Phase 2
N=1,885
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00721396 ↗Enrolled (actual)
1,885
Serious AEs
8.4%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine — 9; 7; 6; 6 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rMenB+OMV NZ (Biological); combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine (Biological); Pneumococcal vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine |
9; 7; 6; 6; 99; 99 | — |
| PRIMARY Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age |
529; 491; 265; 0; 506; 516 | — |
| SECONDARY Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age |
8; 7; 100; 100; 6; 7 | — |
| SECONDARY Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine |
25; 21; 100; 100; 81; 86 | — |
| SECONDARY Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. |
1.49; 1.36; 1.34; 1.28; 86; 113 | — |
| SECONDARY Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. |
58; 83; 61; 0.91; 430; 553 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine. |
4; 3; 4; 2; 99; 100 | — |
| SECONDARY Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. |
97; 99; 98; 1; 99; 99 | — |
| SECONDARY Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine. |
94; 95; 92; 95; 97; 98 | — |
Summary
Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.
Eligibility Criteria
Inclusion Criteria
- Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
- For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
Exclusion Criteria
- History of any meningococcal B or C vaccine administration;
- prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
- Previous ascertained or suspected disease caused by N. meningitidis;
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
- Antibiotics within 6 days prior to enrollment;
- Any serious chronic or progressive disease;
- Known or suspected impairment or alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Data sourced from ClinicalTrials.gov (NCT00721396). 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.