Clinical trial NCT01934140: 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: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Healthy
Adults
Safety
Neisseria meningitidis
Booster response
Immunogenicity
Adolescents
Serogroups A, C, W-135, and Y
long-term antibody persistence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 311
Sex: ALL
Minimum age (years): 17
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: After 6 years of primary vaccination
measure: 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
timeFrame: After 7 years of primary vaccination
measure: 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
timeFrame: After 8 years of primary vaccination
measure: 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
timeFrame: After 9 years of primary vaccination
measure: 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
timeFrame: After 10 years of primary vaccination
measure: Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
timeFrame: After 6 years of primary vaccination
measure: Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
timeFrame: After 7 years of primary vaccination
measure: Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
timeFrame: After 8 years of primary vaccination
measure: Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
timeFrame: After 9 years of primary vaccination
measure: Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
timeFrame: After 10 years of primary vaccination
Secondary outcomes:
measure: 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
timeFrame: 1 month after booster vaccination
measure: Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination
timeFrame: 1 month after booster vaccination
measure: Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
timeFrame: 1 month after booster vaccination
measure: 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
timeFrame: 1 month after booster vaccination
measure: Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination
timeFrame: 1 month after booster vaccination
measure: Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
timeFrame: Up to 4 days post booster vaccination
measure: Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination
timeFrame: Up to 31 days post booster vaccination
measure: Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
timeFrame: Up to 6 months post booster vaccination
measure: Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
timeFrame: Up to 6 months post booster vaccination
measure: Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
timeFrame: Up to 6 months post booster vaccination
measure: Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
timeFrame: Up to 6 months post booster vaccination
Other outcomes:
Locations:
city: Muntinlupa City
country: Philippines
facility: Research Institute for Tropical Medicine
state: Metro Manila
city: Manila
country: Philippines
facility: Philippine General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.