Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
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|ClinicalTrials.gov Identifier: NCT00492557|
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : February 17, 2012
Last Update Posted : February 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infections||Biological: 13-valent pneumococcal conjugate vaccine Biological: 13vPnC + TIV||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: 13vPnC+TIV Followed by Placebo 1 month later||
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.
|Active Comparator: Placebo+TIV Followed by 13vPnC 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.
- TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) [ Time Frame: Baseline and 1 month after TIV vaccination ]Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
- 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 1 month after 13vPnC vaccination ]IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492557
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|