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NeisVac-CTM
NeisVac-CTM is a Meningococcal conjugate vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of meningococcal disease caused by Neisseria meningitidis serogroup C in infants, children, and adults.
NeisVac-C is a meningococcal C conjugate vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup C.
NeisVac-CTM is a vaccine used to protect against Neisseria Meningitidis, Haemophilus Influenzae Type b, and other infections. It is a small molecule vaccine, although the exact formulation is not specified in the provided facts.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | NeisVac-CTM |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Meningococcal conjugate vaccine |
| Target | Neisseria meningitidis serogroup C polysaccharide capsule |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains polysaccharide capsular material from N. meningitidis serogroup C conjugated to a protein carrier, which enhances immunogenicity and promotes T-cell dependent immune responses. This results in the production of protective antibodies that prevent meningococcal disease caused by serogroup C strains.
Approved indications
- Prevention of meningococcal disease caused by Neisseria meningitidis serogroup C in infants, children, and adults
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
Key clinical trials
- Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines (PHASE3)
- Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NeisVac-CTM CI brief — competitive landscape report
- NeisVac-CTM updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about NeisVac-CTM
What is NeisVac-CTM?
How does NeisVac-CTM work?
What is NeisVac-CTM used for?
Who makes NeisVac-CTM?
What drug class is NeisVac-CTM in?
What development phase is NeisVac-CTM in?
What are the side effects of NeisVac-CTM?
What does NeisVac-CTM target?
Related
- Drug class: All Meningococcal conjugate vaccine drugs
- Target: All drugs targeting Neisseria meningitidis serogroup C polysaccharide capsule
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of meningococcal disease caused by Neisseria meningitidis serogroup C in infants, children, and adults
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing