Meningococcal ACWY Disease Clinical Trial
Official 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).
| Verified date | September 2020 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will 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) or Mencevax ACWY
| Status | Completed |
| Enrollment | 229 |
| Est. completion date | April 11, 2018 |
| Est. primary completion date | April 11, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 28 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Research Institute for Tropical Medicine | Muntinlupa City | Metro Manila |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 10 years after primary vaccination | |
| Other | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. | 10 years after primary vaccination | |
| Primary | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster 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). The rSBA titer levels greater than or equal to (>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer >=1:8. Data reported below is including both seropositive and seronegative participants. | 1 month after booster vaccination | |
| Secondary | 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 | Serogroups included MenA, MenC, MenW-135 and MenY. | Before booster vaccination, 1 month after booster vaccination (Vac) | |
| Secondary | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units. | Before booster vaccination, 1 month after booster vaccination | |
| Secondary | 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 | Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized. | Before booster vaccination, 1 month after booster vaccination | |
| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. The GMCs calculations was performed by taking the anti-log of the mean of the log concentration transformations. Antibody (Anti-TT) concentrations below the cut-off value (0.1 IU/mL) of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation. | Before booster vaccination, 1 month after booster vaccination | |
| Secondary | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Solicited local reactions included pain, redness and swelling. Pain graded as: (0= none, 1= mild, not interfered/prevented normal activity, 2= moderate, painful when limb moved/interfered with normal activity, 3= severe, significant pain at rest/ prevented normal activity). Redness and swelling scored as:0= None, 1= 0 to less than or equal to (<=) 20 millimeter (mm), 2= greater than (>) 20 to <=50 mm, 3=>50 mm. Solicited general reactions: headache, fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea /abdominal pain) graded as (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe / prevented normal activity). Fever categorized as: 0= less than (<) 37.5 degree Celsius (C), 1= >=37.5 to <=38.5 degree C, 2= >38.5 to <=39.5 degree C, and 3= >39.5 degree C. | Within 4 days post booster vaccination (Day 0 to Day 3) | |
| Secondary | Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. And any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | 31 days after booster vaccination (Day 0 to Day 30) | |
| Secondary | 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 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. GBS is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. All occurrences of GBS has to be reported as an SAE. New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. | Within 31 days after booster vaccination (Day 0 to Day 30) | |
| Secondary | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Occurrence of SAEs related to primary vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the participant's last visit in the primary study 109069 (NCT00464815) or in persistence study 112148 (NCT00974363); extension study: 109069 (NCT00464815) at Year 2, 3, 4, 5 after primary vaccination until entry in study MenACWYTT-101, which is extension of study 109069 (NCT00464815), 10 years post primary vaccination. | 10 years after primary vaccination |