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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

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ClinicalTrials.gov Identifier: NCT01646398
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

May 10, 2012
July 20, 2012
July 17, 2013
September 20, 2013
September 20, 2013
June 2012
October 2012   (Final data collection date for primary outcome measure)
  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination [ Time Frame: One month after vaccination ]
    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 ]
    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.
  • The serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMT) for the 12 common serotypes contained in 13vPnC and 23vPS [ Time Frame: 1 month after vaccination ]
  • The proportion of subjects achieving a 4-fold rise in OPA titers for serotype 6A. [ Time Frame: 1 month after vaccination ]
Complete list of historical versions of study NCT01646398 on ClinicalTrials.gov Archive Site
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 ]
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).
The serotype-specific OPA GMTs for the 12 common serotypes contained in 13vPnC and 23vPS and serotype 6A [ Time Frame: 1 month after vaccination ]
  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ]
    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 ]
    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.
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pneumococcal Vaccines
  • 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
  • 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
  • Experimental: >= 65-year age group-13vPnC
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: >= 65-year age group-23vPS
    Intervention: Biological: 23-valent pneumococcal polysaccharide vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
764
734
October 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01646398
B1851088
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

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