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A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01646398
First received: May 10, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.


Condition Intervention Phase
Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).

  • Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.


Secondary Outcome Measures:
  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).


Other Outcome Measures:
  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).

  • Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ] [ Designated as safety issue: Yes ]
    Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.


Enrollment: 764
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: >= 65-year age group-13vPnC 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
Active Comparator: >= 65-year age group-23vPS Biological: 23-valent pneumococcal polysaccharide vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Name: 23VPS

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
  2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria:

  1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
  2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
  3. Documented Streptococcus pneumoniae infection within the past 5 years.
  4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646398

Locations
Japan
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Oda Clinic
Shinjuku-ku, Tokyo, Japan
Sone Clinic
Shinjuku-ku, Tokyo, Japan
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, Japan
Medical Co.LTA PS Clinic
Fukuoka, Japan
Uzumasa Medical Clinic
Kyoto, Japan
Senbon Hospital
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646398     History of Changes
Other Study ID Numbers: B1851088
Study First Received: May 10, 2012
Results First Received: July 17, 2013
Last Updated: July 17, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
13VPNC
23VPS

ClinicalTrials.gov processed this record on November 20, 2014