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)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Meningococcal; Meningococcal Disease

Treatments: Biological: MenABCWY+OMV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02451514

205213

2016-004420-29 (EudraCT Number)

V102_02E2 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 129 patients

Sex: All

Ages: 15 to 23 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

129 participants in 3 patient groups

MenABCWY+OMV Group

Experimental group

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.

Treatment:

Biological: MenABCWY+OMV vaccine

MenACWY Group

Experimental group

Description:

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.

Treatment:

Biological: MenABCWY+OMV vaccine

Naive Group

Experimental group

Description:

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.

Treatment:

Biological: MenABCWY+OMV vaccine