Back to results

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

Primary Purpose

Meningococcal Disease, Meningococcal Meningitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal disease, vaccines, children, persistence

Eligibility Criteria

48 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A. Inclusion Criteria for naïve subjects, newly enrolled (B48_50):

4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old.
For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
In good health as determined by medical history, physical examination, clinical judgment of the investigator.

B. Inclusion Criteria for follow-on participants (Groups B+R246 12_48, B+R246 18_48, B+R246 24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48, B12 14_48, B18 20_48, B24 26_48):

Inclusion criteria are the same as for Group B48_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.

Exclusion Criteria:

A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7):

Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study.
History of any meningococcal B vaccine administration.
Previous ascertained or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
History of allergic reaction to any vaccine component.
Significant chronic infection.
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
Family members and household members of research staff.
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

B. Exclusion Criteria for follow-on participants ((Groups B+R246 12_48, B+R246 18_48, B+R246 24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48, B12 14_48, B18 20_48, B24 26_48):

Exclusion criteria are the same as for Group B48_50, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 9.

Sites / Locations

Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Nemocnice Náchod
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Fakulta vojenskeho zdravotnictvi UO
Ordinace praktickeho lekare pro deti a dorost
Ordinace praktickeho lekare pro deti a dorost
Universita di Firenze -Pediatria
IRCCS Cà Granda
Ospedale Maggiore della Carita
Dip Pediatria AO Padova
Hospital Clinico Universitario de Santiago de Compostela
Hospital Universitario Dr. Peset
Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
Complexo Hospitalario Xeral Cies
Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
North Bristol NHS Trust
Royal Devon and Exeter NHS Foundation Trust
St Georges Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Arm Label

B+R246_12_48

B+R246_18_48

B+R246_24_48

B246_12_48

B246_18_48

B246_24_48

B+R234_12_48

B+R234_18_48

B+R234_24_48

B12 14_48

B18 20_48

B24 26_48

B48_50

Arm Description

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 12 and14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, two months apart, in the present study.

Outcomes

Primary Outcome Measures

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8. The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).

Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.

Secondary Outcome Measures

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.

GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.

Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.

GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.

Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.

Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.

Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.

The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.

Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine

The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported. Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.

Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.

The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age. Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains. Immune sufficiency was not applicable for M10713 strain.

GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.

Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.

Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.

Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Number of Subjects Reporting Unsolicited AEs After Any Vaccination.

Full Information

NCT ID

NCT01717638

First Posted

October 18, 2012

Last Updated

December 29, 2014

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01717638

Brief Title

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

Official Title

A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1. In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1. Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease, Meningococcal Meningitis

Keywords

Meningococcal disease, vaccines, children, persistence

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

805 (Actual)

8. Arms, Groups, and Interventions

Arm Title

B+R246_12_48

Arm Type

Experimental

Arm Description

Arm Title

B+R246_18_48

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Arm Title

B+R246_24_48

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Arm Title

B246_12_48

Arm Type

Experimental

Arm Description

Arm Title

B246_18_48

Arm Type

Experimental

Arm Description

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Arm Title

B246_24_48

Arm Type

Experimental

Arm Description

Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Arm Title

B+R234_12_48

Arm Type

Experimental

Arm Description

Arm Title

B+R234_18_48

Arm Type

Experimental

Arm Description

Arm Title

B+R234_24_48

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.

Arm Title

B12 14_48

Arm Type

Experimental

Arm Description

Arm Title

B18 20_48

Arm Type

Experimental

Arm Description

Arm Title

B24 26_48

Arm Type

Experimental

Arm Description

Arm Title

B48_50

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Other Intervention Name(s)

rMenB+OMV NZ

Intervention Description

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose

Intervention Type

Biological

Intervention Name(s)

2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Other Intervention Name(s)

rMenB+OMV NZ

Intervention Description

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 1 (24-36 months post booster; baseline for naive)

Title

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

Description

Time Frame

Day 1 (24-36 months post booster; baseline for naive)

Title

Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

Description

Time Frame

Day 1 (24-36 months post booster dose; baseline for naive)

Secondary Outcome Measure Information:

Title

Description

Time Frame

Day 1 (22-34 months post last MenB vaccine)

Title

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

Description

Time Frame

Day 1 (22-36 months post last MenB vaccine; baseline for naive)

Title

GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

Description

Time Frame

Day 1 (22-34 months post last MenB vaccine)

Title

Description

Time Frame

Day 31 (1 month post vaccination)

Title

GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

Description

Time Frame

Day 31 (1 month post vaccination)

Title

Description

Time Frame

Day 31 (1 month post vaccination)

Title

Description

Time Frame

Day 31 (1 month post vaccination)

Title

Description

Time Frame

Day 31 (1 month post vaccination)

Title

GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

Description

Time Frame

Day 31 (1 month post vaccination)

Title

GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.

Description

Time Frame

Day 31 (1 month post vaccination)

Title

Description

Time Frame

Day 31 (1 month post vaccination)

Title

Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.

