Phase 3
Completed N=751
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
Meningococcal Disease · Meningococcal Meningitis
Source: ClinicalTrials.gov NCT01214837 ↗
Enrolled (actual)
751
Serious AEs
5.6%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. — 96; 99; 99; 99 Percentage of subjects
Summary
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. |
96; 99; 99; 99 | — |
| PRIMARY Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. |
88; 96; 95; 99; 99; 99 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. |
NA; NA; 4; NA; 9; NA | — |
| SECONDARY Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. |
NA; NA; 2.18; NA; 2.63; NA | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. |
6; 22; 19; 48; 33; 66 | — |
| SECONDARY Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. |
2.28; 3.65; 3.54; 8.55; 5.41; 13 | — |
| SECONDARY GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. |
59; 94; 124; 160; 248; 244 | — |
| SECONDARY Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. |
88; 95; 93; 91; 98; 90 | — |
| SECONDARY Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. |
93.7; 100; 94.2; 79.3; 87.6; 82.3 | — |
| SECONDARY Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. |
2; 2.16; 2.14; 0.88; 0.97; 0.77 | — |
| SECONDARY Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. |
18; 21; 18 | — |
| SECONDARY Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. |
72; 64; 79; 60; 40; 74 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. |
219; 220; 209; 24; 32; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.
Exclusion Criteria
- Serious, acute, or chronic illnesses are reasons for exclusion.
Data sourced from ClinicalTrials.gov (NCT01214837). 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. Informational only — not medical advice.