Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

PHASE4CompletedINTERVENTIONAL
Enrollment

882

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Interventions
BIOLOGICAL

13-valent pneumococcal conjugate vaccine

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

BIOLOGICAL

Seasonal Inactivated Influenza Vaccine

One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

OTHER

Placebo

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

OTHER

Placebo

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

BIOLOGICAL

Seasonal Inactivated Influenza Vaccine

One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

Trial Locations (44)

13760

Regional Clinical Research, Inc., Endwell

13901

United Medical Associates, Binghamton

14609

Rochester Clinical Research, Inc., Rochester

15106

Preferred Primary Care Physicians, Inc., Carnegie

19335

Brandywine Clinical Research, Downingtown

27103

Clinical Trials of America, Inc., Winston-Salem

PMG Research of Winston-Salem, Winston-Salem

27408

PharmQuest, Greensboro

27518

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary

28602

PMG Research of Hickory, LLC, Hickory

29464

PMG Research of Charleston, Mt. Pleasant

31406

Meridian Clinical Research, Savannah

32205

Westside Center for Clinical Research, Jacksonville

32216

Jacksonville Center for Clinical Research, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

33781

Radiant Research, Inc., Pinellas Park

35216

Achieve Clinical Research, LLC, Birmingham

35802

Optimal Research (Formerly Accelovance), Huntsville

37620

Internal Medicine and Pediatric Associates of Bristol, PC, Bristol

37920

Volunteer Research Group, Knoxville

43212

Radiant Research, Inc, Columbus

45005

Prestige Clinical Research, Franklin

46545

Optimal Research, LLC, Mishawaka

51503

Clinical Research Advantage, Inc/Ridge Family Practice, Council Bluffs

66219

Johnson County Clin-Trials, Inc., Lenexa

68005

Meridian Clinical Research, Bellevue

68134

Meridian Clinical Research, LLC, Omaha

68701

Meridian Clinical Research, Norfolk

70002

Benchmark Research, Metairie

76735

Benchmark Research, Fort Worth

78229

Diagnostics Research Group, San Antonio

78705

Benchmark Research, Austin

84095

J. Lewis Research, Inc. / Jordan River Family Medicine, South Jordan

84109

J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City

84121

J. Lewis Research, Inc. / Foothill Family Clinic South, Salt Lake City

84123

Radiant Research, Inc., Murray

85251

Radiant Research, Inc., Scottsdale

89104

Clinical Research Center of Nevada, LLC, Las Vegas

89128

Clinical Research Advantage, Inc., Las Vegas

94108

Benchmark Research, San Francisco

94612

Kaiser Permanente Vaccine Study Center, Oakland

95051

Kaiser Pemanente Santa Clara, Santa Clara

95823

Kaiser Permanante South. Sacramento, Sacramento

02886

Omega Medical Research, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02124161 - Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults. | Biotech Hunter | Biotech Hunter