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

A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

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.

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