Last updated: 11/03/2018 19:45:29
Pfizer completed the acquisition of GSK's vaccine Nimenrix on 01-October-2015. The sponsorship for this clinical study was transferred from GSK to Pfizer as of 01-September-2016.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 GSK’s Clinical Study Register is no longer maintained for this study. The most up to date information is available on: www.clinicaltrials.gov. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Immunogenicity and safety study of 1 and 2 doses of GSK Biologicals’ meningococcal vaccine GSK134612 in toddlers, persistence up to 5 years after vaccination and co-administration with Pfizer's pneumococcal vaccine Prevenar 13™

GSK study ID
116892
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity and safety study of 1 and 2 doses of GSK Biologicals’ meningococcal vaccine GSK134612 in toddlers, persistence up to 5 years after vaccination and co-administration with Pfizer's pneumococcal vaccine Prevenar 13™
Trial description: The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals’ MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals’ MenACWY-TT with the booster dose of Pfizer’s Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Timeframe: 1 month after administration of 1 dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad groups (Month 1)

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Timeframe: At Year 1

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Timeframe: At Year 3

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Timeframe: At Year 5

Immunogenicity with respect to components of the study vaccines in terms of antibody concentration

Timeframe: 1 month after administration of Prevenar 13 (Month 1)

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Timeframe: 1 month after administration of 2 doses of MenACWY-TT in the ACWY2d group (Month 3)

Secondary outcomes:

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres

Timeframe: 1 month after administration of 1 dose of MenACWY-TT in a subset of subjects in the ACWY1d and ACWY2d groups (Month 1) and 2 doses in the ACWY2d group (Month 3)

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres

Timeframe: 1 month after administration of 1 dose of MenACWY-TT (Month 1)

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres

Timeframe: 1 month after administration of 1 dose of MenACWY-TT (Month 1)

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres

Timeframe: At Years 1, 3 and 5

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres

Timeframe: At Years 1, 3 and 5

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of antibody concentration

Timeframe: One month after administration of Prevenar 13 (Month 1)

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of OPA titres

Timeframe: One month after administration of Prevenar 13 (Month 1)

Occurrence of solicited local and general symptoms

Timeframe: Within 4 days (Day 0 – Day 3) after each study vaccination

Occurrence of unsolicited adverse events

Timeframe: Within 31 days (Day 0 – Day 30) after any study vaccination

Occurrence of serious adverse events (SAEs)

Timeframe: From Month 0 to Month 9

Occurrence of SAEs related to study vaccine administration

Timeframe: From the first receipt of study vaccine until study end (Year 5)

Occurrence of New Onset Chronic Illnesses (NOCIs)

Timeframe: From Month 0 to Month 9

Interventions:
  • Vaccine: Meningococcal vaccine GSK134612
  • Vaccine: Prevenar 13™
  • Enrollment:
    900
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A
    Collaborators
    Not applicable
    Study date(s)
    October 2013 to February 2020
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 14 Months
    Accepts healthy volunteers
    yes
    • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
    • Child in care.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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