Last updated: 11/03/2018 10:23:58
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

GSK study ID
109377
Clinicaltrials.gov ID
EudraCT ID
Not applicable
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: Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
Trial description: The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals’ meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The protocol posting has been updated following a protocol amendment.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) antibody titers greater than or equal to the cut-off value

Timeframe: At Day 0 (PRE)

Number of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) antibody titers greater than or equal to the cut-off value

Timeframe: At Month 1

Secondary outcomes:

Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers greater than or equal to the cut-off value

Timeframe: At Day 0 (PRE) and Month 1

hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers

Timeframe: At Day 0 (PRE) and Month 1

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0–30) follow-up period after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 to Month 6

Number of subjects with new onset chronic illness(es) (NOCI)

Timeframe: From Day 0 to Month 6

Number of subjects reporting rash

Timeframe: From Day 0 to Month 6

Number of subjects reporting Adverse Events resulting in Emergency Room (ER) visits

Timeframe: From Day 0 to Month 6

Interventions:
Biological/vaccine: Meningococcal vaccine 134612
Biological/vaccine: Menactra®
Enrollment:
873
Observational study model:
Not applicable
Primary completion date:
2007-31-10
Time perspective:
Not applicable
Clinical publications:
Baxter R et al. (2011) Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age. Pediatric Infectious Disease Journal. 30(3):e41-e48.
Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
Medical condition
Infections, Meningococcal
Product
GSK134612A
Collaborators
Not applicable
Study date(s)
April 2007 to April 2008
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
10 - 25 years
Accepts healthy volunteers
Yes
  • Subjects whom the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Waianae, Hawaii, United States, 96792
Status
Study Complete
Location
GSK Investigational Site
Redwood City, California, United States, 94063
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Fairfield, California, United States, 94533
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95815
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96819
Status
Study Complete
Location
GSK Investigational Site
Waipio, Hawaii, United States, 96797
Status
Study Complete
Location
GSK Investigational Site
Daly City, California, United States, 94015
Status
Study Complete
Location
GSK Investigational Site
Vallejo, California, United States, 94589
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
No longer a GSK study
Actual primary completion date
2007-31-10
Actual study completion date
2008-11-04

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

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