A Study To Evaluate A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Healthy Subjects Aged 11-17 Years Received Either Menacwy-tt Vaccine (Nimenrix(Registered)) Or Mencevax Acwy(Registered).

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03189745
• Date of registration: 23/05/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Evaluate A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Healthy Subjects Aged 11-17 Years Received Either Menacwy-tt Vaccine (Nimenrix(Registered)) Or Mencevax Acwy(Registered).
• Scientific title: A PHASE IIIB, OPEN STUDY TO EVALUATE THE IMMUNOGENICITY, REACTOGENICITY AND SAFETY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER HEALTHY SUBJECTS AGED 11-17 YEARS RECEIVED EITHER MENACWY-TT VACCINE (NIMENRIX(REGISTERED)) OR MENCEVAX ACWY(REGISTERED).
• Date of first enrolment: August 1, 2017
• Target sample size: 229
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03189745
• Study type: Interventional
• Study design: Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Philippines

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who, in the opinion of the investigator, can and will comply, with the
requirements of the protocol (e.g. completion of the diary cards, return for follow-up
visits).

- Written informed consent obtained from the subject prior to performing any study
specific procedure.

- Healthy male or female subjects as established by medical history and history-directed
physical examination before entering into the study.

- Having completed the vaccination in study MenACWY-TT-036 (109069) as per protocol.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral
ovariectomy or post-menopause.

Please refer to the GLOSSARY OF TERMS for the definitions of menarche and post-menopause.

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

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

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within six months prior to the vaccine dose. For
corticosteroids, this will be 10 mg/day prednisone, or equivalent. Inhaled, topical,
and intra-articular steroids are allowed.

- Administration of a vaccine not foreseen by the study protocol within the period
starting 30 days before and ending 30 days after the study vaccine dose, with the
exception of a licensed inactivated influenza vaccine which can be administered at any
time during the study according to the local recommendations.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the study vaccination or planned administration during the booster
vaccination phase of the study (i.e. between Visit 1 and Visit 2).

- 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 (pharmaceutical product or device).

- Previous vaccination with meningococcal vaccine except the meningococcal vaccination
received in the MenACWY-TT-036 study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
or secondary), including human immunodeficiency virus infection, based on medical
history and physical examination (no laboratory testing required).

- Family history of congenital or hereditary immunodeficiency.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine, and history of serious allergic reaction (anaphylaxis) following the
administration of vaccine(s).

- Major congenital defects or serious chronic illness.

- History of any neurological disorders or seizures, including 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 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 (such as mild diarrhoea, mild upper respiratory
infection) without fever may be vaccinated at the discretion of the investigator.

- 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.

- 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.



Age minimum: 20 Years
Age maximum: 28 Years
Gender: All

Health Condition(s) or Problem(s) studied

Meningococcal ACWY Disease

Intervention(s)

Biological: MenACWY-TT

Primary Outcome(s)

Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination [Time Frame: 1 month after booster vaccination]

Secondary Outcome(s)

Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination [Time Frame: Before booster vaccination, 1 month after booster vaccination (Vac)]

Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination [Time Frame: 10 years after primary vaccination]

rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination [Time Frame: Before booster vaccination, 1 month after booster vaccination]

Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination [Time Frame: Before booster vaccination, 1 month after booster vaccination]

Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination [Time Frame: Within 31 days after booster vaccination (Day 0 to Day 30)]

Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination [Time Frame: 31 days after booster vaccination (Day 0 to Day 30)]

Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination [Time Frame: Before booster vaccination, 1 month after booster vaccination]

Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination [Time Frame: Within 4 days post booster vaccination (Day 0 to Day 3)]

Secondary ID(s)

116724

C0921005

MENACWY-TT-101

2013-001512-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03189745