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A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654263
First Posted: July 31, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: August 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition: Pneumococcal Infection
Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were healthy adult males and females, 55 through 74 years of age, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 10OCT2012 and 03MAR2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
IIA: Age 55-64, Previous PPSV23, Single Injection Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIB: Age 65-74, Previous PPSV23, Single Injection Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIAA: Age 55-64, Previous PPSV23, Two Injections Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIBB: Age 65 - 74, Previous PPSV23, Two Injections Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.

Participant Flow:   Overall Study
    IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection   IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection   IIA: Age 55-64, Previous PPSV23, Single Injection   IIB: Age 65-74, Previous PPSV23, Single Injection   IIAA: Age 55-64, Previous PPSV23, Two Injections   IIBB: Age 65 - 74, Previous PPSV23, Two Injections
STARTED   164   147   139   145   140   149 
COMPLETED   164   147   137   144   139   148 
NOT COMPLETED   0   0   2   1   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants are included in the baseline analysis population.

Reporting Groups
  Description
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
IIA: Age 55-64, Previous PPSV23, Single Injection Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIB: Age 65-74, Previous PPSV23, Single Injection Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIAA: Age 55-64, Previous PPSV23, Two Injections Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
IIBB: Age 65-74, Previous PPSV23, Two Injections Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
Total Total of all reporting groups

Baseline Measures
   IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection   IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection   IIA: Age 55-64, Previous PPSV23, Single Injection   IIB: Age 65-74, Previous PPSV23, Single Injection   IIAA: Age 55-64, Previous PPSV23, Two Injections   IIBB: Age 65-74, Previous PPSV23, Two Injections   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   147   139   145   140   149   884 
Age 
[Units: Participants]
Count of Participants
             
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      164 100.0%      0   0.0%      139 100.0%      0   0.0%      140 100.0%      0   0.0%      443  50.1% 
>=65 years      0   0.0%      147 100.0%      0   0.0%      145 100.0%      0   0.0%      149 100.0%      441  49.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (2.8)   67.6  (2.6)   60.8  (2.7)   70.5  (2.0)   61.0  (2.8)   70.3  (2.0)   65.0  (5.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      128  78.0%      70  47.6%      87  62.6%      69  47.6%      80  57.1%      78  52.3%      512  57.9% 
Male      36  22.0%      77  52.4%      52  37.4%      76  52.4%      60  42.9%      71  47.7%      372  42.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      5   3.0%      3   2.0%      7   5.0%      1   0.7%      2   1.4%      2   1.3%      20   2.3% 
Not Hispanic or Latino      159  97.0%      144  98.0%      132  95.0%      143  98.6%      138  98.6%      147  98.7%      863  97.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      1   0.7%      0   0.0%      0   0.0%      1   0.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      1   0.7%      0   0.0%      0   0.0%      1   0.1% 
Asian      0   0.0%      2   1.4%      1   0.7%      5   3.4%      4   2.9%      2   1.3%      14   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8   4.9%      4   2.7%      18  12.9%      6   4.1%      17  12.1%      8   5.4%      61   6.9% 
White      154  93.9%      140  95.2%      114  82.0%      132  91.0%      116  82.9%      138  92.6%      794  89.8% 
More than one race      2   1.2%      1   0.7%      4   2.9%      0   0.0%      2   1.4%      1   0.7%      10   1.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      2   1.4%      1   0.7%      1   0.7%      0   0.0%      4   0.5% 
Region of Enrollment 
[Units: Participants]
             
United States   164   147   139   145   140   149   884 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Solicited Local and Systemic Adverse Events   [ Time Frame: Days 0 to Day 7 post vaccination ]

2.  Primary:   Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.   [ Time Frame: Up to Day 28 post vaccination ]

3.  Primary:   Number of Participants Reporting Vaccine-related Serious Adverse Events.   [ Time Frame: Up to Day 180 post vaccination ]

4.  Primary:   Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.   [ Time Frame: Day 0 and Day 28 post vaccination ]

5.  Secondary:   Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.   [ Time Frame: Day 0 and Day 180 post vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa A. Jackson, MD, MPH
Organization: Group Health Research Institute
phone: 206-442-5216
e-mail: Jackson.L@ghc.org



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01654263     History of Changes
Other Study ID Numbers: 11-0034
HHSN272201300018I
First Submitted: July 19, 2012
First Posted: July 31, 2012
Results First Submitted: August 11, 2016
Results First Posted: January 23, 2017
Last Update Posted: March 27, 2017