Submitted by: Yvette Lopez N/A Last Updated by: Yvette Lopez 2019-07-17 15:49:43


The long-term antibody persistence of MenACWY-TT vaccine (PF-06866681) versus Mencevax® ACWY in healthy adolescents and adults and booster response to MenACWY-TT vaccine administered at 10 years post primary vaccination.

PHRR150701-000744

C0921002 (MENACWY-TT-099)

2013-CT0112

A phase IIIb, open, multi-center study to evaluate the long-term antibody persistence at 6, 7, 8, 9 and 10 years after the administration of one dose of meningococcal conjugate vaccine MenACWY-TT versus one dose of meningococcal polysaccharide vaccine Mencevax® ACWY, and to evaluate the safety and immunogenicity of a booster dose of MenACWYTT vaccine administered 10 years after primary vaccination of 11-55 year old subjects with MenACWY-TT or Mencevax® ACWY 

In study MENACWY-TT-015, 500 healthy subjects between 11 and 55 years of age were randomized using a (3:1) ratio to receive either a single dose of MenACWY-TT vaccine or meningococcal PS vaccine. The subjects were followed up over five years post-vaccination.There is interest in the assessment of long term persistence of serological markers of protection following conjugate vaccination. The main purpose of this study is to evaluate the antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT
conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2014-04-29 120 2024-04-29 2018-10-15

Completed

Institution Classification Region LTO #
GlaxoSmithKline Philippines, Inc. Private Business NCR N/A
Pfizer Inc. Private Business NCR N/A
Institution Classification Region LTO #
ICON Clinical Research Services Inc. Private Business NCR CDRR-NCR-CRO-10
Institution Region
Pfizer Inc. NCR
Name E-Mail Institution and Institution Address
Yvette Martha Lopez Yvette.Lopez@iconplc.com ICON Clinical Research Services Philippines Inc. Salcedo Towers, 169 H.V. Dela Costa St., Salcedo Village, Makati City
Name E-Mail Institution and Institution Address
Irish Sales irish.sales@iconplc.com ICON Clinical Research Services Philippines Inc. Salcedo Towers, 169 H.V. Dela Costa St., Salcedo Village, Makati City
Name Expertise Affiliation
Charissa Fay C. Borja-Tabora, MD Pediatrics Infectious Disease Research Institute for Tropical Medicine
Ma. Cecilia Montalban, MD Infectious Disease Philippine General Hospital
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board

Active immunization against invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y in healthy subjects aged 11 to 55 years of age.

Long-term persistence phase: Six, seven, eight, nine and ten years after primary vaccination with MenACWY-TT or Mencevax ACWY, in Study MENACWY-TT-015

> To evaluate the long-term persistence of the serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to Mencevax ACWY when administered to individuals 11-55 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titers >/=1:8, >/=1:128 and Geometric mean titres (GMTs) as measured by a serum bactericidal assay using rabbit complement (rSBA).

Secondary One month post-booster vaccination with MenACWY-TT vaccine ten years after primary vaccination:

> To evaluate the immunogenicity of a booster vaccination of MenACWY-TT with respect to the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-
135, and rSBA-MenY antibody titers >/= 1:8, >/=1:128 and GMTs.

> To evaluate the immunogenicity of booster vaccination in terms of the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
*rSBA vaccine responses for serogroups A, C, W-135 and Y are defined as:
       - For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): rSBA antibody titers >/= 1:32 one month after vaccination, and
       - 
For initially seropositive subjects (pre-vaccination titer  >/=  1:8): rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination. 

Pre-booster and one month post-booster vaccination with MenACWY-TT vaccine ten years after primary vaccination
> To evaluate the percentage of subjects with anti-TT concentrations >/= 0.1 IU/mL, >/= 1.0 IU/mL and GMCs.

Secondary safety objectives:
 > To evaluate the safety and reactogenicity of a booster vaccination dose of MenACWY-TT in terms of solicited symptoms, unsolicited symptoms, Serious Adverse Events (SAEs) and New Onset of Chronic Illnesses (NOCIs) (e.g., autoimmune disorders,)


Completed

  • Philippines

Clinical Trial

C0921002 (MENACWY-TT-099)

Unspecified

2013-09-25

0000-00-00

399

400

Unspecified

29 Apr 2014

All subjects must satisfy the following criteria at study entry to the persistence phase:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and 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 17 and 66 years of age at the time of entry into the present study.
  • Has completed the vaccination phase of the vaccination study MENACWY-TT-015.
  • In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
  • Healthy subjects as established by medical history and history-directed physical examination before entering into the study.

All subjects must satisfy the following additional criteria prior to entry of the booster phase:

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, bilateral,ovariectomy or post-menopause.
  • Male subjects able to father children and female subjects of childbearing potential (including female subjects who have had tubal ligation) may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Child in care.
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
  • History of meningococcal disease due to serogroup A, C, W-135 or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
  • Major congenital defects or serious chronic illness.
  • Family history of congenital or hereditary immunodeficiency.
  • History of chronic alcohol consumption and/or drug abuse.

Additional exclusion criteria for booster phase at Month 120 study entry (to be checked at Month 120) for all subjects

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. Inhaled topical and intra-articular steroids are allowed.
  • Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
  • 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 vaccine/product.
  • Previous vaccination with tetanus toxoids within the last month.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of vaccination.

    • Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Interventional

Biological: Meningococcal vaccine GSK134612

The conjugate vaccine (MenACWY-TT) to be used in this study has been developed and
manufactured by GSK Biologicals. MenACWY-TT was acquired by Pfizer on 01 October 2015.
1 dose administered intramuscularly in the non-dominant deltoid region.

None

Randomized

Open Label

Unspecified

Parallel

Prevention

Phase III

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