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Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Primary Purpose

Infections, Meningococcal

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)

About this trial

This is an interventional prevention trial for Infections, Meningococcal focused on measuring Meningococcal disease, Booster vaccination, Meningitis, Antibody persistence

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals of 15 through 55 years of age on the day of informed consent or assent.
Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
Individuals who can comply with study procedures including follow-up.
Males Or Females of non-childbearing potential Or
- Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.

Exclusion Criteria:

Each subject must not have:

History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
Received immunoglobulins or any blood products within 180 days prior to informed consent.
Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
Study personnel as an immediate family or household member.
Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Menveo-Menveo Group

Menactra-Menveo Group

Naive Group

Arm Description

Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.

Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.

Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.

Outcomes

Primary Outcome Measures

Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.

Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives

Secondary Outcome Measures

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Number of Subjects Reporting Solicited Local and Systemic AEs

Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)

Number of Subjects Reporting Other Indicators of Reactogenicity

Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)

Number of Subjects Reporting All Unsolicited AEs

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)

Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C

Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y

Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.

hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.

For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.

Within Group hSBA Geometric Mean Ratios (GMRs)

Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.

Full Information

NCT ID

NCT02986854

First Posted

December 6, 2016

Last Updated

November 14, 2019

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02986854

Brief Title

Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Official Title

A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 8, 2016 (Actual)

Primary Completion Date

July 17, 2017 (Actual)

Study Completion Date

December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects

Detailed Description

This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial. Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio. Blood draws at Day 1, Day 4 and Day 29 Blood draws at Day 1, Day 6 and Day 29

6. Conditions and Keywords

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

Infections, Meningococcal

Keywords

Meningococcal disease, Booster vaccination, Meningitis, Antibody persistence

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

704 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menveo-Menveo Group

Arm Type

Experimental

Arm Description

Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.

Arm Title

Menactra-Menveo Group

Arm Type

Experimental

Arm Description

Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.

Arm Title

Naive Group

Arm Type

Active Comparator

Arm Description

Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.

Intervention Type

Biological

Intervention Name(s)

Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)

Intervention Description

One intramuscular injection of MenACWY at Day 1.

Primary Outcome Measure Information:

Title

Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.

Description

Time Frame

At Day 29

Secondary Outcome Measure Information:

Title

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

Description

Time Frame

Within 30 minutes after vaccination

Title

Number of Subjects Reporting Solicited Local and Systemic AEs

Description

Time Frame

From Day 1 (6 hours) through Day 7 after vaccination

Title

Number of Subjects Reporting Other Indicators of Reactogenicity

Description

Time Frame

From Day 1 (6 hours) through Day 7 after vaccination

Title

Number of Subjects Reporting All Unsolicited AEs

Description

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Time Frame

From Day 1 through Day 29 after vaccination

Title

Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)

Description

Time Frame

From Day 1 through Day 181 (entire study period)

Title

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Time Frame

At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

Title

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination) , day 4, day 6 and day 29

Title

Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination), day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination), day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination), day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C

Description

Time Frame

At day 1(pre-vaccination) , day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination), day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y

Description

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Time Frame

At day 1(pre-vaccination) , day 4, day 6 and day 29

Title

Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y

Description

Time Frame

At Day 4 and Day 6

Title

hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.

Description

For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.

Time Frame

At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

Title

Within Group hSBA Geometric Mean Ratios (GMRs)

Description

Time Frame

At Day 4, Day 6, Day 29 compared to Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals of 15 through 55 years of age on the day of informed consent or assent. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent. Individuals who can comply with study procedures including follow-up. Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination. Exclusion Criteria: Each subject must not have: History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration. Current or previous, confirmed or suspected disease caused by N. meningitidis. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination. Progressive, unstable or uncontrolled clinical conditions. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws. Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination. Received immunoglobulins or any blood products within 180 days prior to informed consent. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw. Received an investigational or non-registered medicinal product within 30 days prior to study vaccination. Study personnel as an immediate family or household member. Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

GSK Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35802

Country

United States

Facility Name

GSK Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

GSK Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95864

Country

United States

Facility Name

GSK Investigational Site

City

San Jose

State/Province

California

ZIP/Postal Code

95119

Country

United States

Facility Name

GSK Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

GSK Investigational Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80128

Country

United States

Facility Name

GSK Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

GSK Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60604

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205-1138

Country

United States

Facility Name

GSK Investigational Site

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

GSK Investigational Site

City

Binghamton

State/Province

New York

ZIP/Postal Code

13901

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

Facility Name

GSK Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

GSK Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

GSK Investigational Site

City

San Angelo

State/Province

Texas

ZIP/Postal Code

76904

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

GSK Investigational Site

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

GSK Investigational Site

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

GSK Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20103

Citations:

PubMed Identifier

31495595

Citation

Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.

Results Reference

background

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=205352&attachmentIdentifier=4b9c0f0f-df12-453e-bed2-1e14b1b278a1&fileName=gsk-205352-clinical-study-report-redact.pdf&versionIdentifier=

Description

Full CSR posting on GSK

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Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Infections, Meningococcal

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial