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
NCT ID: NCT01717638
Last Updated: 2015-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
805 participants
INTERVENTIONAL
2012-11-30
2013-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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B+R246_12_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B+R246_18_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B+R246_24_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B246_12_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B246_18_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B246_24_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B+R234_12_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B+R234_18_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B+R234_24_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B12 14_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B18 20_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B24 26_48
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.
1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
B48_50
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.
2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
Interventions
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1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
3. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
4. In good health as determined by medical history, physical examination, clinical judgment of the investigator.
Exclusion Criteria
2. History of any meningococcal B vaccine administration.
3. Previous ascertained or suspected disease caused by N. meningitidis.
4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
5. History of allergic reaction to any vaccine component.
6. Significant chronic infection.
7. 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).
8. Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
9. Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
10. Family members and household members of research staff.
11. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
48 Months
60 Months
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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Ordinace praktickeho lekare pro deti a dorost
Jaroměř, Alšova 466, Czechia
Ordinace praktickeho lekare pro deti a dorost
Jaroměř, Dr. E.Beneše 191, Czechia
Ordinace praktickeho lekare pro deti a dorost
Sezemice, Havlickova 168, Czechia
Ordinace praktickeho lekare pro deti a dorost
Hronov, Hostovského 485, Czechia
Ordinace praktickeho lekare pro deti a dorost
Česká Skalice, Husovo Namesti 36, Czechia
Ordinace praktickeho lekare pro deti a dorost
Pardubice, L.Male 656, Czechia
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Manesova 646, Czechia
Ordinace praktickeho lekare pro deti a dorost
Hronov, Palackeho 517, Czechia
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Pardubicka 752, Czechia
Ordinace praktickeho lekare pro deti a dorost
Chlumec nad Cidlinou, Pernstynska 127/i, Czechia
Nemocnice Náchod
Náchod, Purkynova 446, Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, Ruských Legií 352, Czechia
Ordinace praktickeho lekare pro deti a dorost
Pardubice, Sladkovskeho 2617, Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, Sídliste Vajgar 724/iii, Czechia
Fakulta vojenskeho zdravotnictvi UO
Hradec Králové, Trebesska 1575, Czechia
Ordinace praktickeho lekare pro deti a dorost
Holice, U Kaplicky 1042, Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, U nemocnice380/III, Czechia
Universita di Firenze -Pediatria
Florence, , Italy
IRCCS Cà Granda
Milan, , Italy
Ospedale Maggiore della Carita
Novara, , Italy
Dip Pediatria AO Padova
Padua, , Italy
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela A Coruña, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
Valencia, , Spain
Complexo Hospitalario Xeral Cies
Vigo Pontevedra, , Spain
Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
Oxford, Headington, United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, , United Kingdom
St Georges Hospital
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2011-004931-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V72P12E2
Identifier Type: -
Identifier Source: org_study_id
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