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

NCT02106390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2018-08-22

Study results available
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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

Interventions

BIOLOGICAL

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.

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
85 Days
Max Age
119 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-05
Primary Completion
2016-10-14
Completion
2016-10-14

Countries

  • Argentina
  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02106390 on ClinicalTrials.gov