Trial Outcomes & Findings for A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India (NCT NCT05329259)
NCT ID: NCT05329259
Last Updated: 2024-04-26
Results Overview
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.
COMPLETED
PHASE4
200 participants
Within 7 Days After Vaccination
2024-04-26
Participant Flow
This study was conducted in India. Participants took part in the study for approximately 1 month.
A total of 200 participants were enrolled and vaccinated, all participants completed the 1-month follow-up after vaccination.
Participant milestones
| Measure |
13vPnC
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Vaccination Period
STARTED
|
200
|
|
Vaccination Period
COMPLETED
|
200
|
|
Vaccination Period
NOT COMPLETED
|
0
|
|
1-Month Follow-Up Period
STARTED
|
200
|
|
1-Month Follow-Up Period
COMPLETED
|
200
|
|
1-Month Follow-Up Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Baseline characteristics by cohort
| Measure |
13vPnC
n=200 Participants
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Age, Continuous
|
29.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race_Asian
|
200 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity_Non-Hispanic/Non-Latino
|
200 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days After VaccinationPopulation: The safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
13vPnC
n=200 Participants
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
Redness
|
1.5 Percentage
Interval 0.3 to 4.3
|
|
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
Swelling
|
6.5 Percentage
Interval 3.5 to 10.9
|
|
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
Pain at Injection Site
|
63.0 Percentage
Interval 55.9 to 69.7
|
PRIMARY outcome
Timeframe: Within 7 Days After VaccinationPopulation: The safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
13vPnC
n=200 Participants
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
Fever
|
3.0 Percentage
Interval 1.1 to 6.4
|
|
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
Fatigue
|
25.0 Percentage
Interval 19.2 to 31.6
|
|
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
Headache
|
23.0 Percentage
Interval 17.4 to 29.5
|
|
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
Joint Pain
|
7.5 Percentage
Interval 4.3 to 12.1
|
|
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
Muscle Pain
|
32.0 Percentage
Interval 25.6 to 38.9
|
PRIMARY outcome
Timeframe: Within 1 Month After VaccinationPopulation: The safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
13vPnC
n=200 Participants
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
|
0.5 Percentage
Interval 0.0 to 2.8
|
PRIMARY outcome
Timeframe: Within 1 Month After VaccinationPopulation: The safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
13vPnC
n=200 Participants
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination
|
0 Percentage
Interval 0.0 to 1.8
|
Adverse Events
13vPnC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
13vPnC
n=200 participants at risk
Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1.
|
|---|---|
|
Infections and infestations
Varicella
|
0.50%
1/200 • Number of events 1 • Within 1 month after vaccination.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received study intervention and had safety data assessed after vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER