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Also known as Menactra®, ProQuad®, Prevnar®, Mneactra®
Meningococcal polysaccharide diphtheria toxoid conjugate · 9 trials · 10 indications
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: \>0 to \<25 mm, Grade 2: \>=25 to \<50 mm, Grade 3: \>=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated \[children\], no interference with activity \[adolescents and adults\]; Grade 2: sufficiently discomforting \[children\], some interference\[adolescents and adults\]; Grade 3: unable to perform usual activities\[children\]; significant interference with daily activities \[adolescents and adults\]), Erythema and Swelling (Grade 1: \>0 to\<25 mm \[children\], \>=25 to \<=50 mm \[adolescents and adults\]; Grade 2: \>=25 to \<50 mm \[children\], \>=51 to \<=100 mm \[adolescents and adults\], Grade 3: \>=50 mm \[children\]; \>100 mm\[adolescents and adults\]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.
Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.5 degree Celsius; Grade 2: \>38.5 degree Celsius to \<=39.5 degree Celsius; Grade 3: \>39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: \>=6 episodes per 24 hours), Crying abnormal (Grade 1: \<1 hour; Grade 2: 1-3 hours; Grade 3: \>3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses \>=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.4 degree Celsius; Grade 2: \>=38.5 degree Celsius to \<=38.9 degree Celsius; Grade 3: \>=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
| Arm | Type | Description |
|---|---|---|
| Menactra® Group | EXPERIMENTAL | Participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) |
| Tdap - Adacel® Group | ACTIVE_COMPARATOR | Participants will receive Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) |
| Adults Study Group | EXPERIMENTAL | Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine. |
| Adolescents Study Group | EXPERIMENTAL | Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine. |
| Children Study Group | EXPERIMENTAL | Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine. |
| Study Group | EXPERIMENTAL | Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled. |
| Group 1: Menactra® Vaccine | EXPERIMENTAL | Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively. |
| Group 2: Menactra® + MMRV | EXPERIMENTAL | Participants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months |
| Group 3: Menactra® + PCV | EXPERIMENTAL | Participants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months |
| Menactra® Vaccine (9 to 23 Months) | EXPERIMENTAL | Participants (infants and toddlers) received 2-dose series of study vaccine with 3-month interval (first dose at Day 0 and second dose 3 months after dose 1). |
| Menactra® Vaccine (2 to 55 Years) | EXPERIMENTAL | Participants (children, adolescents and adults) received 1 dose of study vaccine at Day 0. |
| One-Dose Menactra Group | EXPERIMENTAL | Participants received one dose of Menactra® in Study MTA26 |
| Two-Dose Menactra Group | EXPERIMENTAL | Participants received two doses of Menactra® in Study MTA26 |
| Menactra vaccine-naïve Group | ACTIVE_COMPARATOR | Participants had never received Menactra® vaccine. |
| Menactra® Vaccine Group 1 | EXPERIMENTAL | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
| Menactra® Vaccine Group 2 | EXPERIMENTAL | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination |
| Meningococcal Vaccine-naive Group 3 | ACTIVE_COMPARATOR | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
| Meningococcal Vaccine-naive Group 4 | ACTIVE_COMPARATOR | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| Menomune® Group | EXPERIMENTAL | Received Menomune® vaccine in Study MTA02 |
| Control Group | EXPERIMENTAL | Meningococcal vaccine-naïve Control Group. |
| Menactra® Vaccine Group | EXPERIMENTAL | Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine |
| Hiberix® Vaccine Group | ACTIVE_COMPARATOR | Participants receiving Haemophilus Influenzae Type b (Hib) vaccine |
| Name | Type | Description |
|---|---|---|
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal polysaccharide diphtheria toxoid conjugate | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular. 2 doses 3 months apart |
| Haemophilus Influenzae Type b (Hib) vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 11 to 55 years on the day of inclusion * Subject aged 11 to 19 years: assent form signed and dated by the subject and informed consent form signed and dated by at least 1 parent or another legal representative * Subject aged 20 to 55 years: informed consent form signed an...
It is a vaccine used to help prevent meningococcal disease, including meningitis and meningococcal infection. It covers serogroups A, C, Y and W-135. The vaccine is given to healthy subjects, with clinical studies enrolling people from 9 months of age and older.
Sanofi develops and manufactures this vaccine, which is marketed under the brand name Menactra. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is part of Sanofi's infectious disease portfolio and has been studied in multiple countries including Vietnam, South Korea, Japan and India.
The vaccine has completed Phase 3 clinical development. Seven trials are listed for this vaccine, all of which are completed, including Phase 2 and Phase 3 studies. No trials are currently active. The completed studies together enrolled approximately 1,394 participants.
Completed trials include NCT01642589, a Phase 3 study in South Korea comparing Menactra with Adacel in subjects 11 to 55 years old, and NCT01519713, a Phase 3 single-dose study in Japanese subjects. NCT01086969 was a Phase 3 study in India, and NCT02640404 was a Phase 2 safety study in Vietnam.
Yes. Menactra is the brand name for the meningococcal (Groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine. Other names used for the same product include meningococcal polysaccharide diphtheria toxoid conjugate vaccine and meningococcal polysaccharide (serogroups A, C, Y and W-135) diphtheria toxoid conjugate vaccine.
The trials were randomized, double-blind and active-controlled, with healthy volunteers as participants. Studies covered a range of ages, starting at 9 months in the Vietnam Phase 2 trial and 2 years in the Japan and India Phase 3 trials. The South Korea Phase 3 trial enrolled subjects 11 years and older.