Clinical trial · Interventional
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Meningococcal Meningitis | — | UNRESOLVED | — |
| Pertussis | — | UNRESOLVED | — |
| Tetanus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novartis Meningococcal ACWY Conjugate Vaccine | Biological | — | UNRESOLVED |
| Tdap Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MenACWY + Tdap + HPV
- description
- Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
- interventionNames
- Biological: Novartis Meningococcal ACWY Conjugate Vaccine
- type
- EXPERIMENTAL
- label
- MenACWY →Tdap → HPV
- description
- Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8
- interventionNames
- Biological: Novartis Meningococcal ACWY Conjugate Vaccine
- type
- EXPERIMENTAL
- label
- Tdap →MenACWY → HPV
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy adolescents 11-18 years of age * virgins (both male and female) with no intention of becoming sexually active during the study period * who have been properly vaccinated against diphtheria, tetanus, pertussis Exclusion Criteria: * who had a previous confirmed or suspected disease caused by N. meningitidis; * who have previously been immunized with a meningococcal vaccine * who have received prior human papillomavirus (HPV) vaccine; * who have any serious acute, chronic or progressive disease * who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; * who have a known or suspected impairment/alteration of immune function, either congenital or acquired * who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; * who have Down's syndrome or other known cytogenic disorders;
References
Publications (1)
- RESULTArguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26. PMID 20189491