Phase 2
N=484
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
Invasive Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01272180 ↗Enrolled (actual)
484
Serious AEs
1.7%
Results posted
Sep 2014
Primary outcome: Primary: Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. — 90; 92; 73; 95 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. (Biological); Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. (Biological); Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. (Biological); Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV. (Biological)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. |
90; 92; 73; 95; 93; 63 | — |
| PRIMARY Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. |
0.306; 0.325 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
8; 6; 1; 93; 95; 73 | — |
| SECONDARY The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
1.57; 1.32; 1.33; 71; 77; 45 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
9; 4; 5; 64; 71; 82 | — |
| SECONDARY Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
56; 62; 75; 79; 70; 88 | — |
| SECONDARY The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
1.32; 1.15; 1.26; 9.24; 11; 17 | — |
| SECONDARY The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. |
7.32; 9.41; 14; 48; 30; 98 | — |
| SECONDARY The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. |
57; 53; 72; 30; 46; 52 | — |
| SECONDARY The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. |
36; 36; 45; 31; 12; 10 | — |
Summary
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Eligibility Criteria
Inclusion Criteria
- Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.
Exclusion Criteria
- History of any meningococcal vaccine administration;
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Pregnant or nursing (breastfeeding) mothers;
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;
- Any serious, chronic, or progressive disease;
- Known or suspected impairment/alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.
Data sourced from ClinicalTrials.gov (NCT01272180). 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.