Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01025544

Enrollment

846

Registered

2009-12-03

Start date

2009-09-30

Completion date

2010-04-30

Last updated

2011-12-08

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, Booster

Brief summary

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Interventions

BIOLOGICALVaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

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

BIOLOGICALHiberix (Haemophilus influenzae type b (Hib) vaccine)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

* Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion criteria

* Prior Hib booster administration. * History of serious reaction(s) following vaccination. * Vaccination within 14 days of study vaccination. * Known or suspected immune impairment. * For additional entry criteria please refer to the protocol.

Design outcomes

Primary

Measure	Time frame
Anti-PRP antibody levels at day 31 post booster	31 days after vaccination

Secondary

Measure	Time frame
Solicited local and systemic reactions, AEs, and SAEs	30 days post vaccination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026