Clinical trial NCT01646398: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
Keywords: 13VPNC
23VPS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 764
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
timeFrame: One month after vaccination
measure: Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
timeFrame: One month after vaccination
Secondary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
timeFrame: One month after vaccination
Other outcomes:
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
Locations:
city: Itoshima
country: Japan
facility: Seishinkai Inoue Hospital
state: Fukuoka
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Shinjuku-ku
country: Japan
facility: Oda Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Sone Clinic
state: Tokyo
city: Sumida-ku
country: Japan
facility: Medical Co. LTA Sumida Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Medical Co.LTA PS Clinic
city: Kyoto
country: Japan
facility: Uzumasa Medical Clinic
city: Osaka
country: Japan
facility: Senbon Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: