Clinical trial NCT02106390: Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Official title: A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Central Nervous System Diseases
Nervous System Diseases
Meningitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 750
Sex: ALL
Minimum age (years): 85
Maximum age (years): 119
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Available for all the visits scheduled in the study.
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

1. History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
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. 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.
6. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
7. History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
8. History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
9. 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.
10. Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
11. Family members or household members of site research staff.
12. 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).
13. 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.

Primary outcomes:
measure: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 331 (one month after the fourth vaccination)
Secondary outcomes:
measure: hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
timeFrame: At Day 1
measure: hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
timeFrame: At Day 151 (one month after the third vaccination)
measure: hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
timeFrame: At Day 301 (before the fourth vaccination)
measure: hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
timeFrame: At Day 1
measure: hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 151 (one month after the third vaccination)
measure: hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
timeFrame: At Day 301 (before the fourth vaccination)
measure: hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 1
measure: Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 151 (one month after the third vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
timeFrame: At Day 301 (before the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
timeFrame: At Day 331 (One month after the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 1
measure: Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 151 (one month after the third vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 301 (before the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 1
measure: Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 151 (one month after the third vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 301 (before the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 331 (one month after fourth vaccination)
measure: Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 1
measure: Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 151 (one month before the third vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 301 (before the fourth vaccination)
measure: Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
timeFrame: At Day 331 (one month after the fourth vaccination)
measure: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
measure: Number of Subjects With Unsolicited Adverse Events
timeFrame: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
measure: Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
timeFrame: Throughout the whole study period (from Day 1 upto Day 331)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Morelia
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: