Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

Novartis

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type b

Treatments

Biological: Commercial Haemophilus influenzae type b vaccine

Biological: Haemophilus influenzae type b vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00808392

M37P2

Details and patient eligibility

About

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Enrollment

916 patients

Sex

All

Ages

2 to 4 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infants of either sex, aged 2 - 4 months
In good health as determined by:
- medical history
- physical examination
- clinical judgment of the investigator;
Available for all visits scheduled in the study and able to comply with all study regulations
For whom written informed consent has been obtained from at least one parent or legal guardian

Exclusion criteria

Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
Infants who have received any other Haemophilus influenzae type b immunization dose before
Infants who presented a previous disease potentially related to Haemophilus influenzae type b
Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
Premature (before 37th week of gestation) or birth weight less than 2500 g
History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
Subjects with a clinically significant genetic anomaly
Treatment with corticosteroids or other immunosuppressive drugs
Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
Participation in any other investigational trial simultaneously
Planned surgery during the study period
Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective