Meningococcal Immunisation, Healthy Volunteers
Conditions
Brief summary
The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants.
Detailed description
The study duration will be approximately 12 months for all participants
Interventions
BIOLOGICALPentavalent Meningococcal ABCYW vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
BIOLOGICALMenACYW conjugate vaccine
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
BIOLOGICALMeningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
BIOLOGICALPlacebo
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
BIOLOGICALMenABCYW conjugate vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
- Aged 18 to 25 years or 10 to 17 years on the day of inclusion * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator. * Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency * History of any Neisseria meningitidis infection * At high risk for meningococcal infection during the study * Individuals with active tuberculosis * History of Guillain-Barré syndrome * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with immediate adverse events (AEs) | Within 30 minutes after each vaccination | Unsolicited systemic AEs that occur within 30 minutes after vaccination |
| Number of participants with solicited injection site reactions or systemic reactions | Within 7 days after each vaccination | Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF |
| Number of participants with unsolicited AEs | Within 30 days after each vaccination | Non-serious AEs other than solicited reactions |
| Number of participants with serious adverse events (SAEs) | From baseline up to 12 months | SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study |
| Number of participants with medically attended adverse events (MAAEs) | From baseline up to 12 months | An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department |
| Number of participants with out-of-range biological test results | Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group | — |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ) |
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants | Day 211 (for Group 1 to 7) | hSBA titers ≥ 1:8 |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants | Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7) | Geometric mean titers |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants | Day 01 (pre-dose) Day 211 (for Group 1 to 7) | — |
| hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | Seroresponse defined as a 4-fold increase in hSBA titers |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | hSBA titers ≥ 1:4 for reference MenB strains |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | hSBA titers ≥ 1:8 for reference MenB strains |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | Geometric mean titers for the reference MenB strains |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers \< 1:4 or post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with pre-dose 1 vaccination titers more than the lower limit of quantification (LLOQ) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | — |
| hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | hSBA titers ≥ 1:8 post-vaccination |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | Geometric mean titers |
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | — |
| hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | Seroresponse defined as a 4-fold increase in hSBA titers |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | hSBA titers ≥ 1:4 for reference MenB strains |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | hSBA titers ≥ 1:8 reference MenB strains |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | Geometric mean titers for reference MenB strains |
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) | — |
| hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) | Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) | hSBA titers ≥ 1:4 for reference and additional MenB strains |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) | hSBA titers ≥ 1:8 for reference and additional MenB strains |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) | Geometric mean titers for reference and additional MenB strains |
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) | — |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) | Seroresponse defined as post-third vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-third vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than the lower limit of quantification (LLOQ) |
Countries
Puerto Rico, United States
Outcome results
None listed