Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02119104
Previous Study | Return to List | Next Study

Prevenar (13v) Infant Drug Use Investigation

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.
 
ClinicalTrials.gov Identifier: NCT02119104
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date March 5, 2014
First Posted Date April 21, 2014
Results First Submitted Date April 5, 2017
Results First Posted Date June 19, 2017
Last Update Posted Date June 19, 2017
Study Start Date March 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2017)
Number of Participants With Adverse Reactions [ Time Frame: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination. ]
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Original Primary Outcome Measures
 (submitted: April 17, 2014)
Number of the participants with adverse reaction [ Time Frame: 52 weeks (MAX) ]
Change History Complete list of historical versions of study NCT02119104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevenar (13v) Infant Drug Use Investigation
Official Title Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Brief Summary The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
Detailed Description The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation.
Condition Infants
Intervention Drug: Prevenar (13v)
Prevenar (13v)
Study Groups/Cohorts Prevenar (13v)
Intervention: Drug: Prevenar (13v)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 18, 2016)
1087
Original Estimated Enrollment
 (submitted: April 17, 2014)
1000
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
  • Infants aged 2 months, inclusive, to 7 months, exclusive
  • Infants with no history of administration of pneumococcal vaccines including Prevenar 13
  • Infants expected to receive 4 vaccinations

Exclusion Criteria:

  • Vaccines must not be performed if the vaccinee corresponds to any of the following:
  • Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
  • Persons with evident pyrexia
  • Persons who evidently have serious acute diseases
  • Besides the persons listed above, persons who are in a status inappropriate for immunization
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months to 6 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02119104
Other Study ID Numbers B1851122
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017