Phase 3
N=1,610
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Meningococcal Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT03135834 ↗Enrolled (actual)
1,610
Serious AEs
1.7%
Results posted
Aug 2023
Primary outcome: Primary: Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) — 74.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenABCWY (Biological); Saline (Biological); rLP2086 (Biological); MenACWY-CRM (Biological)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
74.3 | — |
| PRIMARY Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
73.8; 95.0; 67.4; 86.4 | — |
| PRIMARY Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) |
16.9; 6.8; 8.0; 2.0; 17.0; 9.8 | — |
| PRIMARY Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) |
14.7; 5.2; 8.4; 1.1; 14.3; 6.4 | — |
| PRIMARY Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) |
6.7; 4.0; 2.1; 0.6; 0.0; 51.9 | — |
| PRIMARY Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) |
3.2; 1.9; 0.7; 0.7; 0.0; 45.2 | — |
| PRIMARY Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) |
18.6 | — |
| PRIMARY Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) |
14.4 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) |
0.0 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) |
0.0 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) |
0.0 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) |
0.8 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined) |
0.5 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined) |
1.3 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) |
6.3 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) |
8.8 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) |
13.3 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) |
26.7 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined) |
16.6 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined) |
33.7 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) |
0.3 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) |
0.2 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined) |
0.5 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) |
0.8 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined) |
0.3 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4) |
0.9 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) |
13.8 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) |
14.7 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) |
24.1 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined) |
40.7 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined) |
0.9 | — |
| PRIMARY Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined) |
0.3 | — |
| PRIMARY Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) |
171 | — |
| PRIMARY Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 |
13.6; 28.6; 21.6; 25.5; 5.1; 11.4 | — |
| PRIMARY Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 |
5.0; 2.6; 0.0; 1.8; 1.7; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4 |
16.7; 20.5; 13.2; 10.7 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4 |
0.0; 0.0; 0.0; 1.8 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4 |
0.0; 0.0; 2.6; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4 |
0.0; 0.0; 2.6; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4 |
9.0; 5.0; 2.6; 7.1 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4 |
3.0; 13.2; 6.5; 7.1 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4 |
10.4; 15.0; 7.8; 14.3 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4 |
0.0; 0.0; 2.6; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4 |
0.0; 0.0; 2.6; 0.0 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4 |
13.4; 10.0; 10.4; 17.9 | — |
| PRIMARY Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4 |
3; 0; 3; 2 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
91.0; 99.4; 79.3; 94.5 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
91.7; 91.5; 91.0; 80.2; 54.9; 27.3 | — |
| SECONDARY Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
49.3; 139.5; 21.2; 37.8 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
95.2; 89.3; 83.4; 96.8; 89.1; 90.4 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
95.8; 95.2; 92.2; 71.7; 38.0; 13.9 | — |
| SECONDARY Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) |
35.7; 46.0; 23.7; 60.7; 28.4; 53.5 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 |
99.2; 98.4; 100.0; 99.3; 92.4; 88.6 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 |
99.6; 98.4; 100.0; 99.3; 99.2; 98.4 | — |
| SECONDARY Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 |
215.8; 203.2; 568.6; 916.1; 111.5; 81.4 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 |
98.4; 99.3; 100.0; 99.5; 88.6; 99.4 | — |
| SECONDARY Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 |
98.4; 99.3; 100.0; 99.5; 98.4; 99.3 | — |
| SECONDARY Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3 |
203.2; 916.1; 151.3; 337.3; 81.4; 827.0 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
91.0; 91.0; 98.6; 99.4; 84.3; 79.3 | — |
| SECONDARY Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) |
75.8; 73.8; 94.7; 95.0; 76.1; 67.4 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
91.9; 91.7; 91.7; 91.5; 91.0; 91.0 | — |
| SECONDARY Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
51.0; 49.3; 152.3; 139.5; 26.6; 21.2 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 |
15.9; 22.9; 53.9; 52.6; 91.6; 86.2 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 |
26.3; 33.3; 64.4; 65.8; 15.9; 22.9 | — |
| SECONDARY Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 |
5.7; 6.3; 11.0; 10.7; 42.7; 47.2 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
25.3; 25.1; 41.6; 41.9; 13.8; 12.8 | — |
| SECONDARY Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
34.7; 36.6; 31.9; 31.8; 25.3; 25.1 | — |
| SECONDARY Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) |
10.8; 10.7; 13.7; 13.8; 5.2; 5.3 | — |
| SECONDARY Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 |
91.1; 71.2; 97.9; 100.0; 88.1; 70.0 | — |
| SECONDARY Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) |
32.7; 26.5; 36.7; 28.9; 29.2; 25.9 | — |
| SECONDARY Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined) |
95.1; 93.8; 100.0; 98.8; 95.1; 95.2 | — |
| SECONDARY Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 |
19.7; 14.9; 7.4; 5.6; 10.0; 7.4 | — |
| SECONDARY Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 |
23.0; 19.3; 7.0; 6.9; 11.7; 9.0 | — |
| SECONDARY Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 |
7.4; 5.2; 4.1; 4.1; 2.2; 0.7 | — |
| SECONDARY Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 |
3.5; 1.7; 2.2; 0.9; 1.3; 0.9 | — |
| SECONDARY Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3 |
20.8; 13.8 | — |
| SECONDARY Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3 |
17.8; 13.3 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3 |
0.0; 0.7 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3 |
0.4; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3 |
0.4; 0.7 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3 |
0.4; 1.8 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3 |
0.8; 0.4 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3 |
1.5; 2.2 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3 |
4.8; 5.9 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3 |
5.8; 9.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3 |
9.6; 13.3 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 |
23.9; 28.4 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3 |
13.8; 18.8 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3 |
30.9; 35.1 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3 |
0.0; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3 |
0.0; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3 |
0.0; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3 |
0.7; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3 |
0.4; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3 |
1.1; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3 |
15.1; 11.1 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3 |
16.1; 12.3 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3 |
25.7; 19.9 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 |
41.5; 36.9 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3 |
0.0; 0.0 | — |
| SECONDARY Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3 |
0.0; 0.0 | — |
| SECONDARY Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 |
38; 46 | — |
Summary
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Eligibility Criteria
Inclusion Criteria
- Male or female subject aged >=10 and <26 years at the time of enrollment.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
- Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup
Exclusion Criteria
- Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Data sourced from ClinicalTrials.gov (NCT03135834). 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.