Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
|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|
|Primary Completion Date :||February 2008|
|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.
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|