moderate | 21.4 percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, Any for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 4
Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Mild | 6.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Any | 25.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Any | 8.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Moderate | 2.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: MIld | 8.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Mild | 18.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Moderate | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Moderate | 6.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Any | 9.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Moderate | 0.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Any | 12.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Mild | 11.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Swelling: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Any | 19.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Mild | 13.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Moderate | 5.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Pain at injection site: Severe | 0.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Any | 11.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: MIld | 10.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Moderate | 0.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Redness: Severe | 0 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
Population: Safety population included all participants who received at least 1 dose of study vaccine in study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4 | 8.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4 | 4.7 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (\<)38.0 degrees Celsius \[C\], 2)greater than or equal to(\>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here,Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 1
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: <38.0 degree C | 15.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: 39.0 degree C to 40.0 degree C | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 degree C | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Any | 42.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Mild | 23.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Moderate | 17.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Severe | 0.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Any | 55.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Mild | 29.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 degree C to 38.4 degree C | 10.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: 38.5 degree C to 38.9 degree C | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Moderate | 25.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Severe | 0.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Any | 64.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Mild | 37.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Moderate | 21.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Severe | 5.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Severe | 6.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: <38.0 degree C | 10.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 degree C to 38.4 degree C | 8.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: 39.0 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Any | 65.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: 38.5 degree C to 38.9 degree C | 2.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Any | 53.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Mild | 33.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Mild | 30.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Moderate | 26.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Moderate | 21.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Moderate | 31.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Severe | 1.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Mild | 32.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Any | 66.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Drowsiness: Severe | 2.0 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 2
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 degree C to 38.4 degree C | 6.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Any | 50.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Any | 40.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Mild | 23.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: 39.0 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Moderate | 25.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Mild | 27.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Severe | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: 38.5 degree C to 38.9 degree C | 2.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Any | 56.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Moderate | 12.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Mild | 29.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Moderate | 24.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Severe | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Severe | 2.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: <38.0 degree C | 8.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Severe | 4.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: <38.0 degree C | 8.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 degree C to 38.4 degree C | 5.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: 38.5 degree C to 38.9 degree C | 2.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: 39.0 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >40.0 degree C | 0.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Any | 38.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Mild | 25.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Moderate | 12.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Severe | 1.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Any | 52.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Mild | 22.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Moderate | 26.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Drowsiness: Severe | 3.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Any | 60.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Mild | 37.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Moderate | 17.9 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 3
Population: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: >=38.0 degree C to 38.4 degree C | 4.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Any | 34.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Moderate | 13.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Mild | 20.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: 38.5 degree C to 38.9 degree C | 2.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Moderate | 11.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: <38.0 degree C | 7.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Severe | 2.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: 39.0 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Any | 36.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Any | 54.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Mild | 20.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Severe | 1.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Mild | 31.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Moderate | 19.4 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Severe | 3.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: >40.0 degree C | 0.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Severe | 6.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Moderate | 17.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Severe | 2.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Any | 60.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Mild | 37.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Irritability: Moderate | 15.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: <38.0 degree C | 9.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: >=38.0 degree C to 38.4 degree C | 6.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: 38.5 degree C to 38.9 degree C | 1.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: 39.0 degree C to 40.0 degree C | 1.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Any | 36.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Mild | 23.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Moderate | 10.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Decreased appetite: Severe | 2.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Any | 39.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Drowsiness: Mild | 19.3 percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, Any for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 4
Population: Safety population for toddler dose included all participants who received at least 1 dose of study vaccine during toddler dosing. Here, Overall Number of Participants Analyzed, N signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: <38.0 degree C | 3.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: >=38.0 degree C to 38.4 degree C | 1.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: 38.5 degree C to 38.9 degree C | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: 39.0 degree C to 40.0 degree C | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: >40.0 degree C | 1.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Any | 15.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Mild | 10.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Mild | 3.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Moderate | 3.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Severe | 0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Any | 24.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Moderate | 7.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Moderate | 4.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Any | 7.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Mild | 15.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Severe | 0.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Moderate | 5.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: <38.0 degree C | 4.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Mild | 12.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: >=38.0 degree C to 38.4 degree C | 3.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Any | 18.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: 38.5 degree C to 38.9 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Moderate | 6.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: 39.0 degree C to 40.0 degree C | 0.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Drowsiness: Severe | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Fever: >40.0 degree C | 0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Any | 23.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Any | 16.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Severe | 1.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Mild | 6.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Moderate | 9.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Irritability: Mild | 16.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Decreased appetite: Severe | 0 percentage of participants |
Secondary
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Time frame: 1 month after Vaccination 3
Population: Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post-Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 2.89 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 1.45 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 1.67 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 2.01 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 2.33 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 1.42 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 1.01 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 1.66 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 0.41 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 1.81 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 0.83 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 1.48 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 1.36 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 0.94 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 0.93 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 0.33 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 1.86 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 2.43 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 1.13 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 1.75 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 0.86 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 0.86 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 1.85 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 1.28 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 1.39 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 1.37 mcg/mL |
Secondary
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Time frame: 1 month after Vaccination 4
Population: Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 10.89 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 4.35 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 1.58 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 10.58 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 5.16 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 11.76 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 7.92 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 8.78 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 13.20 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 6.21 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 12.26 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 13.65 mcg/mL |
| 13vPnC: Multi-dose Vial (With Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 18.55 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 12.02 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 9.90 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 8.29 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 4.27 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 6.27 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 1.63 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 9.57 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 11.91 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 14.09 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 5.68 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 20.51 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 11.78 mcg/mL |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 10.87 mcg/mL |
Secondary
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Time frame: 1 month after Vaccination 4
Population: Evaluable immunogenicity population for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 4161.5 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 6927.5 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 157.6 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 1505.8 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 204.2 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 8028.3 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 2945.7 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 1848.9 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 2991.4 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 808.0 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 1948.9 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 3125.0 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 121.0 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 3348.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 217.0 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 129.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 2519.0 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 153.4 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 3092.5 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 1750.1 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 6460.4 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 1302.2 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 7830.0 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 1832.5 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 766.0 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 4353.8 titer (1/dilution) |
Secondary
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Time frame: 1 month after Vaccination 3
Population: Evaluable immunogenicity population for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days (inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 37.0 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 643.9 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 79.7 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 496.9 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 1211.7 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 3055.8 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 21.8 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 219.3 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 1145.8 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 236.1 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 1158.8 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 1036.4 titer (1/dilution) |
| 13vPnC: Multi-dose Vial (With Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 1743.3 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 926.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 22.5 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 72.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 40.9 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 1321.9 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 957.6 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 1178.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 683.3 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 341.8 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 2183.9 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 275.7 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 272.7 titer (1/dilution) |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 1159.2 titer (1/dilution) |
Secondary
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving predefined antibody threshold: \>=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported.
Time frame: 1 month after Vaccination 3
Population: Evaluable immunogenicity population(EIP) for infant series: all eligible participants aged 6 weeks at time of Dose 1, who received 3 doses of infant series vaccine, had blood drawn post Dose 3 within 27 to 56 days(inclusive) post Dose 3, had at least 1 valid and determinate assay result post Dose 3, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 84.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 84.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 96.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 88.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 97.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 91.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 91.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 83.8 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 77.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 85.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 92.6 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 91.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 98.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 91.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 85.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 82.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 75.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 84.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 93.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 85.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 82.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 83.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 71.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 95.5 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 76.7 percentage of participants |
Secondary
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported.
Time frame: 1 month after Vaccination 4
Population: EIP for toddler dose: all eligible participants who received 3 doses in infant series and 1 toddler dose of vaccine, had blood drawn post Dose 4 within 27 to 56 days (inclusive) post Dose 4, had at least 1 valid and determinate assay result post Dose 4, and had no major protocol violations. N: signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 98.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 99.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 99.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 96.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 99.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 98.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 99.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 97.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 98.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 97.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 97.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 99.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 99.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 96.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 96.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 96.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 99.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 99.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 98.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 96.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 99.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 99.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Time frame: 1 month after Vaccination 3
Population: Evaluable immunogenicity population for infant series was analyzed. Overall Number of Participants Analyzed: signifies participants evaluable for this outcome measure. Number Analyzed: signifies participants evaluable for specific serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 98.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 88.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 91.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 82.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 98.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 98.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 94.5 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 92.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 62.3 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 89.7 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 99.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 94.9 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 51.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 23F | 94.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 1 | 46.2 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 3 | 98.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 4 | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 5 | 62.6 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6A | 94.4 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 6B | 92.3 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 7F | 96.8 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 9V | 88.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 14 | 76.9 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 18C | 98.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19A | 95.7 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3 | Serotype: 19F | 91.4 percentage of participants |
Secondary
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Time frame: 1 month after Vaccination 4
Population: Evaluable immunogenicity population for toddler dose was analyzed. Overall Number of Participants Analyzed: signifies participants evaluable for this outcome measure. Number Analyzed: signifies participants evaluable for specific serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 95.2 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 97.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 99.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 98.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 96.1 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 100.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 99.0 percentage of participants |
| 13vPnC: Multi-dose Vial (With Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 97.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 23F | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 1 | 97.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 3 | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 4 | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 5 | 97.1 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6A | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 6B | 95.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 7F | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 9V | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 14 | 100.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 18C | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19A | 99.0 percentage of participants |
| 13vPnC: Single-dose Prefilled Syringe (Without Preservative) | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4 | Serotype: 19F | 97.0 percentage of participants |