Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

NCT ID: NCT01894919

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-11-30

Brief Summary

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.

Conditions

Meningoccocal Disease; Meningococcal Meningitis

Keywords

Meningococcal B disease,; Antibody persistence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2H3H511_V

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.

Group Type: EXPERIMENTAL

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

2H3H511_NV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

3H5_11_V

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.

Group Type: EXPERIMENTAL

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

3H5_11_NV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

68_11_V

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.

Group Type: EXPERIMENTAL

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

68_11_NV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

02_2_5_V

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.

Group Type: EXPERIMENTAL

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

02_2_5_NV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

02_6_10_V

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.

Group Type: EXPERIMENTAL

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

02_6_10_NV

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

NAIVE 123

Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Group Type: EXPERIMENTAL

Bexsero® vaccine (2 doses 1 month apart)

Intervention Type: BIOLOGICAL

NAIVE_4A

Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Group Type: EXPERIMENTAL

Bexsero® vaccine (2 doses 1 month apart)

Intervention Type: BIOLOGICAL

NAIVE_4B

Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Group Type: EXPERIMENTAL

Bexsero® vaccine (2 doses 1 month apart)

Intervention Type: BIOLOGICAL

Interventions

Bexsero® vaccine (1 dose at study month zero)

Intervention Type: BIOLOGICAL

Bexsero® vaccine (2 doses 1 month apart)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

For naïve subjects newly enrolled:

1. Healthy infants and children according to the following age groups:

1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age),

2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age).

3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age).

2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;

3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;

4. in good health as determined by medical history, physical examination, clinical judgment of the investigator.

For Subjects who participated in the V72_28 study (Follow-on Subjects):

1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;

2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;

3. in good health as determined by medical history, physical examination, clinical judgment of the investigator

4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1

Exclusion Criteria

For naïve subjects newly enrolled:

1. History of any serogroup B meningococcal vaccine administration;

2. Previous known or suspected disease caused by N. meningitidis;

3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;

4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;

5. Pregnancy or nursing (breastfeeding) mothers;

6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;

7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

• Receipt of any chronic immunosuppressive therapy
• Receipt of any chronic immunostimulants
• Immune deficiency disorder, or known HIV infection

8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).

9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.

10. Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.

11. Intent to participate in another clinical study during this study.

12. Family members and household members of study staff;

13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.

14. Any significant chronic infection.

15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

For Subjects who participated in the V72_28 study (Follow-on Subjects):

• Minimum Eligible Age: 35 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Site 34, General Pediatric Practice Somorjai

Debrecen, Bajcsi Ut 32, Hungary

Site 35, Praxis Dr Eva Kovacs

Szeged, Csongradi Sgt 63, Hungary

Site 36, General Practice Dr Edit Oszlacs

Szeged, Debreceni Utca 10-14, Hungary

Site 37, Praxis Dr Julianna Kovacs

Bordány, Honved Utca 2, Hungary

Site 31, General Practice Dr Olga Fekete

Miskolc, Kando Kalman Utca 1, Hungary

Site 40, General Pediatric Practice Hacsek

Budapest, Poth Iren U 80, Hungary

Site 30, General Practice Dr Simko

Miskolc, Selyemret U. 1., Hungary

Site 33, General Pediatric Practice Ujhelyi

Nyíregyháza, Szent Istvan U 10, Hungary

Site 42, Praxis Dr Eszter Bari

Csongrád, Szentharomsag Ter 10, Hungary

Site 15

Almería, , Spain

Site 16

Almería, , Spain

Site 20

Barcelona, , Spain

Site 17

Madrid, , Spain

Site 18

Madrid, , Spain

Site 13

Pontevedra, , Spain

Site 10

Santiago de Compostela, , Spain

Site 14

Seville, , Spain

Countries

Hungary; Spain

References

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.

Reference Type: DERIVED

PMID: 29253560 (View on PubMed)

Other Identifiers

2012-000657-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V72_28E1

Identifier Type: -

Identifier Source: org_study_id