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

NCT01934140 | Completed Phase 3 Results

• 4 other identifiers: MENACWY-TT-0992012-005639-10C0921002116725
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 2

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.

Conditions

Infections, Meningococcal

Keywords

Healthy; Adults; Safety; Neisseria meningitidis; Booster response; Immunogenicity; Adolescents; Serogroups A, C, W-135, and Y; long-term antibody persistence

Outcome Measures

Primary Outcomes (10)

• Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 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).

  After 6 years of primary vaccination

• 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.

  After 7 years of primary vaccination

• 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.

  After 8 years of primary vaccination

• 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.

  After 9 years of primary vaccination

• 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.

  After 10 years of primary vaccination

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

  Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.

  After 6 years of primary vaccination

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

  Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

  After 7 years of primary vaccination

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

  Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

  After 8 years of primary vaccination

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

  Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

  After 9 years of primary vaccination

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

  Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

  After 10 years of primary vaccination

Secondary Outcomes (11)

• 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

• Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination

  1 month after booster vaccination

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

  1 month after booster vaccination

• Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination

  1 month after booster vaccination

• Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination

  1 month after booster vaccination

Study Arms (2)

ACWY-TT group

EXPERIMENTAL

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.

Biological: Meningococcal vaccine GSK134612

MenPS group

ACTIVE COMPARATOR

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.

Biological: Meningococcal vaccine GSK134612

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

1 dose administered intramuscularly in the non-dominant deltoid region.

ACWY-TT group; MenPS group

Eligibility Criteria

• Age: 17 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Research Institute for Tropical Medicine

Muntinlupa City, National Capital Region, 1781, Philippines

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

Related Publications (1)

• Borja-Tabora CFC, Peyrani P, Webber C, Van der Wielen M, Cheuvart B, De Schrevel N, Bianco V, Aris E, Cutler M, Li P, Perez JL. A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years. BMC Infect Dis. 2020 Jun 18;20(1):426. doi: 10.1186/s12879-020-05104-5.

  PMID: 32552685 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

Limitations and Caveats

Enrollment for this study (MENACWY-TT-99) started at Year 6. However, Study visit for Year 6 was not done because approval was not obtained from the authorities until after the end of the Year 6. Hence, no planned activities were done for Year 6.

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: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 4, 2013
• Study Start: April 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

PH (2)