Prevenar (13v) Infant Drug Use Investigation

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.

Completed

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Key information

Conditions

Infants

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevenar (13v)

Drug

Prevenar (13v)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Apr 21, 2014
Registry last updated: Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed