Last updated: 04/11/2025 06:21:03
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
Trial description: The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
Timeframe: Day 30
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Timeframe: Day 1 and Day 30
Secondary outcomes:
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Timeframe: Day 1 (Pre vaccination)
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Timeframe: Day 1 (Pre vaccination)
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Timeframe: Day 1 (Pre-vaccination)
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
Timeframe: Day 1 (Pre-vaccination)
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Timeframe: Day 1 and Day 30
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Timeframe: Day 1 and Day 30
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Timeframe: Day 1 and Day 30
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Timeframe: Day 1 and Day 30
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Timeframe: Day 1 and Day 30
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Timeframe: Day 30
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Timeframe: Day 1 and Day 365
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Timeframe: Day 1, Day 30 and Day 365
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Timeframe: Day 1, Day 30 and Day 365
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Timeframe: Day 1 and Day 365
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Timeframe: Day 1 and Day 365
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Timeframe: Day 1, Day 30 and Day 365
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Timeframe: Day 1, Day 30 and Day 365
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Timeframe: Day 1, Day 30 and Day 365
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
Timeframe: Day 1, Day 30 and Day 365
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Timeframe: Day 1, Day 30 and Day 365
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Timeframe: From day 1 (6 hours) through day 7 after any vaccination
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Timeframe: Day 1 through Day 30
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Timeframe: Day 1 to Day 365
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Timeframe: From primary parent study completion up to Day 1 in this study.
Interventions:
Biological/vaccine: MenABCWY+OMV
Biological/vaccine: Placebo
Biological/vaccine: MenABCWY+¼OMV
Enrollment:
194
Observational study model:
Not applicable
Primary completion date:
2014-29-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
GSK3536819A, GSK3536829A
Collaborators
Not applicable
Study date(s)
December 2013 to April 2015
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
10 - 25 Years
Accepts healthy volunteers
Yes
- 1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
- 2. Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
- 1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
- 2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180); 2. Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements; 3. Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements; 4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; 5. Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.
Exclusion criteria:
- 1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180); 2. Current or previous, confirmed or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; 4. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 5. All sexually active females that have not used an "acceptable contraceptive method(s)" for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following: 1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) 2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse 3. Intrauterine device (IUD) 4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry; 6. Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination; 7. Female subjects with a positive pregnancy test prior to the study vaccine being administered; 8. Nursing (breastfeeding) mothers; 9. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study; 10. Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition); 11. Subjects who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 20mg/day. Inhaled and topical steroids are allowed). 12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; 13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; 14. Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered >14 days preceding or >14 days following the study vaccination); 15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse. 16. Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment. 17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Trial location(s)
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Huber Heights, Ohio, United States, 45424
Status
Study Complete
Location
GSK Investigational Site
Lebanon, Tennessee, United States, 37087
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
Location
GSK Investigational Site
Madera, California, United States, 93637
Status
Study Complete
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2014-29-05
Actual study completion date
2015-17-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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