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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

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

Condition or disease Intervention/treatment Phase
Meningococcal ACWY Disease Biological: MenACWY-TT Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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).
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 11, 2018

Arm Intervention/treatment
Experimental: MenACWY-TT Booster
10 year booster dose of MenACWY
Biological: MenACWY-TT
Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY




Primary Outcome Measures :
  1. Percentage of subjects with a booster response after vaccination with MenACWY-TT. [ Time Frame: 1 MONTH ]

Secondary Outcome Measures :
  1. Immunogenicity to the components of the investigational vaccine MenACWY-TT [ Time Frame: Before vaccination and 1 month after vaccination ]
  2. Occurrence of solicited local symptoms after MenACWY-TT vaccination. [ Time Frame: From vaccination up to 4 days after vaccination ]
  3. Occurrence of unsolicited Adverse Events (AE), after MenACWY-TT vaccination. [ Time Frame: From vaccination up to 31 days after vaccination ]
  4. Occurrence of all Serious Adverse Events (SAEs) after MenACWY-TT vaccination. [ Time Frame: From obtaining informed consent up to 31 days after vaccination ]
  5. 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 ]
  6. Occurrence of solicited general symptoms after MenACWY-TT vaccination [ Time Frame: From vaccination up to 4 days after vaccination ]
  7. Occurrence of all incidences of Guillain-Barre syndrome (GBS) [ Time Frame: From vaccination up to 31 days after vaccination ]
  8. Occurrence of all New Onset of Chronic Illnesses (NOCI) [ Time Frame: From day of vaccination up to 31 days after vaccination ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189745


Locations
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Philippines
Research Institute for Tropical Medicine
Muntinlupa City, Metro Manila, Philippines, 1781
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03189745     History of Changes
Other Study ID Numbers: MENACWY-TT-101
C0921005 ( Other Identifier: Alias Study Number )
2013-001512-29 ( EudraCT Number )
116724 ( Other Identifier: Alias Study Number )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs