NCT05875727

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

Completed Phase 3 Results posted Last updated 24 October 2024

What this trial tests

Phase 3 trial testing 20-valent pneumococcal conjugate vaccine in Pneumococcal Disease in 405 participants. Completed in 2 October 2023.

Timeline

16 August 2023

Primary endpoint
2 October 2023

2 October 2023

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	405
Start date	16 August 2023
Primary completion	2 October 2023
Estimated completion	2 October 2023
Sites	8 locations across India

Drugs / interventions tested

• 20-valent pneumococcal conjugate vaccine (20-valent-pneumococcal-conjugate-vaccine) — full drug profile →

Conditions studied

• Pneumococcal Disease — all drugs for Pneumococcal Disease →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Pneumococcal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Redness: Any

Group	Value	95% CI
Cohort 1: 18 to 49 Years	1.0	0.1 – 3.6
Cohort 2: >= 50 Years	1.0	0.1 – 3.6

Redness: Mild

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.0	0.0 – 1.8
Cohort 2: >= 50 Years	0.5	0.0 – 2.8

Redness: Moderate

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.5	0.0 – 2.8
Cohort 2: >= 50 Years	0.5	0.0 – 2.8

Redness: Severe

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.5	0.0 – 2.8
Cohort 2: >= 50 Years	0.0	0.0 – 1.8

Swelling: Any

Group	Value	95% CI
Cohort 1: 18 to 49 Years	1.5	0.3 – 4.3
Cohort 2: >= 50 Years	1.5	0.3 – 4.3

Swelling: Mild

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.5	0.0 – 2.8
Cohort 2: >= 50 Years	0.5	0.0 – 2.8

Swelling: Moderate

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.5	0.0 – 2.8
Cohort 2: >= 50 Years	1.0	0.1 – 3.6

Swelling: Severe

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0.5	0.0 – 2.8
Cohort 2: >= 50 Years	0.0	0.0 – 1.8

Percentage of Participants With Systemic Events Within 7 Days After Vaccination Primary · 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.

Fever: >= 38.0 degree C

Group	Value	95% CI
Cohort 1: 18 to 49 Years	3.0	1.1 – 6.4
Cohort 2: >= 50 Years	1.5	0.3 – 4.3

Fever: >=38.0 to 38.4 degree C

Group	Value	95% CI
Cohort 1: 18 to 49 Years	1.5	0.3 – 4.3
Cohort 2: >= 50 Years	0.5	0.0 – 2.8

Fever: >38.4 to 38.9 degree C

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0	0.0 – 1.8
Cohort 2: >= 50 Years	1.0	0.1 – 3.6

Fever: >38.9 to 40.0 degree C

Group	Value	95% CI
Cohort 1: 18 to 49 Years	1.5	0.3 – 4.3
Cohort 2: >= 50 Years	0	0.0 – 1.8

Fever: >40.0 degree C

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0	0.0 – 1.8
Cohort 2: >= 50 Years	0	0.0 – 1.8

Fatigue: Any

Group	Value	95% CI
Cohort 1: 18 to 49 Years	12.0	7.8 – 17.3
Cohort 2: >= 50 Years	12.0	7.8 – 17.3

Fatigue: Mild

Group	Value	95% CI
Cohort 1: 18 to 49 Years	7.5	4.3 – 12.1
Cohort 2: >= 50 Years	8.5	5.0 – 13.3

Fatigue: Moderate

Group	Value	95% CI
Cohort 1: 18 to 49 Years	4.0	1.7 – 7.7
Cohort 2: >= 50 Years	3.0	1.1 – 6.4

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

Group	Value	95% CI
Cohort 1: 18 to 49 Years	1.5	0.3 – 4.3
Cohort 2: >= 50 Years	3.0	1.1 – 6.4

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

Group	Value	95% CI
Cohort 1: 18 to 49 Years	0
Cohort 2: >= 50 Years	0

Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination Secondary · 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.

Serotype 1

Group	Value	95% CI
Cohort 1: 18 to 49 Years	24.3	17.2 – 34.3
Cohort 2: >= 50 Years	17.1	10.9 – 26.9

Serotype 3

Group	Value	95% CI
Cohort 1: 18 to 49 Years	8.9	5.7 – 13.8
Cohort 2: >= 50 Years	8.8	5.6 – 13.8

Serotype 4

Group	Value	95% CI
Cohort 1: 18 to 49 Years	15.2	7.7 – 29.8
Cohort 2: >= 50 Years	42.6	22.0 – 82.6

Serotype 5

Group	Value	95% CI
Cohort 1: 18 to 49 Years	14.9	8.6 – 25.8
Cohort 2: >= 50 Years	24.3	13.5 – 43.7

Serotype 6A

Group	Value	95% CI
Cohort 1: 18 to 49 Years	29.8	16.3 – 54.5
Cohort 2: >= 50 Years	30.9	17.5 – 54.7

Serotype 6B

Group	Value	95% CI
Cohort 1: 18 to 49 Years	8.6	5.0 – 15.0
Cohort 2: >= 50 Years	11.6	6.6 – 20.5

Serotype 7F

Group	Value	95% CI
Cohort 1: 18 to 49 Years	16.0	9.2 – 27.9
Cohort 2: >= 50 Years	24.1	15.6 – 37.4

Serotype 9V

Group	Value	95% CI
Cohort 1: 18 to 49 Years	4.8	3.2 – 7.1
Cohort 2: >= 50 Years	9.5	5.7 – 15.8

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

20vPnC

Serious: 0/400 (0%)

Deaths: 0/400

Other adverse events (7 terms — click to expand)

Reaction	System	20vPnC
Injection site pain (PAIN)	General disorders	—
Fatigue (FATIGUE)	General disorders	—
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	—
Headache (HEADACHE)	Nervous system disorders	—
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	—
Pyrexia (FEVER)	General disorders	—
Injection site swelling (SWELLING)	General disorders	—

Data from ClinicalTrials.gov NCT05875727 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Giriappa B, Choraria N, Ponce P, Drozd J, et al · · 2026 · cited 1× · PMID 41504209 · DOI 10.1080/21645515.2025.2605847