Vaccine Effectiveness of 20-VALENT Pneumococcal Conjugate Vaccine Against Vaccine-Type Cap Using a Test-Negative Design

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

11 Apr 2024 → ongoing

Decision date (initial)

2024-03-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2023-507293-40-00

ClinicalTrials.gov

NCT05452941

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine the effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C.

Secondary objectives 7

1. To determine the effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C.
2. To determine European/Israeli specific effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C
3. To determine the effectiveness of 20vPnC by various participant characteristics (e.g., age, sex, chronic medical conditions, immunocompromising conditions) among participants with RAD+CAP.
4. To determine the effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C in participants with prior influenza vaccination
5. To determine the effectiveness of 20vPnC against all RAD+CAP by prior vaccination history
6. To determine the effectiveness of 20vPnC against all RAD+CAP due to individual serotypes contained in 20vPnC.
7. To determine the effectiveness of 20vPnC against all RAD+CAP due to the 13 shared serotypes contained in 20vPnC and 13vPnC

Conditions and MedDRA coding

VACCINE-TYPE RADIOLOGICALLY-CONFIRMED COMMUNITY-ACQUIRED PNEUMONIA

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Commission, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female participants ≥65 years of age.
2. Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:  fever (oral temperature >38.0°C/100.4°F or tympanic temperature >38.5°C/101.2°F),  hypothermia (<35.5°C/95.9°F measured by a healthcare provider) chills or rigors,  pleuritic chest pain,  new or worsening cough,  sputum production,  dyspnea (shortness of breath),  tachypnea (respiratory rate >20/min),  malaise, or  abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
3. Has a radiographic finding that is consistent with pneumonia (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates [multi-lobar, lobar, or segmental] containing air bronchograms).
4. Capable of giving signed informed consent as described in Appendix 1 of the Protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion criteria 4

1. Any participant who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at the study site, another transferring hospital, or a combination of these).
2. Received any pneumococcal vaccine ≤30 days prior to enrollment.
3. Unable to provide urine specimen (e.g. anuric).
4. Previous enrollment in the study within the past 30 days.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. VE calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables.

Secondary endpoints 7

1. VE calculated as 1 minus the OR for 20vPnC vaccination among cases versus controls* multiplied by 100 adjusted for potentially confounding variables.
2. VE calculated as 1 minus the OR of 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables, using data from European/Israeli participants
3. Among participants with RAD+CAP: • VE by age group (i.e., 65–74 years, 75–84 years, and ≥85 years) • VE by sex (i.e., male vs female) • VE by ACIP-defined risk group and by age group
4. VE by prior influenza vaccination in past 12 months (ie, vaccinated vs. non-vaccinated); VE by co-administration of influenza vaccination
5. VE against 13vPnC serotypes, the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C and 20vPnC serotypes by previous vaccination with 13vPnC
6. VE against individual serotypes
7. VE against the 13 shared serotypes contained in 20vPnC and 13vPnC

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 6

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications