Prevenar (13v) Infant Drug Use Investigation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1087 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prevenar (13v)

Intervention Type DRUG

Prevenar (13v)

Interventions

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Prevenar (13v)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No