Pneumococcal DiseasePhase 3NCT05875727

A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 8 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: are generally healthy adults of 18 years or older. have not received pneumococcal vaccine. The study will have 2 groups based on age. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: 20-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: 405 participants
Where: 8 sitesIndia
Study dates: 16 Aug 2023to 2 Oct 2023
Phase: Phase 3
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Generally healthy participants ≥18 years of age at the time of consent.

Who cannot join

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine.
Known or suspected immune deficiency or suppression.
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

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

India8 sites

Jawahar Lal Nehru Hospital
Ajmer, Rajasthan, 305001
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, 305001
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, 560060
RajaRajeswari Medical College and Hospital
Bangalore, Karnataka, 560074
RajaRajeswari Medical College and Hospital
Bengaluru, Karnataka, 560074
Aakash Healthcare Private Limited
New Delhi, National Capital Territory of Delhi, 110075
Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre
Pune, Maharashtra, 411043
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002

Other trials in India

About this study

Official title: A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India.

This study is seeking participants who:

are generally healthy adults of 18 years or older.
have not received pneumococcal vaccine.

The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older.

Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.

The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Conditions: Pneumococcal Disease
Being tested: 20-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.

20-valent pneumococcal conjugate vaccineBiological
One dose of 20vPnC will be administered intramuscularly.

Study groups in NCT05875727
Study group	Role	What they receive
20-valent pneumococcal conjugate vaccine	Experimental	Pneumococcal conjugate vaccine (20vPnC) Receives: Biological: 20-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 Local Reactions Within 7 Days After Vaccination
Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0 cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (>=)38.0 degree Celsius (C) and was classified as >=38.0 degree C, >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Measured: Day 1 to Day 7 after vaccination
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Measured: From vaccination on Day 1 up to 1 Month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.
Measured: From vaccination on Day 1 up to 1 Month after vaccination

Secondary outcomes (1)

Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
GMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician.
Measured: From before vaccination to 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.

16 Aug 20232 Oct 2023

First posted25 May 2023
Study start16 Aug 2023
Primary completion2 Oct 2023
Study completion2 Oct 2023

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
Masking: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05875727
Sponsor's protocol ID: B7471010
Status last verified: Oct 2024
First submitted: 16 May 2023
Last updated: 24 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
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.

Publications

Giriappa B, Choraria N, Ponce P, Drozd J, Su X, Lei L, Portka M, Pai S, Anderson A, Bickham K, Watson W, McElwee K. Immunogenicity and safety of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=18 years of age in India: A phase 3 single-arm trial. Hum Vaccin Immunother. 2026 Dec;22(1):2605847. doi: 10.1080/21645515.2025.2605847. Epub 2026 Jan 7.
PubMed 41504209

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA
ClinicalTrials.gov ID: NCT05875727
Acronym / sponsor ID: B7471010
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 16 Aug 2023 (actual)
Primary completion: 2 Oct 2023 (actual)
Study completion: 2 Oct 2023 (actual)
First posted: 25 May 2023 (actual)
Results: Posted 24 Oct 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 learn about the safety and immune response of 20vPnC in adults in India.

This study is seeking participants who:

are generally healthy adults of 18 years or older.
have not received pneumococcal vaccine.

The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older.

The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.

Arm	Type	Receives
20-valent pneumococcal conjugate vaccine	Experimental	Biological: 20-valent pneumococcal conjugate vaccinePneumococcal conjugate vaccine (20vPnC)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Generally healthy participants ≥18 years of age at the time of consent.

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 20vPnC, or to any other diphtheria toxoid-containing vaccine.
Known or suspected immune deficiency or suppression.
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
20-valent pneumococcal conjugate vaccineOne dose of 20vPnC will be administered intramuscularly.	Biological	20-valent pneumococcal conjugate vaccine

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Time frame: Day 1 to Day 7 after vaccination
Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0 cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Time frame: Day 1 to Day 7 after vaccination
Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (>=)38.0 degree Celsius (C) and was classified as >=38.0 degree C, >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
Time frame: From vaccination on Day 1 up to 1 Month after vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
Time frame: From vaccination on Day 1 up to 1 Month after vaccination
An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.

