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Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

Last updated on November 7, 2019

FOR MORE INFORMATION
Study Location
Research Institute for Tropical Medicine
Muntinlupa City, Metro Manila, 1781 Philippines
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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, ovariectomy or post-menopause.

- Female subjects of childbearing potential 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 and topical 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 enrollment.

- 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.

NCT01934140
Pfizer
Recruiting
Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

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Descriptive Information
Brief Title  ICMJE Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination
Official Title  ICMJE 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(REGISTERED) ACWY, AND TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER PRIMARY VACCINATION OF 11-55 YEAR OLD SUBJECTS WITH MENACWY-TT OR MENCEVAX (REGISTERED) ACWY.
Brief Summary

The purpose of this study is to evaluate the long-term 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.

All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infections, Meningococcal
Intervention  ICMJE Biological: Meningococcal vaccine GSK134612
1 dose administered intramuscularly in the non-dominant deltoid region.
Study Arms  ICMJE
  • Experimental: ACWY-TT group
    All subjects vaccinated with MenACWY-TT in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a booster dose of MenACWY-TT in this study.
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Active Comparator: MenPS group
    All subjects vaccinated with Mencevax ACWY in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a dose of MenACWY-TT in this study.
    Intervention: Biological: Meningococcal vaccine GSK134612
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
311
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2013)
400
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion DateFebruary 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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, ovariectomy or post-menopause.
  • Female subjects of childbearing potential 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 and topical 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 enrollment.

    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 17 Years to 66 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01934140
Other Study ID Numbers  ICMJE MENACWY-TT-099
2012-005639-10 ( EudraCT Number )
C0921002 ( Other Identifier: Alias Study Number )
116725 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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