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Prevenar (13v) Infant Drug Use Investigation

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NCT02119104

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT02119104
Pfizer
Completed
Prevenar (13v) Infant Drug Use Investigation

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[email protected]

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Similar Trials

Infants
Prevenar (13v) Infant Drug Use Investigation
NCT02119104
All Genders
Prevenar (13v) Infant Drug Use Investigation
Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Drug: Prevenar (13v)
Prevenar (13v)
Prevenar (13v)
Intervention: Drug: Prevenar (13v)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1087
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 6 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02119104
B1851122
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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