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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)

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ClinicalTrials.gov Identifier: NCT02451514
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Meningococcal Disease Biological: MenABCWY+OMV vaccine Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: MenABCWY+OMV Group (A)

Subjects in this group who received 2 doses of MenABCWY+OMV vaccine in the parent study and received no subsequent meningococcal vaccines, who will receive a booster dose of MenABCWY+OMV vaccine in the current study.

Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 8 and Day 31.

Biological: MenABCWY+OMV vaccine
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 vaccine-naive Groups.

Experimental: MenACWY Group (B1)

Subjects who received MenACWY vaccine in the parent study and received no subsequent meningococcal vaccines, who will receive 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study.

Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 31 (before vaccination) and Day 61.

Biological: MenABCWY+OMV vaccine
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 vaccine-naive Groups.

Experimental: MenACWY Group (B2)

Subjects who received MenACWY vaccine in the parent study and received no subsequent meningococcal vaccines, who will receive 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study.

Blood samples will be collected from subjects at Day 1 (before vaccination), Day 8, Day 31 (before vaccination) and Day 61.

Biological: MenABCWY+OMV vaccine
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 vaccine-naive Groups.

Experimental: Naive Group (C1)

Subjects who have not previously received any meningococcal vaccine, who will receive 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study.

Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.

Biological: MenABCWY+OMV vaccine
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 vaccine-naive Groups.

Experimental: Naive Group (C2)

Subjects who have not previously received any meningococcal vaccine, who will receive 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study.

Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 38 and Day 61.

Biological: MenABCWY+OMV vaccine
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 vaccine-naive Groups.




Primary Outcome Measures :
  1. Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
  2. hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
  3. Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N.meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
  4. Percentages of subjects with hSBA titers ≥ LLQ against N.meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 31 ]
  5. Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1 ]
  6. Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 31 ]
  7. Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1 ]
  8. Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 31 ]
  9. Between-group Geometric Mean Ratios (GMRs) comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
  10. Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 31 ]
  11. Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1 ]
    For MenABCWY+OMV Group, GMRs will be calculated with respect to the visit one month after the 2nd dose of MenABCWY+OMV in V102_02 (NCT02451514). For MenACWY Group, GMRs will be calculated with respect to the visit one month after the 1st dose of MenACWY in V102_02 (NCT02451514).

  12. Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 31 ]

Secondary Outcome Measures :
  1. hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1, 4, 8 and 31 for MenABCWY+OMV Group (A), MenACWY Group (B1) and MenACWY Group (B2). Day 1, 31, 34, 38 and 61 for Naive Group (C1) and Naive Group (C2). ]
  2. Percentages of subjects with hSBA titers ≥ LLQ against N. meningitides serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
  3. Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
  4. Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains. [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
  5. Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains [ Time Frame: Day 1, 4, 8, 31, 34, 38, 61 ]
  6. Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. [ Time Frame: Day 4, 8, 31, 34, 38, 61 ]
  7. Any unsolicited and solicited AEs reported [ Time Frame: Within 30 minutes after vaccination ]
  8. Solicited local (i.e., pain, erythema and induration) and systemic (i.e. chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥ 38°C (100.4°F)). [ Time Frame: From Day 1 (6 hours) to Day 7 after each vaccination ]
  9. All unsolicited AEs reported. [ 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) ]
  10. Medically-attended AEs reported [ 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) ]
  11. AEs leading to premature withdrawal from the study during the entire study period [ Time Frame: Day 1-61 ]
  12. AEs leading to premature withdrawal from the study [ 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) ]
  13. SAEs reported [ 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Individuals who can comply with study procedures including blood draws and follow-up.
  4. 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:

  1. 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).
  2. Progressive, unstable or uncontrolled clinical conditions.
  3. Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
  4. Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
  5. Abnormal function of the immune system resulting from:

    a.Clinical conditions.

  6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
  7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
  8. Received immunoglobulins or any blood products within 90 days prior to enrollment.
  9. Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
  10. 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.
  11. Study personnel as an immediate family or household member.
  12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment.
  13. Who have received systemic antibiotic treatment within 3 days prior to enrollment.
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451514


Locations
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Chile
GSK Investigational Site
Santiago, Chile, 8860000
Colombia
GSK Investigational Site
Bogota, Colombia, 110221
GSK Investigational Site
Bogota, Colombia
Panama
GSK Investigational Site
Panama City, Panamá, Panama, 081600383
GSK Investigational Site
Panama City, Panamá, Panama, 0834 00363
GSK Investigational Site
Panama City, Panamá, Panama, 0843 01103
GSK Investigational Site
Panama City, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02451514     History of Changes
Other Study ID Numbers: 205213
2016-004420-29 ( EudraCT Number )
V102_02E2 ( Other Identifier: Novartis )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by GlaxoSmithKline:
Antibody persistence
Young Adults
Healthy Adolescents
MenABCWY vaccine
Booster response
MenABCWY+OMV
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs