NCT02106390

Brief Summary

The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

February 14, 2014

Results QC Date

October 6, 2017

Last Update Submit

June 14, 2018

Conditions

Infections, Meningococcal

Keywords

Central Nervous System DiseasesNervous System DiseasesMeningitis

Outcome Measures

Primary Outcomes (2)

  • Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains

    Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.

    At Day 331 (one month after the fourth vaccination)

  • hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y

    hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.

    At Day 331 (one month after the fourth vaccination)

Secondary Outcomes (31)

  • hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.

    At Day 1

  • hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.

    At Day 151 (one month after the third vaccination)

  • hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.

    At Day 301 (before the fourth vaccination)

  • hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.

    At Day 331 (one month after the fourth vaccination)

  • hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.

    At Day 1

  • +26 more secondary outcomes

Study Arms (3)

rMenB+ACWY

EXPERIMENTAL

Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.

Biological: Meningococcal group B Vaccine, rMenB+OMV NZBiological: Meningococcal ACWY Conjugate Vaccine, MenACWY

rMENB

ACTIVE COMPARATOR

Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.

Biological: Meningococcal group B Vaccine, rMenB+OMV NZ

MenACWY

ACTIVE COMPARATOR

Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.

Biological: Meningococcal ACWY Conjugate Vaccine, MenACWY

Interventions

Meningococcal group B Vaccine, rMenB+OMV NZBIOLOGICAL

4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.

Also known as: Bexsero®
rMENBrMenB+ACWY
Meningococcal ACWY Conjugate Vaccine, MenACWYBIOLOGICAL

4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.

Also known as: Menveo®
MenACWYrMenB+ACWY

Eligibility Criteria

Age85 Days - 119 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
  • Available for all the visits scheduled in the study.
  • In good health as determined by medical history, physical examination and clinical judgment of the investigator.

You may not qualify if:

  • History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
  • Previous known or suspected disease caused by N. meningitidis.
  • Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
  • History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
  • Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
  • Immune deficiency disorder, or known HIV infection.
  • Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
  • History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
  • History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
  • Child'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.
  • Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
  • Family members or household members of site research staff.
  • Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
  • History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Buenos Aires, C1425DEM, Argentina

Location

GSK Investigational Site

Buenos Aires, C1425EFD, Argentina

Location

GSK Investigational Site

Córdoba, X5000JRD, Argentina

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

GSK Investigational Site

Mexico City, 06400, Mexico

Location

GSK Investigational Site

Mexico City, 06760, Mexico

Location

GSK Investigational Site

Morelia, 58070, Mexico

Location

MeSH Terms

Conditions

Meningococcal InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitis

Interventions

4CMenB vaccineMenACWYMeningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

April 8, 2014

Study Start

June 5, 2014

Primary Completion

October 14, 2016

Study Completion

October 14, 2016

Last Updated

August 22, 2018

Results First Posted

August 22, 2018

Record last verified: 2018-01

Locations

ME(4)AR(3)