Prevenar (13v) Infant Drug Use Investigation

Pfizer

Status: Completed

Conditions: Infants

Treatments: Drug: Prevenar (13v)

Study type: Observational

Funder types: Industry

Identifiers

NCT02119104

B1851122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,087 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

1,087 participants in 1 patient group

Prevenar (13v)

Treatment:

Drug: Prevenar (13v)