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

NCT01026974 | Completed Phase 2 Results

• 2 other identifiers: V72P9E1EUDRACT 2009-013075-21
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose 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 Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.

  The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.

  28 months after primary vaccination; Baseline for Naïve

• Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.

  The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).

  28 months after primary vaccination; Baseline for Naïve

• Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.

  The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.

  Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]

Secondary Outcomes (18)

• Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

  1 month post booster /1 month post dose 1 for Naïve

• Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age

  1 month post-booster/ 1 month post-dose 1 for Naïve

• Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

  1 month post booster / 1 month post dose 1 for Naïve

• Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine

  20 months post booster/ Baseline for Naïve

• Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine

  20 months post booster/ Baseline for Naïve

Study Arms (4)

4rMenB

EXPERIMENTAL

Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB vaccine at 40 months of age in the present study.

Biological: rMenB

4rMenB+OMV NZ

EXPERIMENTAL

Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.

Biological: rMenB+OMV NZ

Naive_4042

EXPERIMENTAL

Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Biological: rMenB+OMV NZ

Naive_6062

EXPERIMENTAL

Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Biological: rMenB+OMV NZ

Interventions

rMenB BIOLOGICAL

4rMenB

rMenB+OMV NZ BIOLOGICAL

4rMenB+OMV NZ; Naive_4042; Naive_6062

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 V72P9 (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, Center for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (2)

• McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.

  PMID: 24722351 BACKGROUND

• Snape MD, Philip J, John TM, Robinson H, Kelly S, Gossger N, Yu LM, Kittel C, Toneatto D, Dull PM, Pollard AJ. Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial. Pediatr Infect Dis J. 2013 Oct;32(10):1116-21. doi: 10.1097/INF.0b013e31829cfff2.

  PMID: 23958808 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: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2012
• Last Updated: October 1, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-09

Locations

GB (1)