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Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Generally healthy male or female adults 65 years of age or older.

- Available for the duration of the trial - approximately 2 months.

- No previous vaccination with any pneumococcal vaccine.

- No history of severe adverse reaction associated with a vaccine.

- No allergy to egg proteins (eggs or egg products) and chicken proteins.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Generally healthy male or female adults 65 years of age or older.

- Available for the duration of the trial - approximately 2 months.

- No previous vaccination with any pneumococcal vaccine.

- No history of severe adverse reaction associated with a vaccine.

- No allergy to egg proteins (eggs or egg products) and chicken proteins.

NCT00492557
Pfizer
Completed
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

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Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine
The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: 13-valent pneumococcal conjugate vaccine
    Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.
  • Biological: 13vPnC + TIV
    Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.
  • Experimental: 13vPnC+TIV Followed by Placebo 1 month later
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: Placebo+TIV Followed by 13vPnC 1 month later
    Intervention: Biological: 13vPnC + TIV
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1185
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generally healthy male or female adults 65 years of age or older.
  • Available for the duration of the trial - approximately 2 months.
  • No previous vaccination with any pneumococcal vaccine.
  • No history of severe adverse reaction associated with a vaccine.
  • No allergy to egg proteins (eggs or egg products) and chicken proteins.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00492557
6115A1-3008
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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