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Completed

NCT Number: 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

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.

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Key information

Conditions

Pneumococcal Vaccines Pneumococcal Conjugate Vaccine

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Co.LTA PS Clinic, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

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

Other names: 13vPnC

23-valent pneumococcal polysaccharide vaccine

Biological

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

Other names: 23VPS

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2012
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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