C-reactive protein response to newborn hepatitis B immunisation

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000043932

Enrollment

Registered

2011-01-13

Start date

2001-12-12

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

CRP may be useful in the newborn period as an infection screen. Universal hepatitis B immunisation may limit the usefulness of CRP if an inflammatory response is induced. This study looks at CRP response after birth in a group of babies where infection can definitely be excluded. Babies are randomised to recieve vaccination at either 24 hours of age or after 96 hours. A CRP level is taken each day and the levels in the 2 groups are compared.

Interventions

Term babies born by elective caesarean section are randomised to recieve routine intramuscular monovalent hepatitis B immunisation (0.5mL of H-B-Vax II, CSL Biotherapies/Merck & Co Inc, containing 5 micrograms of hepatitis B surface antigen adsorbed onto 0.25 mg of aluminium hydroxide in 0.5 mL) either at 24 or after 96 hours of age. Daily CRP levels are taken at 24, 48, 72 and 96 hours. Administration of vaccine at either 24 or 96 hours is within standard practice.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

24 Hours to 24 Hours

Healthy volunteers

Yes

Inclusion criteria

Gestation 37-40 weeks Elective caesarean section without labour or membrane rupture Well at 24 hours of age Parental intention to give birth dose of hepatitis B vaccine

Exclusion criteria

Gestation <37 weeks or >40 weeks Unwell at 24 hours of age Parents don't intend to give birth dose of hepatitis B vaccine

Outcome results