Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU

Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU - Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008025

Enrollment

200

Registered

2012-05-24

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse events of vaccines

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants at NICU or GCU Body weight 1500g or over Written consent is obtained

Exclusion criteria

Exclusion criteria: Previous history of vaccinations Acute illness such as acute infection, acute metabolic disorder, acute renal disorder, acute cardiac disorder, acute neurological disorder and acuter respiratory disorder 13 trisomy and 18 trisomy including mosaic Patients who were considered as inappropriate to participate in this study by responsible physicians

Design outcomes

Primary

Measure	Time frame
Frequency and type of adverse events following vaccines administration	—

Secondary

Measure	Time frame
Factors associated with adverse events following vaccines administration	—

Countries

Japan

Contacts

Public ContactKazuhiko Morikawa

Tokyo Metropolitan Children's Medical Center Clinical Research

yoshihiko_morikawa@tmhp.jp042-300-5111

Outcome results