Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125527

Enrollment

700

Registered

2010-05-18

Start date

2009-08-31

Completion date

2010-04-30

Last updated

2016-12-01

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 single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Interventions

BIOLOGICALMonovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

BIOLOGICALTetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Months to 59 Months

Healthy volunteers

Yes

Inclusion criteria

* Infants 13-59 months of age.

Exclusion criteria

* Prior Hib vaccine administration. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment. * Premature (before 37th week of gestation) or birth weight less than 2500g * 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: Feb 4, 2026