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The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02230 Finland
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
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who,
in the opinion of the investigator, can and will comply with the requirements of the
protocol.

- A male or female who has received a primary vaccination with the MenACWY-TT,
Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (NCT00427908).

- 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 15 years of age, or written informed consent obtained from
the subject if the subject has achieved the 15th birthday. The subjects ≥15 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, hysterectomy or bilateral
ovariectomy.

- Male subjects able to father children and female subjects of childbearing potential
(including females who have had tubal ligation) and at risk of pregnancy 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 (for females only), and

- has agreed to continue adequate contraception during the entire treatment period
and for 2 months after completion of the vaccination.

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-027.

Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of
suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e.
MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be
followed for the persistence of MenA, MenW-135 and MenY.

- History of meningococcal disease due to serogroup A, C, W-135 or Y.

- Previous vaccination with meningococcal B vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
or secondary), including Human Immunodeficiency Virus (HIV) infection, based on
medical history and physical examination (no laboratory testing required).

- Family history of congenital or hereditary immunodeficiency.

- Major congenital defects or serious chronic illness.

- History of chronic alcohol consumption and/or drug abuse.

- Subjects who withdrew consent to be contacted for follow-up studies.

Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at
Month 126) for all subjects:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the booster dose of study vaccine, or planned
use during the follow-up period.

- 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 exception of a licensed inactivated influenza
vaccine.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the booster vaccine dose . Inhaled and topical steroids are
allowed.

- 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 .

- 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, tympanic, or ?38.0°C
for rectal route. The preferred route for recording temperature in this study
will be oral.

- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
infection) 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.

- Male subjects able to father children who are planning to discontinue contraceptive
precautions.

- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

NCT01962207
Pfizer
Recruiting
The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination

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The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
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 The Meningococcal Conjugate Vaccine Menacwy-tt Versus One Dose Of Meningitec(Registered) Vaccine Or One Dose Of The 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 1-10 Year Old Subjects With Menacwy-tt, Meningitec(Registered) Or Mencevax(Registered) Acwy.
The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec? or Mencevax? ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.

The study aims to evaluate the antibody persistence post primary vaccination with active control, safety and immunogenicity of a booster dose uncontrolled post primary vaccination during different phases:

Persistence phase: Long-term persistence 6, 7, 8, 9 and 10 years after primary vaccination with MenACWY-TT or Meningitec or Mencevax ACWY, in study MenACWY-TT-027.

Booster phase: One month post booster vaccination with MenACWY-TT vaccine ten years after primary vaccination.

The subjects in this study will be allocated to the same groups as in the vaccination study MenACWY-TT-027 (NCT00427908).

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections, Meningococcal
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
  • Experimental: ACWY<2 Group
    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Experimental: ACWY?2 Group
    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Experimental: MenCCRM Group
    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec.
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Experimental: MenPS Group
    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY.
    Intervention: Biological: Meningococcal vaccine GSK134612
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
259
July 4, 2018
February 20, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female who has received a primary vaccination with the MenACWY-TT, Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (NCT00427908).
  • 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 15 years of age, or written informed consent obtained from the subject if the subject has achieved the 15th birthday. The subjects ?15 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, hysterectomy or bilateral ovariectomy.
  • Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk of pregnancy 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 (for females only), and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.

Exclusion Criteria:

  • Child in care.
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MenACWY-TT-027.

Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e. MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be followed for the persistence of MenA, MenW-135 and MenY.

  • History of meningococcal disease due to serogroup A, C, W-135 or Y.
  • Previous vaccination with meningococcal B vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of chronic alcohol consumption and/or drug abuse.
  • Subjects who withdrew consent to be contacted for follow-up studies.

Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at Month 126) for all subjects:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
  • 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 exception of a licensed inactivated influenza vaccine.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . Inhaled and topical steroids are allowed.
  • 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 .
  • 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, tympanic, or ?38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) 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.
  • Male subjects able to father children who are planning to discontinue contraceptive precautions.
  • Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01962207
MENACWY-TT-100
2013-001549-15 ( EudraCT Number )
C0921004 ( Other Identifier: Alias Study Number )
200171 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...

URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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