Description

Time Frame

Day 91 (1 month post second vaccination)

Title

GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Description

The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

Time Frame

Day 91 (1 month post second vaccination)

Title

GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Description

The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.

Time Frame

Day 91 (1 month post second vaccination)

Title

Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Description

The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.

Time Frame

Day 91 (1 month post second vaccination)

Title

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Description

Time Frame

From day 1 to day 7 after vaccination

Title

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Description

Time Frame

From day 1 to day 7 after vaccination

Title

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Description

Time Frame

From day 1 to day 7 after any vaccination

Title

Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Description

The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.

Time Frame

From day 1 to study termination

Title

Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Description

Time Frame

From day 1 to study termination

Title

Number of Subjects Reporting Unsolicited AEs After Any Vaccination.

Description

Time Frame

From day 1 to study termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

48 Months

Maximum Age & Unit of Time

60 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A. Inclusion Criteria for naïve subjects, newly enrolled (B48_50): 4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old. For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study. In good health as determined by medical history, physical examination, clinical judgment of the investigator. B. Inclusion Criteria for follow-on participants (Groups B+R246 12_48, B+R246 18_48, B+R246 24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48, B12 14_48, B18 20_48, B24 26_48): Inclusion criteria are the same as for Group B48_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study. Exclusion Criteria: A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7): Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study. History of any meningococcal B vaccine administration. Previous ascertained or suspected disease caused by N. meningitidis. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis. History of allergic reaction to any vaccine component. Significant chronic infection. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition). Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants. Participation in another clinical trial within 90 days prior to enrolment or planned for during study. Family members and household members of research staff. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. B. Exclusion Criteria for follow-on participants ((Groups B+R246 12_48, B+R246 18_48, B+R246 24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48, B12 14_48, B18 20_48, B24 26_48): Exclusion criteria are the same as for Group B48_50, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 9.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Jaromer

State/Province

Alšova 466

ZIP/Postal Code

55101

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Jaromer

State/Province

Dr. E.Beneše 191

ZIP/Postal Code

55101

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Sezemice

State/Province

Havlickova 168

ZIP/Postal Code

53304

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Hronov

State/Province

Hostovského 485

ZIP/Postal Code

54931

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Ceska Skalice

State/Province

Husovo namesti 36

ZIP/Postal Code

55203

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Pardubice

State/Province

L.Male 656

ZIP/Postal Code

53012

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Hradec Králové

State/Province

Manesova 646

ZIP/Postal Code

50002

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Hronov

State/Province

Palackeho 517

ZIP/Postal Code

54931

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Hradec Králové

State/Province

Pardubicka 752

ZIP/Postal Code

50004

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Chlumec nad Cidlinou

State/Province

Pernstynska 127/I

ZIP/Postal Code

50351

Country

Czech Republic

Facility Name

Nemocnice Náchod

City

Nachod

State/Province

Purkynova 446

ZIP/Postal Code

54701

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Jindrichuv Hradec

State/Province

Ruských legií 352

ZIP/Postal Code

37701

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Pardubice

State/Province

Sladkovskeho 2617

ZIP/Postal Code

53002

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Jindrichuv Hradec

State/Province

Sídliste Vajgar 724/III

ZIP/Postal Code

37701

Country

Czech Republic

Facility Name

Fakulta vojenskeho zdravotnictvi UO

City

Hradec Kralove

State/Province

Trebesska 1575

ZIP/Postal Code

50001

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Holice

State/Province

U kaplicky 1042

ZIP/Postal Code

53401

Country

Czech Republic

Facility Name

Ordinace praktickeho lekare pro deti a dorost

City

Jindrichuv Hradec

State/Province

U nemocnice380/III

ZIP/Postal Code

37701

Country

Czech Republic

Facility Name

Universita di Firenze -Pediatria

City

Florence

ZIP/Postal Code

50139

Country

Italy

Facility Name

IRCCS Cà Granda

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Ospedale Maggiore della Carita

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Dip Pediatria AO Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Hospital Clinico Universitario de Santiago de Compostela

City

Santiago de Compostela A Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Universitario Dr. Peset

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir

City

Valencia

ZIP/Postal Code

46020/46001

Country

Spain

Facility Name

Complexo Hospitalario Xeral Cies

City

Vigo Pontevedra

ZIP/Postal Code

36204

Country

Spain

Facility Name

Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital

City

Oxford

State/Province

Headington

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

North Bristol NHS Trust

City

Bristol

ZIP/Postal Code

BS1 3NU

Country

United Kingdom

Facility Name

Royal Devon and Exeter NHS Foundation Trust

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

St Georges Hospital

City

London

ZIP/Postal Code

SW17 0RE

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29038320

Citation

Sadarangani M, Sell T, Iro MA, Snape MD, Voysey M, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, Odueyungbo A, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules. CMAJ. 2017 Oct 16;189(41):E1276-E1285. doi: 10.1503/cmaj.161288.

Results Reference

derived

Learn more about this trial

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

We'll reach out to this number within 24 hrs