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
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 |
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Pfizer Inc. | NCR |
Name | 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 | 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.
> 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:
- 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
Completed
- Philippines
Clinical Trial
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
None
Randomized
Open Label
Unspecified
Parallel
Prevention
Phase III