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Also known as Meningococcal Polysaccharide Tetanus Protein Conjugate
Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine · 3 trials · 6 indications
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | EXPERIMENTAL | Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0. |
| Group 2: Menomune® A/C/Y/W 135 vaccine | ACTIVE_COMPARATOR | Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0. |
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Group 5 | EXPERIMENTAL | - |
| Group 6 | ACTIVE_COMPARATOR | - |
| Group 7 | EXPERIMENTAL | Infants receiving High Dose TetraMen-T without adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months |
| Group 8 | ACTIVE_COMPARATOR | Infants receiving Menjugate ®. Subjects were to receive a booster dose of low-dose adjuvanted TetraMen-T at age 13 months. Routine vaccines were deferred. |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine | BIOLOGICAL | 0.5 milliliter (mL), Intramuscular (IM) |
| Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) |
| Meningococcal Polysaccharide Tetanus Protein Conjugate | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal polysaccharide group C conjugated | DIETARY_SUPPLEMENT | 0.5 mL, Intramuscular |
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). | BIOLOGICAL | Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM) |
| Meningococcal Group C-CRM197 Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM) |
Inclusion Criteria: * Aged 56 or older on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and complied with all trial procedures. Exclusion Criteria: * Participant was pregnant, or lactating, or of childbearing potential (were conside...
It is a vaccine developed by Sanofi for immunization against meningococcal disease and meningitis. It is a conjugate vaccine that combines meningococcal polysaccharides from groups A, C, Y and W-135 with a tetanus protein carrier. It is designed to protect against invasive meningococcal infections.
It is used for meningococcal immunization and the prevention of meningitis and invasive meningococcal disease. The vaccine targets meningococcal groups A, C, Y and W-135. Clinical studies have evaluated it in infants, toddlers, and adults aged 56 and older, including healthy volunteers.
Sanofi develops the Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the clinical trials evaluating this quadrivalent meningococcal conjugate vaccine.
The Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine is in Phase 2 development. It is an investigational vaccine and is not approved. Two completed trials have evaluated it, with a combined enrollment of 661 participants, and both were randomized, double-blind, and active-controlled.
Two completed trials have studied the Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine. NCT01732627 was a Phase 2 study in subjects aged 56 and older in the United States. NCT06165276 was a Phase 1 study in infants from 60 days of age. A third listed study, NCT00631995, evaluated a quadrivalent meningococcal tetanus protein conjugate vaccine in toddlers in Australia.
Yes. The Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine is also known as TetraMen-T, short for Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine. It is also referred to as the Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine.