Prevenar (13v) Infant Drug Use Investigation

Completed

• Conditions: Infants
• Interventions: Drug: Prevenar (13v)

• Registration Number: NCT02119104
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-03
• Results First Submitted: 2017-04-05
• Results First Submitted QC: 2017-04-05
• Last Update Submitted: 2017-04-05
• Results First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1087

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prevenar (13v)	Prevenar (13v)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Reactions	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.