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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine (20vPnC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Biological | One dose of 20vPnC will be administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
- Generally healthy participants ≥18 years of age at the time of consent.
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) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41504209 | Derived | 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. |
| 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 405 participants signed the informed consent form. Two participants were screen failures and 3 were not assigned to receive study treatment and 400 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 18 to 49 Years | Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 milliliter (mL) of 20-valent pneumococcal conjugate vaccine (20vPnC) vaccine, intramuscularly (IM) on Day 1 (Visit 1). |
| FG001 | Cohort 2: >=50 Years | Pneumococcal vaccine naive participants aged more than or equal to (>=)50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all participants who received any study intervention and had safety data assessed after vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 18 to 49 Years | Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). |
| BG001 | Cohort 2: >= 50 Years |
| 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 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. | Safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 7 after vaccination |
|
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
As all participants received 20vPnC the AEs section was reported together.
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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 | 20vPnC | Pneumococcal vaccine naive participants aged 18 to 49 years and >=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (FATIGUE) | General disorders | MedDRA v26.1 | 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 | Dec 22, 2022 | Sep 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Sep 16, 2024 | 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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Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
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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. |
| From vaccination on Day 1 up to 1 Month after vaccination |
| From before vaccination to 1 Month after vaccination |
| Bangalore |
| Karnataka |
| 560060 |
| India |
| RajaRajeswari Medical College and Hospital | Bangalore | Karnataka | 560074 | India |
| RajaRajeswari Medical College and Hospital | Bengaluru | Karnataka | 560074 | India |
| Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre | Pune | Maharashtra | 411043 | India |
| Aakash Healthcare Private Limited | New Delhi | National Capital Territory of Delhi | 110075 | India |
| Jawahar Lal Nehru Hospital | Ajmer | Rajasthan | 305001 | India |
| Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | 305001 | India |
Pneumococcal vaccine naive participants aged >=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). |
| OG001 | Cohort 2: >= 50 Years | Pneumococcal vaccine naive participants aged >=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1). |
|
|
| Primary | 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. | Safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 7 after vaccination |
|
|
|
| Primary | 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. | Safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From vaccination on Day 1 up to 1 Month after vaccination |
|
|
|
| Primary | 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. | Safety population included all participants who received any study intervention and had safety data assessed after vaccination. | Posted | Number | Percentage of participants | From vaccination on Day 1 up to 1 Month after vaccination |
|
|
|
| Secondary | 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. | Evaluable immunogenicity population evaluated. Number of participants analyzed= Number of participants in evaluable immunogenicity population. Number Analyzed = Number of evaluable participants with valid OPA titers for the specified serotype both before and after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From before vaccination to 1 Month after vaccination |
|
|
|
| 0 |
| 400 |
| 0 |
| 400 |
| 171 |
| 400 |
| Injection site pain (PAIN) | General disorders | MedDRA v26.1 | Systematic Assessment |
|
| Injection site swelling (SWELLING) | General disorders | MedDRA v26.1 | Systematic Assessment |
|
| Pyrexia (FEVER) | General disorders | MedDRA v26.1 | Systematic Assessment |
|
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
|
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
|
| Headache (HEADACHE) | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
|
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 |
| Fever: >38.4 to 38.9 degree C |
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| Fever: >38.9 to 40.0 degree C |
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| Fever: >40.0 degree C |
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| Fatigue: Any |
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| Fatigue: Mild |
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| Fatigue: Moderate |
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| Fatigue: Severe |
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| Headache: Any |
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| Headache: Mild |
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| Headache: Moderate |
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| Headache: Severe |
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| Joint pain: Any |
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| Joint pain: Mild |
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| Joint pain: Moderate |
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| Joint pain: Severe |
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| Muscle pain: Any |
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| Muscle pain: Mild |
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| Muscle pain: Moderate |
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| Muscle pain: Severe |
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| Serotype 3 |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 23F |
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| Serotype 8 |
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| Serotype 10A |
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| Serotype 11A |
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| Serotype 12F |
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| Serotype 15B |
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| Serotype 22F |
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| Serotype 33F |
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