Phase 3
N=5,712
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Meningitis, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT01352793 ↗Enrolled (actual)
5,712
Serious AEs
1.9%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study — 1.55; 2.52 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rLP2086 vaccine (Biological); control (Biological)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study |
1.55; 2.52 | — |
| PRIMARY Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 |
7.03; 6.13 | — |
| PRIMARY Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 |
5.50; 6.09 | — |
| PRIMARY Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 |
5.34; 5.50 | — |
| SECONDARY Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods |
0.18; 0.42; 0.17; 0.44; 0.33; 0.12 | — |
| SECONDARY Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods |
14.38; 14.57; 24.60; 24.53; 11.24; 11.43 | — |
| SECONDARY Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods |
0.21; 0.10; 0.17; 0.33; 0.09; 0.12 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods |
31.48; 19.03; 20.37; 12.35; 15.00; 10.76 | — |
| SECONDARY Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination |
1.05; 0.84; 0.54; 0.06; 0.45; 0.41 | — |
| SECONDARY Number of Days Participant Missed School or Work Due to Adverse Events (AEs) |
3.0; 3.0 | — |
Summary
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects aged 10 to 25 years.
Exclusion Criteria
- Previous vaccination with Hepatitis A virus vaccine
- Previous vaccination with investigational meningococcal B vaccine
- History of culture-proven N. meningitidis serogroup B disease
- Any neuroinflammatory or autoimmune condition
- Any immune defect that would prevent an effective response to the study vaccine
Data sourced from ClinicalTrials.gov (NCT01352793). 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.