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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine (13vPnC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | One dose of 13vPnC (0.5mL) will be administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 Days After Vaccination |
| 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. | Within 7 Days After Vaccination |
| 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. | Within 1 Month After Vaccination |
| 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. | Within 1 Month After Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nirmal Hospital Pvt Ltd. | Surat | Gujarat | 395002 | India | ||
| BGS Global Institute of Medical Sciences (BGSGIMS) |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 200 participants were enrolled and vaccinated, all participants completed the 1-month follow-up after vaccination.
This study was conducted in India. Participants took part in the study for approximately 1 month.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination Period |
| |||||||||||||
| 1-Month Follow-Up Period |
|
All participants who received any study intervention and had safety data assessed after vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage | Within 7 Days After Vaccination |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC | Participants received 1 intramuscular dose of 13-valent pneumococcal conjugate vaccine (13vPnC) on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Varicella | Infections and infestations | MeDRA v25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2021 | Nov 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2022 | Nov 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Bangalore |
| Karnataka |
| 560060 |
| India |
| Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | 305001 | India |
| Calcutta School of Tropical Medicine | Kolkata | West Bengal | 700073 | India |
| Aakash Healthcare Private Limited | Delhi | 110075 | India |
| Years |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | The safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage | Within 7 Days After Vaccination |
|
|
|
| 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. | The safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage | Within 1 Month After Vaccination |
|
|
|
| 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. | The safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage | Within 1 Month After Vaccination |
|
|
|
| 0 |
| 200 |
| 0 |
| 200 |
| 1 |
| 200 |
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.
| D007239 | Infections |
| Title | Measurements |
|---|---|
|
| Joint Pain |
|
| Muscle Pain |
|