Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03571607
Previous Study | Return to List | Next Study

A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03571607
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: 13-valent pneumococcal conjugate vaccine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO PNEUMOCOCCAL VACCINES
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 13-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Name: 13vPnC




Primary Outcome Measures :
  1. Percentage of subjects reporting local reactions within 7days for subjects aged 6 to 17 years or 14 days for subjects aged 18 to 64 years after vaccination (redness, swelling, and pain at injection site). [ Time Frame: Day 1-7 for subjects aged 6 to 17 years or Day 1-14 for subjects aged 18 to 64 years ]
  2. Percentage of subjects reporting systemic events within 7days for subjects aged 6 to 17 years or 14 days for subjects aged 18 to 64 years after vaccination (fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain). [ Time Frame: Day 1-7 for subjects aged 6 to 17 years or Day 1-14 for subjects aged 18 to 64 years ]
  3. Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  4. Percentage of subjects reporting serious adverse events (SAEs) within 1 month after vaccination. [ Time Frame: 1 month after vaccination ]

Secondary Outcome Measures :
  1. Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  2. Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  3. Pneumococcal serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) measured 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  4. Pneumococcal serotype-specific IgG geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination. [ Time Frame: 1 month after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese males and females aged 6 to <65 years at enrollment.
  • Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
  • End-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal disease with or without dialysis.
  • Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months before investigational product administration or history of HSCT, or potential for solid organ transplant or HSCT during study participation.
  • Receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-B-cell antibodies within 6 months before investigational product administration through completion of study participation.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Documented S pneumoniae infection within the past 5 years before investigational product administration.

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): NCT03571607


Locations
Layout table for location information
Japan
Daido Clinic
Nagoya, Aichi, Japan, 457-8511
Nippon Kokan Fukuyama Hospital
Fukuyama, Hiroshima, Japan, 721-0927
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan, 721-8511
Kawasaki Municipal Hospital
Kawasaki, Kanagawa, Japan, 210-0013
Nagano Prefectural Shinshu Medical Center
Suzaka, Nagano, Japan, 382-8577
Medical Co.LTA PS Clinic
Fukuoka, Japan, 812-0025
Fukuoka Children's Hospital
Fukuoka, Japan, 813-0017
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan, 860-0008
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03571607     History of Changes
Other Study ID Numbers: B1851172
2018-003054-24 ( EudraCT Number )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs