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
We found this trial at
18
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials