Pneumococcal Disease
Conditions
Brief summary
The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.
Interventions
Sponsors
Study design
Intervention model description
Parallel Assignment
Eligibility
Inclusion criteria
* Male or female participants ≥18 and ≤49 years of age at the time of consent * Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention * Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine * Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study * Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study * Known or suspected immunodeficiency or other conditions associated with immunosuppression * Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation * Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Within 7 days after study intervention | Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Within 7 days after study intervention | Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | Within 1 month after study intervention | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | Within 1 month after study intervention | An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 1 month after study intervention | GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 17 sites in the United States.
Pre-assignment details
A total of 394 participants were enrolled and randomized in the study of which 3 participants were not vaccinated and, 391 were administered study intervention. One participant randomized to Candidate-Control received Candidate-4.
Participants by arm
| Arm | Count |
|---|---|
| Candidate-1 Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 41 |
| Candidate-2 Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 42 |
| Candidate-3 Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 39 |
| Candidate-4 Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 44 |
| Candidate-5 Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 45 |
| Candidate-6 Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 46 |
| Candidate - Control Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 45 |
| PCV15 Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 43 |
| 13vPnC Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention. | 46 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Candidate-1 | Candidate-2 | Candidate-3 | Candidate-4 | Candidate-5 | Candidate-6 | Candidate - Control | PCV15 | 13vPnC | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.9 Years STANDARD_DEVIATION 9.15 | 35.2 Years STANDARD_DEVIATION 9.11 | 35.3 Years STANDARD_DEVIATION 9.44 | 33.2 Years STANDARD_DEVIATION 9.39 | 33.3 Years STANDARD_DEVIATION 9.29 | 35.2 Years STANDARD_DEVIATION 8.35 | 34.1 Years STANDARD_DEVIATION 7.68 | 35.6 Years STANDARD_DEVIATION 8.86 | 35.7 Years STANDARD_DEVIATION 7.38 | 34.8 Years STANDARD_DEVIATION 8.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 15 Participants | 12 Participants | 12 Participants | 12 Participants | 20 Participants | 14 Participants | 14 Participants | 16 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 27 Participants | 27 Participants | 32 Participants | 33 Participants | 26 Participants | 31 Participants | 29 Participants | 30 Participants | 262 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 4 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 4 Participants | 8 Participants | 8 Participants | 5 Participants | 6 Participants | 9 Participants | 7 Participants | 8 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 25 Participants | 35 Participants | 26 Participants | 32 Participants | 36 Participants | 37 Participants | 30 Participants | 33 Participants | 32 Participants | 286 Participants |
| Sex: Female, Male Female | 30 Participants | 26 Participants | 27 Participants | 24 Participants | 26 Participants | 25 Participants | 27 Participants | 19 Participants | 23 Participants | 227 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 12 Participants | 20 Participants | 19 Participants | 21 Participants | 18 Participants | 24 Participants | 23 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 | 0 / 39 | 0 / 44 | 0 / 45 | 0 / 46 | 0 / 45 | 0 / 43 | 0 / 46 |
| other Total, other adverse events | 25 / 41 | 27 / 42 | 21 / 39 | 28 / 44 | 30 / 45 | 30 / 46 | 22 / 45 | 32 / 43 | 37 / 46 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 | 0 / 39 | 0 / 44 | 1 / 45 | 0 / 46 | 0 / 45 | 0 / 43 | 0 / 46 |
Outcome results
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 1 month after study intervention
Population: Safety population included all participants who received the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candidate-1 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 4.8 Percentage of participants |
| Candidate-3 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 5.1 Percentage of participants |
| Candidate-4 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 8.9 Percentage of participants |
| Candidate-6 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 4.3 Percentage of participants |
| Candidate - Control | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 2.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention | 2.2 Percentage of participants |
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Time frame: Within 7 days after study intervention
Population: Safety population included all participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 12.2 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 4.8 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 26.2 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 20.5 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 2.6 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 2.3 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 2.3 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 25.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 2.3 Percentage of participants |
| Candidate-4 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 2.2 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 2.2 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 2.2 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 2.2 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 37.8 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 6.7 Percentage of participants |
| Candidate-5 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 4.3 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 6.5 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 17.4 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 0.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 23.9 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 11.1 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 2.2 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 4.7 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 4.7 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 30.2 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 4.7 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 4.7 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 37.2 Percentage of participants |
| PCV15 | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Moderate | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Severe | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Severe | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Mild | 54.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Moderate | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Moderate | 6.5 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Redness: Mild | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Pain At Injection Site: Severe | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention | Swelling: Mild | 8.7 Percentage of participants |
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 1 month after study intervention
Population: Safety population included all participants who received the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candidate-1 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention | 0.0 Percentage of participants |
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after study intervention
Population: Safety population included all participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 17.1 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 2.4 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 14.6 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 34.1 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 7.3 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 2.4 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 12.2 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 2.4 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 0.0 Percentage of participants |
| Candidate-1 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 14.3 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 9.5 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 11.9 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 19.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 7.1 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 23.8 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 4.8 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 0.0 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 2.4 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 26.2 Percentage of participants |
| Candidate-2 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 12.8 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 5.1 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 12.8 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 12.8 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 20.5 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 25.6 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| Candidate-3 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 2.6 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 9.1 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 9.1 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 13.6 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 2.3 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 25.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 4.5 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 18.2 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 9.1 Percentage of participants |
| Candidate-4 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 13.6 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 31.1 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 6.7 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 4.4 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 13.3 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 11.1 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 2.2 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 4.4 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 8.9 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 20.0 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 4.4 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 6.7 Percentage of participants |
| Candidate-5 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 6.5 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 21.7 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 19.6 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 4.3 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 17.4 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 6.5 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 13.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 13.0 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 2.2 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 4.3 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 10.9 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 4.3 Percentage of participants |
| Candidate-6 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 2.2 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 4.4 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 11.1 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 2.2 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 6.7 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 0.0 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 15.6 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 2.2 Percentage of participants |
| Candidate - Control | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 22.2 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 11.6 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 14.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 18.6 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 2.3 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 30.2 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 9.3 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 11.6 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 20.9 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 0.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 2.3 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 7.0 Percentage of participants |
| PCV15 | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 14.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Moderate | 13.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >40.0 degrees C | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Severe | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Moderate | 13.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Moderate | 10.9 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.9 degrees C to 40.0 degrees C | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Severe | 8.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Mild | 17.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >/=38.0 degrees C to 38.4 degrees C | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Mild | 21.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fever: >38.4 degrees C to 38.9 degrees C | 4.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Muscle Pain: Severe | 4.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Severe | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Joint Pain: Mild | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Fatigue: Moderate | 15.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention | Headache: Mild | 13.0 Percentage of participants |
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).
Time frame: 1 month after study intervention
Population: Evaluable immunogenicity population included eligible participants who received study intervention as randomized, had at least 1 valid assay result within 27 to 49 days after administration, and had no major protocol deviations. Participants from each candidate and candidate control group were included as per the protocol specified objective. Number of Participants Analyzed= participants in evaluable immunogenicity population \& had valid result 1 month after study intervention.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Candidate-1 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 231 Titer |
| Candidate-2 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 428 Titer |
| Candidate-3 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 350 Titer |
| Candidate-4 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 354 Titer |
| Candidate-5 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 324 Titer |
| Candidate-6 | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 536 Titer |
| Candidate - Control | Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group | 168 Titer |