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

Novartis Vaccines700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

700

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Interventions

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

a single dose was administered

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

a single dose was administered

Eligibility

Sex: ALLMin age: 13 MonthsMax age: 59 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Hebei Province, China

Outcomes

Primary Outcomes

Anti-PRP antibody levels at day 31 post last vaccination

Time frame: 30 days after last vaccination

Secondary Outcomes

Solicited local and systemic reactions, AEs, and SAEs

Time frame: 30 days post last vaccination

Data from ClinicalTrials.gov

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