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

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.

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Key information

Conditions

Haemophilus Influenzae Type b (Hib) Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Pasteurellaceae Infections

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hebei Province, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haemophilus influenzae type b (Hib) vaccine

Biological

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.

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jan 7, 2010
Registry last updated: Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed