Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

NCT ID: NCT02106390

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-05
• Study Completion Date: 2016-10-14

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

rMenB+ACWY

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

Group Type: EXPERIMENTAL

Meningococcal group B Vaccine, rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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.

rMENB

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

Group Type: ACTIVE_COMPARATOR

Meningococcal group B Vaccine, rMenB+OMV NZ

Intervention Type: BIOLOGICAL

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.

MenACWY

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

Group Type: ACTIVE_COMPARATOR

Meningococcal ACWY Conjugate Vaccine, MenACWY

Intervention Type: BIOLOGICAL

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.

Interventions

Meningococcal group B Vaccine, rMenB+OMV NZ

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.

Intervention Type: BIOLOGICAL

Meningococcal ACWY Conjugate Vaccine, MenACWY

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Bexsero®; Menveo®

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.

• Minimum Eligible Age: 85 Days
• Maximum Eligible Age: 119 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Córdoba, , Argentina

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Morelia, , Mexico

Countries

Argentina; Mexico

Other Identifiers

V72_56

Identifier Type: OTHER

Identifier Source: secondary_id

2016-005117-44

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205240

Identifier Type: -

Identifier Source: org_study_id