1 secondary outcome

Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Time frame: From before vaccination to 1 Month after vaccination

Results and safety

Results posted to the registry on 24 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: 18 to 49 Years	200	200
Cohort 2: >=50 Years	200	200

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination

Time frame: Day 1 to Day 7 after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Cohort 1: 18 to 49 Years n = 200	Cohort 2: >= 50 Years n = 200
Redness: Any	1.0 (0.1 to 3.6)	1.0 (0.1 to 3.6)
Redness: Mild	0.0 (0.0 to 1.8)	0.5 (0.0 to 2.8)
Redness: Moderate	0.5 (0.0 to 2.8)	0.5 (0.0 to 2.8)
Redness: Severe	0.5 (0.0 to 2.8)	0.0 (0.0 to 1.8)
Swelling: Any	1.5 (0.3 to 4.3)	1.5 (0.3 to 4.3)
Swelling: Mild	0.5 (0.0 to 2.8)	0.5 (0.0 to 2.8)
Swelling: Moderate	0.5 (0.0 to 2.8)	1.0 (0.1 to 3.6)
Swelling: Severe	0.5 (0.0 to 2.8)	0.0 (0.0 to 1.8)

Population analysed: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Time frame: Day 1 to Day 7 after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Cohort 1: 18 to 49 Years n = 200	Cohort 2: >= 50 Years n = 200
Fever: >= 38.0 degree C	3.0 (1.1 to 6.4)	1.5 (0.3 to 4.3)
Fever: >=38.0 to 38.4 degree C	1.5 (0.3 to 4.3)	0.5 (0.0 to 2.8)
Fever: >38.4 to 38.9 degree C	0 (0.0 to 1.8)	1.0 (0.1 to 3.6)
Fever: >38.9 to 40.0 degree C	1.5 (0.3 to 4.3)	0 (0.0 to 1.8)
Fever: >40.0 degree C	0 (0.0 to 1.8)	0 (0.0 to 1.8)
Fatigue: Any	12.0 (7.8 to 17.3)	12.0 (7.8 to 17.3)
Fatigue: Mild	7.5 (4.3 to 12.1)	8.5 (5.0 to 13.3)
Fatigue: Moderate	4.0 (1.7 to 7.7)	3.0 (1.1 to 6.4)

Population analysed: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

Primary outcome: Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination

Time frame: From vaccination on Day 1 up to 1 Month after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Cohort 1: 18 to 49 Years n = 200	Cohort 2: >= 50 Years n = 200
Value	1.5 (0.3 to 4.3)	3.0 (1.1 to 6.4)

Population analysed: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

Primary outcome: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination

Time frame: From vaccination on Day 1 up to 1 Month after vaccination. Number. Unit: Percentage of participants

Measure	Cohort 1: 18 to 49 Years n = 200	Cohort 2: >= 50 Years n = 200
Value	0	0

Population analysed: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20vPnC	0 of 400 (0%)	171 of 400 (42.8%)	0 of 400

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41504209Giriappa B, Choraria N, Ponce P, Drozd J, Su X, Lei L, Portka M, Pai S, Anderson A, Bickham K, Watson W, McElwee K. Immunogenicity and safety of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=18 years of age in India: A phase 3 single-arm trial. Hum Vaccin Immunother. 2026 Dec;22(1):2605847. doi: 10.1080/21645515.2025.2605847. Epub 2026 Jan 7.
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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 8 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 1 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Oct 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 Local Reactions Within 7 Days After Vaccination (time frame: Day 1 to Day 7 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?

On the ClinicalTrials.gov record for NCT05875727, which also lists 1 linked publication.

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 24 Oct 2024.