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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).

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ClinicalTrials.gov Identifier: NCT03189745
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE June 16, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date April 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
Percentage of subjects with a booster response after vaccination with MenACWY-TT. [ Time Frame: 1 MONTH ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03189745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
  • Immunogenicity to the components of the investigational vaccine MenACWY-TT [ Time Frame: Before vaccination and 1 month after vaccination ]
  • Occurrence of solicited local symptoms after MenACWY-TT vaccination. [ Time Frame: From vaccination up to 4 days after vaccination ]
  • Occurrence of unsolicited Adverse Events (AE), after MenACWY-TT vaccination. [ Time Frame: From vaccination up to 31 days after vaccination ]
  • Occurrence of all Serious Adverse Events (SAEs) after MenACWY-TT vaccination. [ Time Frame: From obtaining informed consent up to 31 days after vaccination ]
  • Occurrence of SAEs, related to primary vaccination and any event related to lack of vaccine efficacy after MenACWY-TT vaccination. [ Time Frame: from the subject's last visit in the primary study MenACWY-TT-036 (10 years) or in the persistence study MenACWY-TT-043 (5 years) until entry in study C0921005 ]
  • Occurrence of solicited general symptoms after MenACWY-TT vaccination [ Time Frame: From vaccination up to 4 days after vaccination ]
  • Occurrence of all incidences of Guillain-Barre syndrome (GBS) [ Time Frame: From vaccination up to 31 days after vaccination ]
  • Occurrence of all New Onset of Chronic Illnesses (NOCI) [ Time Frame: From day of vaccination up to 31 days after vaccination ]
  • Occurrence of any event related to lack of vaccine efficacy after MenACWY-TT vaccination. [ Time Frame: From the subject's last visit in the primary study MenACWY-TT-036 until entry in study C0921005; 10 years ]
  • Occurrence of any event related to lack of vaccine efficacy after MenACWY-TT vaccination. [ Time Frame: From the subject's last visit in the persistence study MenACWY-TT-043 until entry in study C0921005; 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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).
Official Title  ICMJE 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).
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal ACWY Disease
Intervention  ICMJE Biological: MenACWY-TT
Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY
Study Arms  ICMJE Experimental: MenACWY-TT Booster
10 year booster dose of MenACWY
Intervention: Biological: MenACWY-TT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2018)
229
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2017)
200
Actual Study Completion Date  ICMJE April 11, 2018
Actual Primary Completion Date April 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 28 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03189745
Other Study ID Numbers  ICMJE MENACWY-TT-101
C0921005 ( Other Identifier: Alias Study Number )
2013-001512-29 ( EudraCT Number )
116724 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP