No longer a GSK study

Study Description:

Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

GSK Study ID:

114858


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01340898


Has Results Available Below
EudraCT Number:

Not Available


Study Overview

Medical Conditions

Meningococcal infections

Product

GSK134612A

Collaborators

N/A


Date

January 2012 to October 2015

Type

Interventional

Phase

3


Gender

All

Age

6 weeks - 12 weeks

Accepts Healthy Volunteers

Yes


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Lebanon, Beirut 1107-2020Completed
Mexico, Durango, Durango 34000Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Number of subjects with serum bactericidal assay using rabbit complement (rSBA) against Neisseria meningitidis serogroups antibody titers greater than or equal to (≥) 1:8, one month post dose 3 for the Nimenrix 3+1 Group
    Timeframe: At Month 5 (one month post-dose 3)

Secondary Outcomes:

  • Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) 1:8 prior to and one month after the booster dose for the Nimenrix 3+1 Group
    Timeframe: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)

  • Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) 1:128, one month post-dose 3, prior to and one month after the booster dose for the Nimenrix 3+1 Group
    Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers one month post dose 3, prior to and one month after the booster dose for the Nimenrix 3+1 Group
    Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

  • Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the cut-off values for the Nimenrix 1+1 and Nimenrix Control Groups
    Timeframe: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers for Nimenrix 1+1 and Nimenrix Control Groups
    Timeframe: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

  • Number of subjects with booster responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 groups and with vaccine response in Nimenrix Control Group
    Timeframe: At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

  • Number of subjects with serum bactericidal assay using human complement against Neisseria meningitidis serogroups A, C, W-135, Y antibody titers greater than or equal to (≥) the cut-off values (one month post-primary for Nimenrix 3+1 and 1+1 Groups)
    Timeframe: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)

  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -randomized subset of 50% of subjects of all three groups
    Timeframe: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)

  • Number of participants with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y titers (≥) the cut-off value (pre- and post-booster for Nimenrix 3+1 and 1+1 Groups and pre- and post-vaccination for Nimenrix Control)
    Timeframe: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)

  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers (pre-booster for Nimenrix 3+1 and 1+1 Groups and pre-vaccination for Nimenrix Control, and post-booster for Nimenrix 3+1 and 1+1 Groups and post-vaccination for Nimenrix Control)
    Timeframe: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)

  • Number of subjects with booster responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 groups and with vaccine response in Nimenrix Control Group
    Timeframe: At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)

  • Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
    Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

  • Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.35 micrograms per milliliter (µg/mL)
    Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

  • Anti-pneumococcal antibody concentrations
    Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

  • Number of subjects with anti-diphtheria (anti-D) antibodies
    Timeframe: At Month 5 (one month post-dose 3)

  • Concentration of antibodies against diphtheria antigens (anti-D)
    Timeframe: At Month 5 (one month post-dose 3)

  • Concentration of antibodies against diphtheria antigens (anti-D)
    Timeframe: At Month 5 (one month post-dose 3)

  • Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens
    Timeframe: At Month 5 (one month post-dose 3)

  • Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies
    Timeframe: At Month 5 (one month post-dose 3)

  • Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens
    Timeframe: At Month 5 (one month post-dose 3)

  • Antibody titers for anti-polio type 1, 2 and 3 antibodies
    Timeframe: At Month 5 (one month post-dose 3)

  • Antibody titers for anti-polio type 1, 2 and 3 antibodies
    Timeframe: At Month 5 (one month post-dose 3)

  • Number of subjects with anti-tetanus (anti-T) antibodies
    Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

  • Concentration of antibodies against tetanus antigens (anti-T)
    Timeframe: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

  • Number of subjects with anti-tetanus (anti-T) antibodies
    Timeframe: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

  • Anti-PRP antibody concentrations (Geometric Mean Concentrations) in a randomized subset of 25% of the subjects
    Timeframe: At Month 5 (one month post-dose 3)

  • Number of subjects with solicited local symptoms (Primary Phase)
    Timeframe: Within 8 days (Day 0-7) post primary vaccination

  • Number of subjects with solicited local symptoms (Booster Phase)
    Timeframe: Within 8 days (Day 0-7) post booster vaccination

  • Number of subjects with solicited general symptoms (Primary Phase)
    Timeframe: Within 8 days (Day 0-7) post primary vaccination

  • Number of subjects with solicited general symptoms (Booster Phase)
    Timeframe: Within 8 days (Day 0-7) post booster vaccination

  • Number of subjects with unsolicited adverse events (AEs) (Primary Phase)
    Timeframe: Within 31 days (Day 0-30) post each primary vaccine dose

  • Number of subjects with unsolicited adverse events (AEs) (Booster phase)
    Timeframe: Within 31 days (Day 0-30) post booster vaccination

  • Number of subjects with new onset of chronic illnesses (NOCIs)
    Timeframe: From Day 0 to Month 19

  • Number of subjects with serious adverse events (SAEs)
    Timeframe: From Day 0 to Month 19

Arms:
  • 3

Interventions:

  • Biological/Vaccine: Meningococcal vaccine GSK 134612
  • Biological/Vaccine: SynflorixTM
  • Biological/Vaccine: Infanrix-IPV/HiberixTM

Keyword:

  • meningococcal conjugate vaccine, serogroups A,C, W-135 or Y, meningococcal diseases, Immunogenicity, Neisseria meningitidis, co-administration, routine vaccines
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 753