Phase 3
N=1,620
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Meningococcal Meningitis · Human Papillomavirus Infection · Pertussis · Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT00518180 ↗Enrolled (actual)
1,620
Serious AEs
0.7%
Results posted
Oct 2010
Primary outcome: Primary: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse — 80; 82; 87; 83 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Novartis Meningococcal ACWY Conjugate Vaccine (Biological); Tdap Vaccine (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse |
80; 82; 87; 83; 84; 84 | — |
| PRIMARY Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL |
100; 100; 98; 100; 100; 100 | — |
| PRIMARY Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) |
51; 79; 63; 342; 1106; 511 | — |
| SECONDARY Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups |
62; 67; 95; 66; 70; 68 | — |
| SECONDARY Percentage of Subjects With Anti-HPV Seroconversion |
99; 100; 100; 100; 100; 100 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay |
1059; 1461; 1264; 1701; 5286; 6590 | — |
| SECONDARY Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups |
81; 82; 89; 92; 90; 93 | — |
| SECONDARY The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus |
100; 100; 98; 100; 100; 100 | — |
| SECONDARY Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus |
37; 10; 10; 8.75; 12; 10 | — |
| SECONDARY Geometric Mean Titers (GMT) of Pertussis Antigens |
51; 79; 63; 342; 1106; 511 | — |
| SECONDARY Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN |
83; 89; 86; 67; 90; 78 | — |
| SECONDARY Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. |
263; 246; 239; 367; 310; 383 | — |
| SECONDARY Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination |
265; 180; 204; 74; 36; 42 | — |
Summary
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
Eligibility Criteria
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;
Data sourced from ClinicalTrials.gov (NCT00518180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.