Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

Novartis Vaccines846 enrolled

Overview

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

846

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Interventions

Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)BIOLOGICAL

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

Hiberix (Haemophilus influenzae type b (Hib) vaccine)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Toddlers 12-18 months of age who have previously participated in study M37P2. Exclusion Criteria: * Prior Hib booster administration. * History of serious reaction(s) following vaccination. * Vaccination within 14 days of study vaccination. * Known or suspected immune impairment. * 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 booster

Time frame: 31 days after vaccination

Secondary Outcomes

Solicited local and systemic reactions, AEs, and SAEs

Time frame: 30 days post vaccination

Data from ClinicalTrials.gov

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