MedDataX Logo

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

NCT ID: NCT01646398

Last Updated: 2013-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumococcal Vaccines Pneumococcal Conjugate Vaccine

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

13VPNC 23VPS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

>= 65-year age group-13vPnC

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

>= 65-year age group-23vPS

Group Type ACTIVE_COMPARATOR

23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

13-valent pneumococcal conjugate vaccine

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

13vPnC 23VPS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Co.LTA PS Clinic

Fukuoka, Fukuoka, Japan

Site Status

Seishinkai Inoue Hospital

Itoshima, Fukuoka, Japan

Site Status

Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Site Status

Uzumasa Medical Clinic

Kyoto, Kyoto, Japan

Site Status

Senbon Hospital

Osaka, Osaka, Japan

Site Status

Oda Clinic

Shinjuku-ku, Tokyo, Japan

Site Status

Sone Clinic

Shinjuku-ku, Tokyo, Japan

Site Status

Medical Co. LTA Sumida Hospital

Sumida-ku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851088&StudyName=A%20Phase%203%20Trial%20Evaluating%20the%20Safety%2C%20Tolerability%2C%20and%20Immunogenicity%20of%20a%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20in%20Japanese%20Elde

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1851088

Identifier Type: -

Identifier Source: org_study_id