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

NCT01962207 | Completed Phase 3 Results

• 4 other identifiers: MENACWY-TT-1002013-001549-15C0921004200171
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 9

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.

Conditions

Infections, Meningococcal

Keywords

10 years Meningitec; Safety; booster response; Adolescents; Adults; Immunogenicity; Mencevax ACWY

Outcome Measures

Primary Outcomes (10)

• Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination

  Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).

  6 years after primary vaccination (Year 1 of study MENACWY-TT-100)

• Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

• Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

• Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

• Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  10 years after primary vaccination (Year 4 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

  Serogroups included MenA, MenC, MenW-135 and MenY.

  10 years after primary vaccination (Year 5 of study MENACWY-TT-100)

Secondary Outcomes (13)

• Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

  6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

• Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination

  6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

• Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

  1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

• Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

  1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

• Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination

  1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Study Arms (4)

ACWY<2 Group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612

ACWY≥2 Group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612

MenCCRM Group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612

MenPS Group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

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

ACWY<2 Group; ACWY≥2 Group; MenCCRM Group; MenPS Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

South Helsinki Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Tampereen yliopisto/ Oulun rokotetutkimusklinikka

Oulu, 90220, Finland

Location

Tampereen yliopisto/ Porin rokotetutkimusklinikka

Pori, 28100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Tampereen yliopisto/ Turun rokotetutkimusklinikka

Turku, 20520, Finland

Location

Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka

Vantaa, 01300, Finland

Location

Related Publications (1)

• 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.

  PMID: 32598244 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

FI (9)