NCT01340898

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
753

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

January 27, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2019

Completed
Last Updated

August 6, 2019

Status Verified

June 1, 2019

Enrollment Period

2.5 years

First QC Date

April 14, 2011

Results QC Date

September 11, 2017

Last Update Submit

June 11, 2019

Conditions

Meningococcal Infection

Keywords

meningococcal conjugate vaccineserogroups A,C, W-135 or Ymeningococcal diseasesImmunogenicityNeisseria meningitidisco-administrationroutine vaccines

Outcome Measures

Primary Outcomes (1)

  • 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

    The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.

    At Month 5 (one month post-dose 3)

Secondary Outcomes (33)

  • 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

    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

    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

    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

    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

    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)

  • +28 more secondary outcomes

Study Arms (3)

Nimenrix 3+1 Group

EXPERIMENTAL

Subjects, male and female, received 4 doses of Nimenrix™ vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Biological: Meningococcal vaccine GSK 134612Biological: SynflorixTMBiological: Infanrix-IPV/HiberixTM

Nimenrix 1+1 Group

EXPERIMENTAL

Subjects, male and female, received 2 doses of Nimenrix™ vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Biological: Meningococcal vaccine GSK 134612Biological: SynflorixTMBiological: Infanrix-IPV/HiberixTM

Nimenrix Control Group

EXPERIMENTAL

Subjects, male and female, received 1 dose of Nimenrix™ at 15-18 months of age and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Biological: Meningococcal vaccine GSK 134612Biological: SynflorixTMBiological: Infanrix-IPV/HiberixTM

Interventions

Meningococcal vaccine GSK 134612BIOLOGICAL

Intramuscular injection

Nimenrix 1+1 GroupNimenrix 3+1 GroupNimenrix Control Group
SynflorixTMBIOLOGICAL

Intramuscular injection

Nimenrix 1+1 GroupNimenrix 3+1 GroupNimenrix Control Group
Infanrix-IPV/HiberixTMBIOLOGICAL

Intramuscular injection

Nimenrix 1+1 GroupNimenrix 3+1 GroupNimenrix Control Group

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
  • A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

You may not qualify if:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Extended administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
  • History of receipt of meningococcal vaccine.
  • Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
  • History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of th

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Beirut, 1107-2020, Lebanon

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

Related Publications (1)

  • Dbaibo G, Tinoco Favila JC, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study. Vaccine. 2018 Jun 27;36(28):4102-4111. doi: 10.1016/j.vaccine.2018.05.046. Epub 2018 May 18.

    PMID: 29784470DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 25, 2011

Study Start

January 27, 2012

Primary Completion

August 4, 2014

Study Completion

October 19, 2015

Last Updated

August 6, 2019

Results First Posted

August 6, 2019

Record last verified: 2019-06

Locations

LE(1)ME(1)