We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109108
First Posted: April 22, 2010
Last Update Posted: March 14, 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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stephen Pelton, Boston Medical Center
Results First Submitted: January 25, 2017  
Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Prospective
Condition: Nasopharyngeal Carriage of S. Pneumoniae

  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
Children aged 0<60 months with non-toxic appearance presenting for well child or urgent care visit at urban hospital recruited from July 1, 2010 - March 27, 2015; each child could be enrolled only once per 60 day period.

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
Children 0<2 Years of Age Children 0<2 years of age with and without respiratory tract infection
Children 2<5 Years of Age Children 2<5 years of age with and without respiratory tract infection

Participant Flow:   Overall Study
    Children 0<2 Years of Age   Children 2<5 Years of Age
STARTED   4035   4755 
COMPLETED   4035   4755 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Children 0<2 Years of Age Children 0<2 years of age with and without concurrent respiratory tract infection
Children 2<5 Years of Age Children 2<5 years of age with and without concurrent respiratory tract infection
Total Total of all reporting groups

Baseline Measures
   Children 0<2 Years of Age   Children 2<5 Years of Age   Total 
Overall Participants Analyzed 
[Units: Participants]
 4035   4755   8790 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4035 100.0%      4755 100.0%      8790 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Months]
Mean (Standard Deviation)
 12.1  (5.7)   40.0  (10.3)   27.2  (16.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1935  48.0%      2402  50.5%      4337  49.3% 
Male      2100  52.0%      2353  49.5%      4453  50.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      7   0.2%      6   0.1%      13   0.1% 
Asian      123   3.0%      124   2.6%      247   2.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.0%      1   0.0% 
Black or African American      2719  67.4%      3445  72.5%      6164  70.1% 
White      445  11.0%      351   7.4%      796   9.1% 
More than one race      739  18.3%      828  17.4%      1567  17.8% 
Unknown or Not Reported      2   0.0%      0   0.0%      2   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4035   4755   8790 
Pneumococcal risk factors 
[Units: Participants]
Count of Participants
     
Current RTI (Respiratory tract infection)       
Yes      1839  45.6%      2108  44.3%      3947  44.9% 
No      2196  54.4%      2647  55.7%      4843  55.1% 
Recent antibiotic use (last 14 days)       
Yes      535  13.3%      451   9.5%      986  11.2% 
No      3500  86.7%      4304  90.5%      7804  88.8% 
Ever Breastfed       
Yes      3222  79.9%      3684  77.5%      6906  78.6% 
No      813  20.1%      1071  22.5%      1884  21.4% 
Current daycare attendance       
Yes      1217  30.2%      2887  60.7%      4104  46.7% 
No      2818  69.8%      1868  39.3%      4686  53.3% 
PCV13 Immune       
Yes      3240  80.3%      3923  82.5%      7163  81.5% 
No      795  19.7%      832  17.5%      1627  18.5% 


  Outcome Measures

1.  Primary:   Nasopharngeal Colonization With PCV13 S. Pneumoniae   [ Time Frame: Study years 1-5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen I Pelton
Organization: Boston Medical Center
phone: 617-414-5591
e-mail: spelton@bu.edu



Responsible Party: Stephen Pelton, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01109108     History of Changes
Other Study ID Numbers: H-28757
First Submitted: April 21, 2010
First Posted: April 22, 2010
Results First Submitted: January 25, 2017
Results First Posted: March 14, 2017
Last Update Posted: March 14, 2017