Pneumococcal Disease
Conditions
Brief summary
* The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India. * This study is seeking participants who are generally healthy adults ≥18 and \<50 years of age, with no prior history of pneumococcal vaccination. * Participants will take part in the study for approximately one month which includes two visits to the study clinic. * Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
One dose of 13vPnC (0.5mL) will be administered intramuscularly.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy participants between the ages of ≥18 and \<50 years at the time of consent. * Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid-containing vaccine. * Congenital, functional, or surgical asplenia. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination | Within 7 Days After Vaccination | From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, local reactions including redness, swelling, and pain at the injection site were assessed and recorded. |
| Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Within 7 Days After Vaccination | From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, systemic events including fever, headache, fatigue, muscle pain, and joint pain were assessed and recorded. Fever was defined as temperature ≥38.0 °C. |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 Month After Vaccination | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were not collected as AEs. |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination | Within 1 Month After Vaccination | An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event. |
Countries
India
Participant flow
Recruitment details
This study was conducted in India. Participants took part in the study for approximately 1 month.
Pre-assignment details
A total of 200 participants were enrolled and vaccinated, all participants completed the 1-month follow-up after vaccination.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age, Continuous | 29.0 Years |
| Race/Ethnicity, Customized Ethnicity_Non-Hispanic/Non-Latino | 200 Participants |
| Race/Ethnicity, Customized Race_Asian | 200 Participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 1 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were not collected as AEs.
Time frame: Within 1 Month After Vaccination
Population: The safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 0.5 Percentage |
Primary
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, local reactions including redness, swelling, and pain at the injection site were assessed and recorded.
Time frame: Within 7 Days After Vaccination
Population: The safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination | Redness | 1.5 Percentage |
| 13vPnC | Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination | Swelling | 6.5 Percentage |
| 13vPnC | Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination | Pain at Injection Site | 63.0 Percentage |
Primary
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, systemic events including fever, headache, fatigue, muscle pain, and joint pain were assessed and recorded. Fever was defined as temperature ≥38.0 °C.
Time frame: Within 7 Days After Vaccination
Population: The safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Fever | 3.0 Percentage |
| 13vPnC | Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Fatigue | 25.0 Percentage |
| 13vPnC | Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Headache | 23.0 Percentage |
| 13vPnC | Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Joint Pain | 7.5 Percentage |
| 13vPnC | Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination | Muscle Pain | 32.0 Percentage |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination
An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Time frame: Within 1 Month After Vaccination
Population: The safety population included all participants who received any study intervention and had safety data assessed after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC | Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination | 0 Percentage |