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

NCT01717638 | Completed Phase 3 Results

• 2 other identifiers: V72P12E22011-004931-30
• Study Type: interventional
• Target: 805
• Locations: 4 countries
• Sites: 29

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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Meningococcal disease, vaccines, children, persistence

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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).

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

• 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.

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

Secondary Outcomes (21)

• 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

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

• 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

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

• 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

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

• 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

  Day 31 (1 month post vaccination)

• 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

  Day 31 (1 month post vaccination)

Study Arms (13)

B+R246_12_48

EXPERIMENTAL

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.

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

B+R246_18_48

EXPERIMENTAL

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.

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

B+R246_24_48

EXPERIMENTAL

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.

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

B246_12_48

EXPERIMENTAL

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.

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

B246_18_48

EXPERIMENTAL

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.

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

B246_24_48

EXPERIMENTAL

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.

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

B+R234_12_48

EXPERIMENTAL

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.

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

B+R234_18_48

EXPERIMENTAL

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.

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

B+R234_24_48

EXPERIMENTAL

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.

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

B12 14_48

EXPERIMENTAL

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.

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

B18 20_48

EXPERIMENTAL

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.

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

B24 26_48

EXPERIMENTAL

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.

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

B48_50

EXPERIMENTAL

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.

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

Interventions

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

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

Also known as: rMenB+OMV NZ

B+R234_12_48; B+R234_18_48; B+R234_24_48; B+R246_12_48; B+R246_18_48; B+R246_24_48; B12 14_48; B18 20_48; B24 26_48; B246_12_48; B246_18_48; B246_24_48

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

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

Also known as: rMenB+OMV NZ

B48_50

Eligibility Criteria

• Age: 48 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (29)

Ordinace praktickeho lekare pro deti a dorost

Jaroměř, Alšova 466, 55101, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jaroměř, Dr. E.Beneše 191, 55101, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Sezemice, Havlickova 168, 53304, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hronov, Hostovského 485, 54931, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Česká Skalice, Husovo Namesti 36, 55203, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Pardubice, L.Male 656, 53012, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, Manesova 646, 50002, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hronov, Palackeho 517, 54931, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, Pardubicka 752, 50004, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Chlumec nad Cidlinou, Pernstynska 127/i, 50351, Czechia

Location

Nemocnice Náchod

Náchod, Purkynova 446, 54701, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, Ruských Legií 352, 37701, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Pardubice, Sladkovskeho 2617, 53002, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, Sídliste Vajgar 724/iii, 37701, Czechia

Location

Fakulta vojenskeho zdravotnictvi UO

Hradec Králové, Trebesska 1575, 50001, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Holice, U Kaplicky 1042, 53401, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, U nemocnice380/III, 37701, Czechia

Location

Universita di Firenze -Pediatria

Florence, 50139, Italy

Location

IRCCS Cà Granda

Milan, 20122, Italy

Location

Ospedale Maggiore della Carita

Novara, 28100, Italy

Location

Dip Pediatria AO Padova

Padua, 35128, Italy

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela A Coruña, 15706, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

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

Valencia, 46020/46001, Spain

Location

Complexo Hospitalario Xeral Cies

Vigo Pontevedra, 36204, Spain

Location

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

Oxford, Headington, OX3 7LJ, United Kingdom

Location

North Bristol NHS Trust

Bristol, BS1 3NU, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

St Georges Hospital

London, SW17 0RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29038320 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 30, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 13, 2015
• Results First Posted: January 13, 2015

Record last verified: 2014-12

Locations

GB (4); ES (4); IT (4); CZ (17)