Pneumococcal DiseasePhase 4NCT05329259
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
A Phase 4 study testing 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 5 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesIndia
- Study dates
- 6 Oct 2022to 30 Nov 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, 305001
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, 560060
Aakash Healthcare Private Limited
Delhi, 110075
Calcutta School of Tropical Medicine
Kolkata, West Bengal, 700073
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
About this study
Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA
- 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.
- Conditions
- Pneumococcal Disease
- Being tested
- 13-valent pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent pneumococcal conjugate vaccineBiological
One dose of 13vPnC (0.5mL) will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine (13vPnC) Receives: Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 1 Month After Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start6 Oct 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329259
- Sponsor's protocol ID
- B1851214
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2022
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA
- ClinicalTrials.gov ID
- NCT05329259
- Acronym / sponsor ID
- B1851214
- Conditions
- Pneumococcal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | Biological: 13-valent pneumococcal conjugate vaccinePneumococcal conjugate vaccine (13vPnC) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13-valent pneumococcal conjugate vaccineOne dose of 13vPnC (0.5mL) will be administered intramuscularly. | Biological | 13-valent pneumococcal conjugate vaccine |
Primary outcome
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination (time frame: Within 7 Days After Vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.