Phase 2
N=623
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
Meningococcal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT00310817 ↗Enrolled (actual)
623
Serious AEs
7.3%
Results posted
Nov 2015
Primary outcome: Primary: Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age — 2; 1; 75; 55 percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MenACWY-CRM conjugate vaccine, adjuvanted (Biological); MenACWY polysaccharide vaccine (Biological); MenACWY-CRM conjugate vaccine, unadjuvanted (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
2; 1; 75; 55; 14; 10 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
2; 0; 61; 39; 5; 8 | — |
| SECONDARY hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
2.06; 2.03; 15; 6.82; 2.42; 2.54 | — |
| SECONDARY hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
2.84; 2.51; 2.96; 2.78; 5.06; 4.3 | — |
| SECONDARY Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
23; 13; 19; 14; 45; 42 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age |
10; 9; 16; 14; 32; 24 | — |
| SECONDARY hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age |
51; 149; 72; 116; 129; 472 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age |
92; 98; 100; 94; 100; 100 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age |
90; 98; 97; 94; 96; 100 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
26; 14; 18; 9; 56; 34 | — |
| SECONDARY hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
2; 2; 18; 13; 2.16; 2.05 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
0; 0; 72; 61; 3; 1 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
100; 96; 100; 95; 98; 96 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
98; 85; 98; 90; 97; 90 | — |
| SECONDARY hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
107; 39; 117; 104; 84; 61 | — |
| SECONDARY hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age |
3.54; 2.54; 2.66; 2.41; 10; 4.02 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
26; 14; 18; 9; 56; 34 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age |
21; 13; 11; 7; 51; 25 | — |
| SECONDARY hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
168; 328; 141; 66; 575; 586 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
100; 96; 100; 95; 98; 96 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age |
100; 96; 100; 91; 98; 96 | — |
| SECONDARY hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age |
5.24; 4.15; 13; 18; 29; 25 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age |
43; 29; 66; 73; 89; 87 | — |
| SECONDARY Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age |
38; 23; 59; 63; 87; 85 | — |
| SECONDARY Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination |
100; 109; 70; 48; 73; 79 | — |
| SECONDARY Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination |
117; 99; 64; 41; 9; 9 | — |
Summary
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
Eligibility Criteria
Inclusion Criteria
- healthy 12-<60 month old children;
Exclusion Criteria
- subjects who have previously received any meningococcal vaccine
- subjects with any serious acute or chronic progressive disease
Data sourced from ClinicalTrials.gov (NCT00310817). 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.