Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044316

Enrollment

670

Registered

2010-01-07

Start date

2010-04-30

Completion date

2010-12-31

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, Booster

Brief summary

This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Interventions

BIOLOGICALHaemophilus influenzae type b (Hib) vaccine

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Months

Healthy volunteers

Yes

Inclusion criteria

* Infants 6-12 months of age.

Exclusion criteria

* Prior Hib vaccine administration. * History of serious reaction(s) following vaccination. * Any 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 last vaccination	30 days after last vaccination

Secondary

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

Countries

China

Outcome results

None listed

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