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A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Primary Purpose

Meningococcal Disease, Infections, Meningococcal

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MenABCWY+OMV vaccine

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Antibody persistence, Young Adults, Healthy Adolescents, MenABCWY vaccine, Booster response, MenABCWY+OMV

Eligibility Criteria

15 Years - 23 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1 (NCT01367158) study and who received no other meningococcal vaccines; Or A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102_02 (NCT01210885) study and have not previously received any meningococcal vaccine.
Individuals who / whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including blood draws and follow-up.
Males Or Females of non-childbearing potential Or Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination

Exclusion Criteria:

History of any meningococcal vaccine administration (study group C) or History of any meningococcal vaccine administration other than vaccination given in the parent V102_02 (NCT01210885) study (study groups A and B).
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
Abnormal function of the immune system resulting from:
a.Clinical conditions.
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Received immunoglobulins or any blood products within 90 days prior to enrollment.
Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines.
Study personnel as an immediate family or household member.
Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment.
Who have received systemic antibiotic treatment within 3 days prior to enrollment.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MenABCWY+OMV Group

MenACWY Group

Naive Group

Arm Description

Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1.

Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study.

Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study.

Outcomes

Primary Outcome Measures

Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

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

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8.

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

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

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Secondary Outcome Measures

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8.

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

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

GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

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

GMTs at Day 1, 31, 34, 38, 61 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who were not primed with any meningococcal vaccine (i.e., Naïve Group). This outcome measure reports data for only the Naïve Group as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 19 and 20 and are considered final in Company's judgement.

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Immunogenicity against N. meningitidis serogroup A, C, W and Y following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 8.

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Immunogenicity against N. meningitidis serogroup B test strains following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination

Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination.

Number of Subjects With Any Solicited Local Symptoms

Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site.

Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data

Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.

Number of Subjects With Unsolicited Adverse Events (AEs).

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination.

Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.

Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination.

Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.

The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination.

Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination.

Full Information

NCT ID

NCT02451514

First Posted

May 4, 2015

Last Updated

June 24, 2020

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02451514

Brief Title

A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Official Title

A Phase 2, Open-label, Controlled, Multi-center Extension Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 30, 2015 (Actual)

Primary Completion Date

November 14, 2015 (Actual)

Study Completion Date

December 10, 2015 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY

Detailed Description

Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio

6. Conditions and Keywords

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

Meningococcal Disease, Infections, Meningococcal

Keywords

Antibody persistence, Young Adults, Healthy Adolescents, MenABCWY vaccine, Booster response, MenABCWY+OMV

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MenABCWY+OMV Group

Arm Type

Experimental

Arm Description

Arm Title

MenACWY Group

Arm Type

Experimental

Arm Description

Arm Title

Naive Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

MenABCWY+OMV vaccine

Intervention Description

Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.

Primary Outcome Measure Information:

Title

Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

Time Frame

At Day 1 (4 years persistence)

Title

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Description

Time Frame

At Day 1 (4 years persistence)

Title

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Description

Time Frame

At Day 1 (4 years persistence)

Title

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

Description

Time Frame

At Day 1

Title

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains.

Description

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.

Time Frame

At Day 31

Title

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Description

Time Frame

At Day 31

Title

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Description

Time Frame

At Day 31

Title

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

Description

Time Frame

At Day 31

Title

Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

Time Frame

Day 31 versus Day 1

Secondary Outcome Measure Information:

Title

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Time Frame

At Days 1, 4, 8 and 31

Title

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.

Time Frame

At Days 1, 31, 34, 38 and 61

Title

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Description

Time Frame

At Days 1, 4, 8, 31, 34, 38 and 61

Title

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Description

Time Frame

At Days 1, 4, 8, 31, 34, 38 and 61

Title

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

Description

Time Frame

At Days 1, 4, 8 and 31.

Title

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

Description

Time Frame

At Days 1, 31, 34, 38 and 61

Title

GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

Time Frame

At Days 4, 8 and 31 versus Day 1.

Title

GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.

Time Frame

At Days 31, 34, 38 and 61 versus Day 1.

Title

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 19 and 20 and are considered final in Company's judgement.

Time Frame

At Day 61

Title

Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.

Description

Time Frame

At Day 61

Title

Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.

Description

Time Frame

At Day 61

Title

GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

Time Frame

At Day 61

Title

GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.

Description

Time Frame

Day 61 versus Day 1 (baseline)

Title

Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination

Description

Time Frame

Within 30 min after each vaccination

Title

Number of Subjects With Any Solicited Local Symptoms

Description

Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site.

Time Frame

From Day 1 (6 hours) to Day 7 after each vaccination

Title

Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data

Description

Time Frame

From Day 1 (6 hours) to Day 7 after each vaccination

Title

Number of Subjects With Unsolicited Adverse Events (AEs).

Description

Time Frame

From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

Title

Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.

Description

Time Frame

During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

Title

Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.

Description

The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination.

Time Frame

From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)

Title

Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period.

Description

Time Frame

During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

23 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1 (NCT01367158) study and who received no other meningococcal vaccines; Or A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102_02 (NCT01210885) study and have not previously received any meningococcal vaccine. Individuals who / whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including blood draws and follow-up. Males Or Females of non-childbearing potential Or Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination Exclusion Criteria: History of any meningococcal vaccine administration (study group C) or History of any meningococcal vaccine administration other than vaccination given in the parent V102_02 (NCT01210885) study (study groups A and B). Progressive, unstable or uncontrolled clinical conditions. Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study. Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws. Abnormal function of the immune system resulting from: a.Clinical conditions. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. Received immunoglobulins or any blood products within 90 days prior to enrollment. Received an investigational or non-registered medicinal product within 30 days prior to enrollment. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines. Study personnel as an immediate family or household member. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment. Who have received systemic antibiotic treatment within 3 days prior to enrollment. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or 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

Santiago

ZIP/Postal Code

8860000

Country

Chile

Facility Name

GSK Investigational Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogota

Country

Colombia

Facility Name

GSK Investigational Site

City

Panama City

ZIP/Postal Code

081600383

Country

Panama

Facility Name

GSK Investigational Site

City

Panama City

ZIP/Postal Code

0834 00363

Country

Panama

Facility Name

GSK Investigational Site

City

Panama City

ZIP/Postal Code

0843 01103

Country

Panama

Facility Name

GSK Investigational Site

City

Panama City

Country

Panama

12. IPD Sharing Statement

Citations:

PubMed Identifier

29601256

Citation

Saez-Llorens X, Beltran-Rodriguez J, Novoa Pizarro JM, Mensi I, Keshavan P, Toneatto D. Four-year antibody persistence and response to a booster dose of a pentavalent MenABCWY vaccine administered to healthy adolescents and young adults. Hum Vaccin Immunother. 2018 May 4;14(5):1161-1174. doi: 10.1080/21645515.2018.1457595. Epub 2018 May 9.

Results Reference

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