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Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05489328
Enrollment
394
Registered
2022-08-05
Start date
2022-08-15
Completion date
2022-10-07
Last updated
2024-04-18

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

Conditions

Pneumococcal Disease

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

OTHERCandidate-1

Biological

OTHERCandidate-2

Biological

OTHERCandidate-3

Biological

OTHERCandidate-4

Biological

OTHERCandidate-5

Biological

OTHERCandidate-6

Biological

OTHERCandidate Control

Biological

BIOLOGICAL13vPnC

13-valent pneumococcal conjugate vaccine

BIOLOGICALPCV15

15-valent pneumococcal conjugate vaccine

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionWithin 7 days after study interventionLocal 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 InterventionWithin 7 days after study interventionSystemic 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 InterventionWithin 1 month after study interventionAn 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 InterventionWithin 1 month after study interventionAn 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

MeasureTime frameDescription
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group1 month after study interventionGMTs 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

ArmCount
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
Total391

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyLost to Follow-up001020010
Overall StudyOther000000011
Overall StudyWithdrawal by Subject000000110

Baseline characteristics

CharacteristicCandidate-1Candidate-2Candidate-3Candidate-4Candidate-5Candidate-6Candidate - ControlPCV1513vPnCTotal
Age, Continuous35.9 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 Participants15 Participants12 Participants12 Participants12 Participants20 Participants14 Participants14 Participants16 Participants128 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants27 Participants27 Participants32 Participants33 Participants26 Participants31 Participants29 Participants30 Participants262 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants3 Participants3 Participants1 Participants4 Participants1 Participants4 Participants22 Participants
Race (NIH/OMB)
Black or African American
14 Participants4 Participants8 Participants8 Participants5 Participants6 Participants9 Participants7 Participants8 Participants69 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants1 Participants6 Participants
Race (NIH/OMB)
White
25 Participants35 Participants26 Participants32 Participants36 Participants37 Participants30 Participants33 Participants32 Participants286 Participants
Sex: Female, Male
Female
30 Participants26 Participants27 Participants24 Participants26 Participants25 Participants27 Participants19 Participants23 Participants227 Participants
Sex: Female, Male
Male
11 Participants16 Participants12 Participants20 Participants19 Participants21 Participants18 Participants24 Participants23 Participants164 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 420 / 390 / 440 / 450 / 460 / 450 / 430 / 46
other
Total, other adverse events
25 / 4127 / 4221 / 3928 / 4430 / 4530 / 4622 / 4532 / 4337 / 46
serious
Total, serious adverse events
0 / 410 / 420 / 390 / 441 / 450 / 460 / 450 / 430 / 46

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)
Candidate-1Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention2.4 Percentage of participants
Candidate-2Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention4.8 Percentage of participants
Candidate-3Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention5.1 Percentage of participants
Candidate-4Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate-5Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention8.9 Percentage of participants
Candidate-6Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention4.3 Percentage of participants
Candidate - ControlPercentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
PCV15Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention2.3 Percentage of participants
13vPnCPercentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention2.2 Percentage of participants
Primary

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.

ArmMeasureGroupValue (NUMBER)
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild12.2 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild0.0 Percentage of participants
Candidate-1Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate2.4 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate4.8 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate2.4 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-2Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild26.2 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild20.5 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe2.6 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate0.0 Percentage of participants
Candidate-3Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild0.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild2.3 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate0.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate2.3 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild0.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild25.0 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate2.3 Percentage of participants
Candidate-4Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate2.2 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild2.2 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate2.2 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild2.2 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild37.8 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate6.7 Percentage of participants
Candidate-5Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild4.3 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild6.5 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate17.4 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate0.0 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild23.9 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe2.2 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate2.2 Percentage of participants
Candidate-6Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild11.1 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate2.2 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild4.7 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate4.7 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate30.2 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate4.7 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe0.0 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild4.7 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild37.2 Percentage of participants
PCV15Percentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Moderate0.0 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Severe0.0 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Severe0.0 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Mild54.3 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Moderate2.2 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Moderate6.5 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionRedness: Mild0.0 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionPain At Injection Site: Severe2.2 Percentage of participants
13vPnCPercentage of Participants With Local Reactions Within 7 Days After Administration of Study InterventionSwelling: Mild8.7 Percentage of participants
Primary

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.

ArmMeasureValue (NUMBER)
Candidate-1Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate-2Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate-3Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate-4Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate-5Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention2.2 Percentage of participants
Candidate-6Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
PCV15Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
13vPnCPercentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention0.0 Percentage of participants
Primary

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.

ArmMeasureGroupValue (NUMBER)
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild17.1 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C2.4 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate14.6 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild34.1 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate7.3 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe2.4 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild12.2 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild2.4 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate0.0 Percentage of participants
Candidate-1Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate14.3 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild9.5 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C0.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate11.9 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild19.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe2.4 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild7.1 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C2.4 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild23.8 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate4.8 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C0.0 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe2.4 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate26.2 Percentage of participants
Candidate-2Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate12.8 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild5.1 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild12.8 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate12.8 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild20.5 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild25.6 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
Candidate-3Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C2.6 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate9.1 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate9.1 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild13.6 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild2.3 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate25.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe4.5 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild18.2 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate9.1 Percentage of participants
Candidate-4Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild13.6 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate31.1 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild6.7 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C4.4 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild13.3 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild11.1 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C2.2 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate4.4 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild8.9 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate20.0 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe4.4 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate6.7 Percentage of participants
Candidate-5Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe2.2 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate6.5 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild21.7 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate19.6 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe4.3 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild17.4 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate6.5 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe2.2 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild13.0 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate13.0 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe2.2 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe4.3 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild10.9 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C4.3 Percentage of participants
Candidate-6Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild2.2 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild4.4 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate11.1 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate2.2 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate6.7 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate0.0 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild15.6 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe2.2 Percentage of participants
Candidate - ControlPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild22.2 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe0.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild11.6 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild14.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate18.6 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe2.3 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe0.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate30.2 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate9.3 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild11.6 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild20.9 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C0.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C2.3 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe7.0 Percentage of participants
PCV15Percentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate14.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Moderate13.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >40.0 degrees C0.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Severe2.2 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Moderate13.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Moderate10.9 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.9 degrees C to 40.0 degrees C0.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Severe8.7 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Mild17.4 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >/=38.0 degrees C to 38.4 degrees C2.2 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Mild21.7 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFever: >38.4 degrees C to 38.9 degrees C4.3 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionMuscle Pain: Severe4.3 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Severe0.0 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionJoint Pain: Mild2.2 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionFatigue: Moderate15.2 Percentage of participants
13vPnCPercentage of Participants With Systemic Events Within 7 Days After Administration of Study InterventionHeadache: Mild13.0 Percentage of participants
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)
Candidate-1Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group231 Titer
Candidate-2Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group428 Titer
Candidate-3Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group350 Titer
Candidate-4Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group354 Titer
Candidate-5Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group324 Titer
Candidate-6Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group536 Titer
Candidate - ControlSerotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group168 Titer

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