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

Haemophilus Influenzae Type b (Hib) Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226953
• Other study ID #: V37_07E1
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2010
• Last updated: December 27, 2011
• Start date: October 2010
• Est. completion date: March 2011

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 immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 365 Days to 569 Days

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b (Hib) Infection

Intervention

Biological:
• Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines

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 (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination		30 days after last vaccination	No
Secondary	Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)		30 days post last vaccination	Yes