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

NCT ID: NCT01962207

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-06-30

Brief Summary

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.

Detailed Description

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).

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ACWY<2 Group

Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

ACWY≥2 Group

Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

MenCCRM Group

Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

MenPS Group

Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

Interventions

Meningococcal vaccine GSK134612

One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Espoo Vaccine Research Clinic

Espoo, , Finland

South Helsinki Vaccine Research Clinic

Helsinki, , Finland

Helsinki East Vaccine Research Clinic

Helsinki, , Finland

Jarvenpaa Vaccine Research Clinic

Järvenpää, , Finland

Tampereen yliopisto/ Oulun rokotetutkimusklinikka

Oulu, , Finland

Tampereen yliopisto/ Porin rokotetutkimusklinikka

Pori, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Tampereen yliopisto/ Turun rokotetutkimusklinikka

Turku, , Finland

Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka

Vantaa, , Finland

Countries

Finland

References

Vesikari T, Peyrani P, Webber C, Van Der Wielen M, Cheuvart B, De Schrevel N, Aris E, Cutler M, Li P, Perez JL. Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age. Hum Vaccin Immunother. 2020 Jun 2;16(6):1280-1291. doi: 10.1080/21645515.2020.1746110.

Reference Type: DERIVED

PMID: 32598244 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=MENACWY-TT-100&StudyName=A%20Phase%20Iiib%2C%20Open%2C%20Multi-center%20Study%20To%20Evaluate%20The%20Long-term%20Antibody%20Persistence%20At%206%2C%207%2C%208%2C%209%20And%2010%20Years%20After%20The%20Administration%20Of%20One%20Dose%20Of%20The%20Meningococcal%20Conjugate%20Vaccine%20Menacwy-tt%20Versus%20One%20Dose%20Of%20Meningitec%28registered%29%20Vaccine%20Or%20One%20Dose%20Of%20The%20Meningococcal%20Polysaccharide%20Vaccine%20Mencevax%28registered%29%20Acwy%2C%20And%20To%20Evaluate%20The%20Safety%20And%20Immunogenicity%20Of%20A%20Booster%20Dose%20Of%20Menacwy-tt%20Vaccine%20Administered%2010%20Years%20After%20Primary%20Vaccination%20Of%201-10%20Year%20Old%20Subjects%20With%20Menacwy-tt%2C%20Meningitec%28registered%29%20Or%20Mencevax%28registered%29%20Acwy.

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Other Identifiers

2013-001549-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C0921004

Identifier Type: OTHER

Identifier Source: secondary_id

200171

Identifier Type: OTHER

Identifier Source: secondary_id

MENACWY-TT-100

Identifier Type: -

Identifier Source: org_study_id