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

Phase 3

Completed

• Conditions: Pneumococcal Vaccines; Pneumococcal Conjugate Vaccine
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

• Registration Number: NCT01646398
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-10
• Study Start: 2012-06
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-07
• Results First Submitted: 2013-07-17
• Results First Submitted QC: 2013-07-17
• Last Update Submitted: 2013-07-17
• Results First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
>= 65-year age group-13vPnC	13-valent pneumococcal conjugate vaccine	-
>= 65-year age group-23vPS	23-valent pneumococcal polysaccharide vaccine	-

Primary Outcome Measures

Name	Time	Method
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination	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	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.

Secondary Outcome Measures

Name	Time	Method
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination	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).

Trial Locations

Locations (8)

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