Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Low-dose experimental vaccine
Experimental vaccine · 5 trials · 3 indications
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Incidence of adverse reactions within 30 days after each dose
GMT 30 days after primary immunization in msIPV vaccination group
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
| Arm | Type | Description |
|---|---|---|
| experimental group | EXPERIMENTAL | - |
| active comparator group | ACTIVE_COMPARATOR | - |
| Safety group in adults | EXPERIMENTAL | 24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. |
| Safety group in children | EXPERIMENTAL | 24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. |
| Safety group in infants | EXPERIMENTAL | 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months to evaluate the safety of msIPV vaccine . |
| Experimental Vaccine-lot 1 | EXPERIMENTAL | 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 1 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. |
| Experimental Vaccine-lot 2 | EXPERIMENTAL | 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 2 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. |
| Experimental Vaccine-lot 3 | EXPERIMENTAL | 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 3 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. |
| IPV control group | ACTIVE_COMPARATOR | 300 infants will receive 4 doses of IPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. |
| single-person sIPV control group | ACTIVE_COMPARATOR | 300 infants will receive 4 doses of single-dose sIPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. |
| Name | Type | Description |
|---|---|---|
| experimental vaccine | BIOLOGICAL | Group ACYW135 Meningococcal Conjugate Vaccine |
| Active Comparator vaccine | BIOLOGICAL | Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) |
| IPV control vaccine | BIOLOGICAL | Inactivated Poliovirus Vaccine - control vaccine produced by Sanofi. Inactivated poliovirus antigens: Mahoney strain for type 1 (40DU), MEF-1 strain for type 2 (8DU), Saukett strains for type 3 (32DU) in 0.5 ml mixture of 2- phenoxyethanol,ethanol,formaldehyde,hanks199 medium (containing amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injection),hydrochloric acid or sodium hydroxide (for pH value adjustment),trace amounts of antibiotics (neomycin, streptomycin and polymyxin B)for per injection. |
| single-person sIPV control vaccine | BIOLOGICAL | Sabin Inactivated Poliovirus Vaccine (Vero cell) (0.5ml) -control vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen: type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 0.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate for per injection. |
Inclusion Criteria: 1. Healthy participants aged 3 to 5 months. 2. The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form. 3. Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures. 4. Pr...
The Experimental vaccine is an investigational vaccine being developed for the prevention of Epidemic Meningitis, specifically meningococcal disease caused by groups A, C, Y, and W135. It is also being studied for use in Poliomyelitis and Herpes Zoster, though its primary clinical trials focus on meningococcal conjugate vaccination in children.
The Experimental vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVA. The company is conducting Phase 3 clinical trials for this vaccine candidate in China.
The Experimental vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. All four of its registered clinical trials are Phase 3 studies, with three actively recruiting participants and one active but not recruiting.
The Experimental vaccine is being evaluated in four Phase 3 clinical trials in China, all studying its use against Epidemic Meningitis. These trials are NCT07505810 (children aged 3-5 months), NCT07505823 (children aged 6-11 months), NCT07505836 (children aged 12-23 months), and NCT07505888 (children aged 2-6 years).
Yes, the Experimental vaccine is also known as the Low-dose experimental vaccine. This alternative name may be used in some contexts to refer to the same vaccine candidate being developed by Sinovac Biotech for meningococcal disease prevention.
The Experimental vaccine is a meningococcal conjugate vaccine designed to protect against Neisseria meningitidis serogroups A, C, Y, and W135. By presenting these bacterial antigens to the immune system, it stimulates the production of protective antibodies that can prevent meningococcal infection and the associated epidemic meningitis.