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

Haemophilus Influenzae Type b (Hib) Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044316
• Other study ID #: V37_07
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2010
• Last updated: December 27, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese State Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b (Hib) Infection
• Influenza, Human
• Tetanus

Intervention

Biological:
• Haemophilus 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-PRP antibody levels at day 31 post last vaccination		30 days after last vaccination	No
Secondary	Solicited local and systemic reactions, AEs, and SAEs		30 days post last vaccination	Yes