Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01226953

Enrollment

660

Registered

2010-10-22

Start date

2010-10-31

Completion date

2011-03-31

Last updated

2011-12-30

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

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Keywords

Haemophilus influenzae type b (Hib), Vaccine, Anti-PRP antibody

Brief summary

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Interventions

BIOLOGICALHaemophilus influenzae type b (Hib) vaccine

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

365 Days to 569 Days

Healthy volunteers

Yes

Inclusion criteria

* Infants 365-569 days of age.

Exclusion criteria

* Subjects who already received a booster dose of Hib vaccine. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment.

Design outcomes

Primary

Measure	Time frame
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination	30 days after last vaccination

Secondary

Measure	Time frame
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)	30 days post last vaccination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026