You are here

Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Advantage, Inc.
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Influenza
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-59 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female aged 50 to 59 years

- Determined by medical history, physical examination and clinical judgement to be
eligible for the study

- Able to complete electronic diary

- Available for the 5 year 9 month duration of the study

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

- Previous vaccination with any licensed or experimental pneumococcal vaccine

- Allergic to egg proteins and chicken proteins

- History of Guillian-Barre syndrome

- Vaccination with TIV within 6 months before study start

- Vaccination with diphtheria-containing vaccine within 6 months of study start

- Serious chronic disorders including immunodeficiency or metastatic malignancy

- Known or suspected hypersensitivity to any vaccine or vaccine component

NCT00521586
Pfizer
Completed
Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: 13 valent pneumococcal conjugate vaccine
    TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
    Other Name: 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
  • Biological: 13 valent pneumococcal conjugate vaccine
    TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
    Other Name: 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle
  • 1
    arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine
  • 2
    arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1116
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 50 to 59 years
  • Determined by medical history, physical examination and clinical judgement to be eligible for the study
  • Able to complete electronic diary
  • Available for the 5 year 9 month duration of the study

Exclusion Criteria:

  • Previous vaccination with any licensed or experimental pneumococcal vaccine
  • Allergic to egg proteins and chicken proteins
  • History of Guillian-Barre syndrome
  • Vaccination with TIV within 6 months before study start
  • Vaccination with diphtheria-containing vaccine within 6 months of study start
  • Serious chronic disorders including immunodeficiency or metastatic malignancy
  • Known or suspected hypersensitivity to any vaccine or vaccine component
Sexes Eligible for Study: All
50 Years to 59 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00521586
6115A1-3001
B1851020 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now