Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine

NCT01027351 | Completed Phase 2 Results

• 2 other identifiers: V72P6E1EUDRACT 2009-013054-33
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.

Conditions

Meningococcal Disease

Keywords

Children; Pre-school; Meningococcal disease; Prevention; Vaccination

Outcome Measures

Primary Outcomes (3)

• Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.

  Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.

  28 months after last vaccination; Baseline for Naïve

• Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.

  The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).

  28 months after last vaccination; baseline for naïve

• Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.

  The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.

  Day 1-7 after booster vaccination

Secondary Outcomes (20)

• Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.

  28 months after vaccination; Baseline for Naïve

• Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.

  28 months after vaccination; baseline for naïve

• Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.

  1 month post- booster/ dose 1 for Naïve

• Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.

  1 month post- booster/ dose 1 for Naïve

• Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.

  1 month post - booster/ -dose 1 for Naïve

Study Arms (6)

5rMenB

EXPERIMENTAL

Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)

5rMenB+OMV NZ

EXPERIMENTAL

Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

3rMenB

EXPERIMENTAL

Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine without OMV (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)

3rMenB+OMV NZ

EXPERIMENTAL

Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

Naive_4042

EXPERIMENTAL

Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 40 and 42 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

Naive_6062

EXPERIMENTAL

Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 60 and 62 months of age in the present study.

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.

Interventions

Meningococcal (group B) multicomponent recombinant adsorbed vaccine. BIOLOGICAL

Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.

3rMenB+OMV NZ; 5rMenB+OMV NZ; Naive_4042; Naive_6062

Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) BIOLOGICAL

Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).

3rMenB; 5rMenB

Eligibility Criteria

• Age: 40 Months - 62 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)
• Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

You may not qualify if:

• Previous ascertained or suspected disease caused by N. meningitidis
• History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
• Any serious chronic or progressive disease
• Known or suspected impairment/alteration of the immune system
• Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

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

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (2)

• McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Yu LM, Toneatto D, D'Agostino D, Dull PM, Pollard AJ. Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months. CMAJ. 2015 Apr 21;187(7):E215-E223. doi: 10.1503/cmaj.141200. Epub 2015 Mar 23.

  PMID: 25802309 DERIVED

• Snape MD, Saroey P, John TM, Robinson H, Kelly S, Gossger N, Yu LM, Wang H, Toneatto D, Dull PM, Pollard AJ. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ. 2013 Oct 15;185(15):E715-24. doi: 10.1503/cmaj.130257. Epub 2013 Sep 23.

  PMID: 24062178 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

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

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2012
• Last Updated: October 9, 2018
• Results First Posted: May 6, 2014

Record last verified: 2018-09

Locations

GB (1)