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Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

Primary Purpose

Lyme Borreliosis

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

VLA15

Placebo

About this trial

This is an interventional prevention trial for Lyme Borreliosis focused on measuring VLA15, Lyme Borreliosis, Vaccine, Lyme disease, Borrelia

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subject is aged 5 to 65 years at the day of screening (Visit 0)
Subject is of good general health
Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions
- for subjects aged 18-65 years: written informed consent prior to any study related procedures
- for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:
- Main Study Phase: duration of entire study
- Booster Phase: until Month 23 (i.e. 5 months after booster dose)
Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
Subject is available for the duration of the study and can be contacted by telephone during study participation

Exclusion Criteria:

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
Subject received previous vaccination against LB;
Subject had a tick bite within 4 weeks prior to Day 1;
Subject has a medical history of or currently has a clinically relevant disease;
Subject has a medical history of or currently has a neuro-inflammatory or autoimmune disease;
Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
Subject has received an active or passive immunization within 4 weeks prior to Day 1;
Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
Subject had any malignancy in the past 5 years;
Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
Subject is in a dependent relationship;

Sites / Locations

New England Research Associates
Stamford Therapeutics Consortium
Chase Medical Research, LLC
Pediatric Associates of Conn. PC
Quest Diagnostics
Clinical Research Institute, Inc.
Foundation Pediatrics
Med Clinical Research Partners, LLC
Meridian Clinical Research LLC
Advantage Clinical Trials
Pfizer Vaccine Research and Development
Rochester Clinical Research, Inc.
Richmond Behavioral Associates
Velocity Clinical Research, Inc.
Allegheny Health and Wellness Pavilion
Liberty Family Practice
Lockman & Lubell Pediatric Associates
Hasbro Children's Hospital
Rhode Island Hospital
The Miriam Hospital
Velocity Clinical Research Providence
Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Part A+B - Group 1

Part A+B - Group 2

Part A+B - Group 3

Arm Description

Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15

Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15

Part A: Placebo at Month 0, 2 and 6 Part B: Placebo

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1

Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.

Secondary Outcome Measures

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose

Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Percentage of Participants With Serious Adverse Events (SAEs)

SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.

Percentage of Participants With Adverse Events of Special Interest (AESIs)

An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method.

Percentage of Participants With Unsolicited Adverse Events

An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.

Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group

Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.

Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208

Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.

Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase

GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).

Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase

SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.

Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase

GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase

SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase

Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a >= 4-fold rise in OspA IgG antibody titer from screening.

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

Full Information

NCT ID

NCT04801420

First Posted

March 8, 2021

Last Updated

May 10, 2023

Sponsor

Pfizer

Collaborators

Valneva Austria GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04801420

Brief Title

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

Official Title

SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

March 25, 2022 (Actual)

Study Completion Date

January 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Valneva Austria GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0-6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 19 months in Part A and additional 37 months for subjects enrolled in the Part B.

Detailed Description

VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B all eligible subjects will receive a booster injection with VLA15 or placebo at Month 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lyme Borreliosis

Keywords

VLA15, Lyme Borreliosis, Vaccine, Lyme disease, Borrelia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

625 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A+B - Group 1

Arm Type

Experimental

Arm Description

Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15

Arm Title

Part A+B - Group 2

Arm Type

Experimental

Arm Description

Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15

Arm Title

Part A+B - Group 3

Arm Type

Placebo Comparator

Arm Description

Part A: Placebo at Month 0, 2 and 6 Part B: Placebo

Intervention Type

Biological

Intervention Name(s)

VLA15

Intervention Description

a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

PBS (Phosphate Buffered Saline)

Primary Outcome Measure Information:

Title

Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1

Description

Time Frame

From Day 1 to Day 7 after vaccination 1 at Month 0

Title

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

Description

Time Frame

From Day 1 to Day 7 after vaccination 2 at Month 2

Title

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3

Description

Time Frame

From Day 1 to Day 7 after vaccination 3 at Month 6

Title

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

Description

Time Frame

From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively

Title

Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase

Description

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.

Time Frame

Day 208 (Month 7)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose

Description

Time Frame

Within 7 days after booster dose

Title

Percentage of Participants With Serious Adverse Events (SAEs)

Description

Time Frame

From Day 1 of vaccination up to Day 208 (Month 7)

Title

Percentage of Participants With Adverse Events of Special Interest (AESIs)

Description

Time Frame

From Day 1 of vaccination up to Day 208 (Month 7)

Title

Percentage of Participants With Unsolicited Adverse Events

Description

Time Frame

From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively

Title

Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group

Description

Time Frame

SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively

Title

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase

Description

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.

Time Frame

Baseline, Day 85, Day 180 and Day 194

Title

Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208

Description

Time Frame

Day 85, Day 180, Day 194 and Day 208

Title

Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase

Description

GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.

Time Frame

Baseline, Day 85 and 208

Title

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase

Description

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).

Time Frame

Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

Title

Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase

Description

Time Frame

Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

Title

Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase

Description

Time Frame

Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

Title

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase

Time Frame

Up to Month 54

Title

SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase

Description

Time Frame

Up to Month 54

Title

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase

Time Frame

Month 19

Title

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

Time Frame

Up to Month 54

Title

SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase

Description

Time Frame

Up to Month 54

Title

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

Time Frame

Up to Month 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is aged 5 to 65 years at the day of screening (Visit 0) Subject is of good general health Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions for subjects aged 18-65 years: written informed consent prior to any study related procedures for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures. If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines: Main Study Phase: duration of entire study Booster Phase: until Month 23 (i.e. 5 months after booster dose) Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures Subject is available for the duration of the study and can be contacted by telephone during study participation Exclusion Criteria: Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1; Subject received previous vaccination against LB; Subject had a tick bite within 4 weeks prior to Day 1; Subject has a medical history of or currently has a clinically relevant disease; Subject has a medical history of or currently has a neuro-inflammatory or autoimmune disease; Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1; Subject has received an active or passive immunization within 4 weeks prior to Day 1; Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1; Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1; Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine; Subject had any malignancy in the past 5 years; Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment; Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1; Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study; Subject is in a dependent relationship;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Principal Investigator

Facility Information:

Facility Name

New England Research Associates

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Stamford Therapeutics Consortium

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Chase Medical Research, LLC

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Pediatric Associates of Conn. PC

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Quest Diagnostics

City

Marlborough

State/Province

Massachusetts

ZIP/Postal Code

01752

Country

United States

Facility Name

Clinical Research Institute, Inc.

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Foundation Pediatrics

City

East Orange

State/Province

New Jersey

ZIP/Postal Code

07018

Country

United States

Facility Name

Med Clinical Research Partners, LLC

City

Irvington

State/Province

New Jersey

ZIP/Postal Code

07111

Country

United States

Facility Name

Meridian Clinical Research LLC

City

Binghamton

State/Province

New York

ZIP/Postal Code

13901

Country

United States

Facility Name

Advantage Clinical Trials

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

Facility Name

Pfizer Vaccine Research and Development

City

Pearl River

State/Province

New York

ZIP/Postal Code

10965

Country

United States

Facility Name

Rochester Clinical Research, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Richmond Behavioral Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Velocity Clinical Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Allegheny Health and Wellness Pavilion

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16506

Country

United States

Facility Name

Liberty Family Practice

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

Lockman & Lubell Pediatric Associates

City

Fort Washington

State/Province

Pennsylvania

ZIP/Postal Code

19034

Country

United States

Facility Name

Hasbro Children's Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

The Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Velocity Clinical Research Providence

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik

City

Berlin

ZIP/Postal Code

12247

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=VLA15-221

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

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