Prevenar (13v) Infant Drug Use Investigation

NCT02119104

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-6 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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InfantsPrevenar (13v) Infant Drug Use Investigation
NCT02119104
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date March 2017