Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

Novartis Vaccines670 enrolled

Overview

This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

670

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 - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Infants 6-12 months of age. Exclusion Criteria: * Prior Hib vaccine administration. * History of serious reaction(s) following vaccination. * Any 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 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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