Meningococcal DiseasePhase 2NCT02451514

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)

A Phase 2 study testing MenABCWY+OMV vaccine in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 23 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Infections, Meningococcal
What is being tested?: MenABCWY+OMV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 7 sitesin 3 countries
Study dates: 30 Jun 2015to 10 Dec 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 23 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Panama4 sites

GSK Investigational Site
Panama City, 081600383
GSK Investigational Site
Panama City, 0834 00363
GSK Investigational Site
Panama City, 0843 01103
GSK Investigational Site
Panama City

Other trials in Panama

Colombia2 sites

GSK Investigational Site
Bogotá, 110221
GSK Investigational Site
Bogotá

Other trials in Colombia

Chile1 site

GSK Investigational Site
Santiago, 8860000

Other trials in Chile

About this study

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)

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

Read the detailed description

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

Conditions: Meningococcal Disease, Infections, Meningococcal
Being tested: MenABCWY+OMV vaccine
Keywords: Antibody persistence, Young Adults, Healthy Adolescents, MenABCWY vaccine, Booster response, MenABCWY+OMV
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MenABCWY+OMV vaccineBiological
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.

Study groups in NCT02451514
Study group	Role	What they receive
MenABCWY+OMV Group	Experimental	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. Receives: Biological: MenABCWY+OMV vaccine
MenACWY Group	Experimental	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. Receives: Biological: MenABCWY+OMV vaccine
Naive Group	Experimental	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. Receives: Biological: MenABCWY+OMV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Day 1 (4 years persistence)
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.
Measured: At Day 1 (4 years persistence)
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.
Measured: At Day 1 (4 years persistence)
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.
Measured: At Day 1
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.
Measured: At Day 31
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.
Measured: At Day 31
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.
Measured: At Day 31
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.
Measured: At Day 31
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.
Measured: Day 31 versus Day 1

Secondary outcomes (20)

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.
Measured: At Days 1, 4, 8 and 31
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.
Measured: At Days 1, 31, 34, 38 and 61
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.
Measured: At Days 1, 4, 8, 31, 34, 38 and 61
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.
Measured: At Days 1, 4, 8, 31, 34, 38 and 61
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.
Measured: At Days 1, 4, 8 and 31.
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.
Measured: At Days 1, 31, 34, 38 and 61
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.
Measured: At Days 4, 8 and 31 versus Day 1.
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.
Measured: At Days 31, 34, 38 and 61 versus Day 1.
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.
Measured: At Day 61
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.
Measured: At Day 61
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.
Measured: At Day 61
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.
Measured: At Day 61
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.
Measured: Day 61 versus Day 1 (baseline)
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.
Measured: Within 30 min after each 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.
Measured: From Day 1 (6 hours) to Day 7 after each vaccination
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.
Measured: From Day 1 (6 hours) to Day 7 after each vaccination
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 201510 Dec 2015

First posted22 May 2015 (estimated)
Study start30 Jun 2015
Primary completion14 Nov 2015
Study completion10 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02451514
Sponsor's protocol ID: 205213
Other IDs: 2016-004420-29, V102_02E2, 2016
Status last verified: Jun 2020
First submitted: 4 May 2015
Last updated: 9 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 29601256

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02451514
Acronym / sponsor ID: 205213
Conditions: Meningococcal Disease, Infections, Meningococcal
Keywords: Antibody persistence, Young Adults, Healthy Adolescents, MenABCWY vaccine, Booster response, MenABCWY+OMV
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jun 2015 (actual)
Primary completion: 14 Nov 2015 (actual)
Study completion: 10 Dec 2015 (actual)
First posted: 22 May 2015 (estimated)
Results: Posted 9 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenABCWY+OMV Group	Experimental	Biological: MenABCWY+OMV vaccineSubjects 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.
MenACWY Group	Experimental	Biological: MenABCWY+OMV vaccineSubjects 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.
Naive Group	Experimental	Biological: MenABCWY+OMV vaccineSubjects 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.

Who may qualify

Ages: 15 to 23 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MenABCWY+OMV vaccineIntramuscular 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.	Biological	MenABCWY+OMV Group, MenACWY Group, Naive Group

Primary outcome

Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Day 1 (4 years persistence)
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.
Time frame: At Day 1 (4 years persistence)
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.
Time frame: At Day 1 (4 years persistence)
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.
Time frame: At Day 1
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.
Time frame: At Day 31
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.
Time frame: At Day 31
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.
Time frame: At Day 31
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.
Time frame: At Day 31
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.
Time frame: Day 31 versus Day 1
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.

20 secondary outcomes

Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 1, 4, 8 and 31
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 1, 31, 34, 38 and 61
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Time frame: At Days 1, 4, 8, 31, 34, 38 and 61
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Time frame: At Days 1, 4, 8, 31, 34, 38 and 61
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 1, 4, 8 and 31.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 1, 31, 34, 38 and 61
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 4, 8 and 31 versus Day 1.
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Days 31, 34, 38 and 61 versus Day 1.
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Day 61
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Time frame: At Day 61
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Time frame: At Day 61
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: At Day 61
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
Time frame: Day 61 versus Day 1 (baseline)
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination
Time frame: Within 30 min after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs).
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)
Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.
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)
Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.
Time frame: From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period.
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)

Results and safety

Results posted to the registry on 9 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MenABCWY+OMV Group	33	33
MenACWY Group	46	46
Naive Group	50	50

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

Time frame: At Day 1 (4 years persistence)

Population analysed: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.

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

Time frame: At Day 1 (4 years persistence). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenABCWY+OMV Group n = 33	MenACWY Group n = 46	Naive Group n = 50
Serogroup A	27 (13.3 to 45.5)	41 (27.0 to 56.8)	2 (0.05 to 10.6)
Serogroup C	69 (50.0 to 83.9)	43 (28.9 to 58.9)	45 (30.7 to 59.8)
Serogroup W	75 (56.6 to 88.5)	78 (63.6 to 89.1)	53 (38.1 to 67.9)
Serogroup Y	38 (21.1 to 56.3)	59 (43.2 to 73.7)	19 (9.1 to 33.3)

Population analysed: Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.

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

Time frame: At Day 1 (4 years persistence). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenABCWY+OMV Group n = 33	MenACWY Group n = 46	Naive Group n = 50
Serogroup B, M14459	18 (7.0 to 35.5)	4 (0.5 to 14.8)	8 (2.2 to 19.2)
Serogroup B, M01-0240364	13 (3.6 to 29.8)	5 (0.6 to 15.5)	4 (0.49 to 13.7)
Serogroup B, NZ98/254	15 (5.1 to 31.9)	2 (0.06 to 11.5)	6 (1.3 to 16.5)
Serogroup B, M10713	48 (30.8 to 66.5)	33 (19.5 to 48.0)	38 (24.7 to 52.8)
Serogroup B, H44/76	27 (13.3 to 45.5)	4 (0.5 to 14.8)	10 (3.3 to 21.8)
Serogroup B, 5/99	70 (51.3 to 84.4)	17 (7.8 to 31.4)	16 (7.2 to 29.1)

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

Time frame: At Day 1. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	MenABCWY+OMV Group n = 33	MenACWY Group n = 46	Naive Group n = 50
Serogroup B, M14459	2.04 (1.46 to 2.83)	1.37 (1.12 to 1.69)	1.48 (1.18 to 1.85)
Serogroup B, M01-0240364	2.26 (1.26 to 4.08)	1.14 (0.97 to 1.35)	1.23 (1.02 to 1.47)
Serogroup B, NZ98/254	1.81 (1.30 to 2.51)	1.35 (1.15 to 1.59)	1.45 (1.18 to 1.77)
Serogroup B, M10713	3.66 (2.38 to 5.62)	2.56 (1.74 to 3.75)	3.10 (2.16 to 4.45)
Serogroup B, H44/76	2.33 (1.57 to 3.45)	1.21 (1.03 to 1.42)	1.44 (1.14 to 1.80)
Serogroup B, 5/99	13 (7.29 to 22)	1.78 (1.36 to 2.34)	1.90 (1.42 to 2.53)
Serogroup A	4.06 (2.22 to 7.44)	6.64 (3.56 to 12)	1.20 (1.05 to 1.37)
Serogroup C	17 (7.80 to 37)	6.62 (4.10 to 11)	5.11 (3.49 to 7.48)

MenABCWY+OMV Group vs MenACWY Group: Geometric mean ratio: 1.48 (95% CI 1.03 to 2.12), Miettinen & Nurminen score method
MenACWY Group vs Naive Group: Geometric mean ratio: 0.93 (95% CI 0.67 to 1.28), Miettinen & Nurminen score method
MenABCWY+OMV Group vs Naive Group: Geometric mean ratio: 1.38 (95% CI 0.97 to 1.96), Miettinen & Nurminen score method

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenABCWY+OMV Group	0 of 33 (0%)	33 of 33 (100%)	0 of 33
MenACWY Group	0 of 46 (0%)	44 of 46 (95.7%)	0 of 46
Naive Group	0 of 50 (0%)	48 of 50 (96%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29601256Saez-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenABCWY+OMV vaccine in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Panama, Colombia, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. (time frame: At Day 1 (4 years persistence)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451514, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.