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

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type b (Hib) Infection
• Interventions: Biological: Haemophilus influenzae type b (Hib) vaccine

• Registration Number: NCT01226953
• Lead Sponsor: Novartis Vaccines

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-27
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Haemophilus influenzae type b (Hib) vaccine	-
Arm 2	Haemophilus influenzae type b (Hib) vaccine	-

Primary Outcome Measures

Name	Time	Method
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination	30 days after last vaccination

Secondary Outcome Measures

Name	Time	Method
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)	30 days post last vaccination