A Phase IIIb, Open Label, Multi Center Extension Study of V72_28 to Assess Antibody Persistence, and the Safety and Tolerability of a Booster Dose After the Completion of the Vaccination Course in Study V72_28
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
851
2 countries
17
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
November 2015
Actual (reported)The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72\_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72\_28 study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2013
Actual (reported)July 10, 2013
Actual (reported)September 2015
Actual (reported)November 2015
Actual (reported)December 7, 2018
Actual (reported)Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
One month after booster vaccination (day 31)/24-36 months (Visit 1)
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study
From post primary visit in the parent study to visit 2 in this extension study
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study.
From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study
In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
Site 34, General Pediatric Practice Somorjai
Debrecen, Bajcsi Ut 32, 4025, Hungary
Site 35, Praxis Dr Eva Kovacs
Szeged, Csongradi Sgt 63, 6723, Hungary
Site 36, General Practice Dr Edit Oszlacs
Szeged, Debreceni Utca 10-14, 6723, Hungary
Site 37, Praxis Dr Julianna Kovacs
Bordány, Honved Utca 2, 6795, Hungary
Site 31, General Practice Dr Olga Fekete
Miskolc, Kando Kalman Utca 1, 3534, Hungary
Site 40, General Pediatric Practice Hacsek
Budapest, Poth Iren U 80, 1188, Hungary
Site 30, General Practice Dr Simko
Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.
Novartis Vaccines and Diagnostics
Novartis Vaccines
851 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2013
First Posted
July 10, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.
The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
At Day 1 in this study over one month after the completion of the vaccination course in the parent study
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.
The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.
At Day 1 in this study over visit 1 in the vaccination course in the parent study
In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Miskolc, Selyemret U. 1., 3527, Hungary
Site 33, General Pediatric Practice Ujhelyi
Nyíregyháza, Szent Istvan U 10, 4400, Hungary
Site 42, Praxis Dr Eszter Bari
Csongrád, Szentharomsag Ter 10, 6640, Hungary
Site 15
Almería, 04007, Spain
Site 16
Almería, 04120, Spain
Site 20
Barcelona, 08195, Spain
Site 17
Madrid, 28041, Spain
Site 18
Madrid, 28935, Spain
Site 13
Pontevedra, 36002, Spain
Site 10
Santiago de Compostela, 15706, Spain
Site 14
Seville, 41014, Spain
Primary Completion
September 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
November 30, 2021
Results First Posted
December 7, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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