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

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

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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

365 day–569 day

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 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.

Treatment and study plan

Haemophilus influenzae type b (Hib) vaccine

Biological

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

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Oct 22, 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