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

NCT01646398 | Completed Phase 3 Results

• 1 other identifier: B1851088
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 8

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.

Conditions

Pneumococcal Vaccines; Pneumococcal Conjugate Vaccine

Keywords

13VPNC; 23VPS

Outcome Measures

Primary Outcomes (2)

• Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 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).

  One month after vaccination

• Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 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.

  One month after vaccination

Secondary Outcomes (1)

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

  One month after vaccination

Other Outcomes (2)

• Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination

  Within 14 days after vaccination

• Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination

  Within 14 days after vaccination

Study Arms (2)

>= 65-year age group-13vPnC

EXPERIMENTAL

Biological: 13-valent pneumococcal conjugate vaccine

>= 65-year age group-23vPS

ACTIVE COMPARATOR

Biological: 23-valent pneumococcal polysaccharide vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

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

Also known as: 13vPnC

>= 65-year age group-13vPnC

23-valent pneumococcal polysaccharide vaccine BIOLOGICAL

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

Also known as: 23VPS

>= 65-year age group-23vPS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
• Previous vaccination with any licensed or experimental pneumococcal vaccine.
• Documented Streptococcus pneumoniae infection within the past 5 years.
• Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Medical Co.LTA PS Clinic

Fukuoka, Fukuoka, Japan

Location

Seishinkai Inoue Hospital

Itoshima, Fukuoka, Japan

Location

Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Location

Uzumasa Medical Clinic

Kyoto, Kyoto, Japan

Location

Senbon Hospital

Osaka, Osaka, Japan

Location

Oda Clinic

Shinjuku-ku, Tokyo, Japan

Location

Sone Clinic

Shinjuku-ku, Tokyo, Japan

Location

Medical Co. LTA Sumida Hospital

Sumida-ku, Tokyo, Japan

Location

Related Links

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

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: July 20, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 20, 2013
• Results First Posted: September 20, 2013

Record last verified: 2013-07

Locations

JP (8)