Overview

This trial has been completed.

Condition infections, meningococcal
Treatments meningococcal group b vaccine, rmenb+omv nz, meningococcal acwy conjugate vaccine, menacwy
Phase phase 3
Sponsor GlaxoSmithKline
Start date June 2014
End date October 2016
Trial size 750 participants
Trial identifier NCT02106390, 2016-005117-44, 205240, V72_56

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose prevention
Masking no masking
Arm
(Experimental)
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
meningococcal group b vaccine, rmenb+omv nz Bexsero®
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.
meningococcal acwy conjugate vaccine, menacwy Menveo®
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.
(Active Comparator)
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
meningococcal group b vaccine, rmenb+omv nz Bexsero®
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.
(Active Comparator)
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
meningococcal acwy conjugate vaccine, menacwy Menveo®
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.

Primary Outcomes

Measure
hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY)
time frame: One month after the fourth vaccination
Between-group ratios of GMTs for rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ (serogroup B indicator strains), and rMenB+OMV NZ +MenACWY versus MenACWY (serogroups A, C, W-135 and Y
time frame: One month after the fourth vaccination

Secondary Outcomes

Measure
Evaluation of immune response of rMenB+OMV NZ by hSBA GMTs against each of the serogroup B indicator strains
time frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination
Evaluation of immune response of rMenB+OMV NZ by percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 against each of the serogroup B indicator strains
time frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination
Evaluation of immune response by hSBA GMTs against each of the serogroups A, C, W-135 and Y
time frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination
Evaluation of immune response by the percentage of subjects with hSBA ≥1:4 and subjects with hSBA ≥1:8 against each of the serogroups A, C, W-135 and Y
time frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination
Within-subject Geometric Mean Ratios (GMRs) against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y
time frame: One month after the fourth vaccination versus pre-fourth vaccination
Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y
time frame: One month after the fourth vaccination over pre-fourth vaccination
Frequencies and percentages of subjects with solicited local and systemic Adverse Events (AEs)
time frame: 7 days (including the day of vaccination) after Day 1, 61, 121, and 301 for all Vaccine Groups
Frequencies and percentages of subjects with any other (unsolicited) AEs, AEs leading to withdrawal and medically attended AEs
time frame: 7 days (including the day of vaccination) after at Day 1, 61, 121, and 301 for all Vaccine
Frequencies and percentages of subjects with SAEs, AEs leading to withdrawal and medically attended AEs
time frame: Throughout the study period (approximately 11 months)

Eligibility Criteria

All participants from 85 days up to 119 days old.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Additional Information

Official title A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.