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

Novartis Vaccines660 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

660

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Interventions

Haemophilus influenzae type b (Hib) vaccineBIOLOGICAL

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines

Eligibility

Sex: ALLMin age: 365 DaysMax age: 569 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Hebei Province, China

Outcomes

Primary Outcomes

Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination

Time frame: 30 days after last vaccination

Secondary Outcomes

Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)

Time frame: 30 days post last vaccination

Data from ClinicalTrials.gov

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