Phase 2
N=163
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01027351 ↗Enrolled (actual)
163
Serious AEs
4.3%
Results posted
May 2014
Primary outcome: Primary: Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. — 3.24; 5.34; 4.25; 5.11 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine. (Biological); Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. |
3.24; 5.34; 4.25; 5.11; 28; 1.11 | — |
| PRIMARY Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. |
45; 65; 63; 43; 76; 3 | — |
| PRIMARY Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. |
28; 19; 14; 8; 17; 14 | — |
| SECONDARY Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. |
3.59; 3.47; 4.25; 9.57; 1; 1.11 | — |
| SECONDARY Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. |
57; 38; 63; 57; 0; 3 | — |
| SECONDARY Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. |
99; 89; 12; 778; 1708; 22 | — |
| SECONDARY Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. |
100; 100; 89; 100; 100; 76 | — |
| SECONDARY Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. |
89; 94; 41; 100; 94; 68 | — |
| SECONDARY Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. |
94; 76; 12; 127; 145; 88 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. |
100; 100; 89; 100; 100; 100 | — |
| SECONDARY Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. |
100; 86; 41; 100; 100; 68 | — |
| SECONDARY Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. |
100; 93; 100; 93; 100; 100 | — |
| SECONDARY Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. |
88; 34; 1019; 865; 47; 29 | — |
| SECONDARY Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. |
97; 71; 100; 100; 94; 89 | — |
| SECONDARY Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. |
3.13; 4.68; 18; 13; 12; 2.98 | — |
| SECONDARY Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. |
46; 44; 85; 80; 71; 33 | — |
| SECONDARY Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age. |
82; 62; 23 | — |
| SECONDARY Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age. |
32; 28; 23 | — |
| SECONDARY Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age. |
5592; 3934; 64 | — |
| SECONDARY Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age. |
2100; 1764; 64; 3790; 3660; 3464 | — |
| SECONDARY Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age. |
3464; 1744 | — |
| SECONDARY Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. |
670; 320; 280; 250; 121; 25 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. |
42; 49; 41; 46; 42; 48 | — |
Summary
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.
Eligibility Criteria
Inclusion Criteria
- Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)
- Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)
Exclusion Criteria
- Previous ascertained or suspected disease caused by N. meningitidis
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
- Any serious chronic or progressive disease
- Known or suspected impairment/alteration of the immune system
- Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Data sourced from ClinicalTrials.gov (NCT01027351). 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.