Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 50 - 59 |
Updated: | 11/30/-0001 |
Start Date: | September 2007 |
End Date: | January 2014 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
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 (TIV) 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.
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
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