Haemophilus Influenzae Type b
Conditions
Keywords
vaccine, prevention, haemophilus influenzae type b, children
Brief summary
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.
Interventions
BIOLOGICALHaemophilus influenzae type b vaccine
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
BIOLOGICALCommercial Haemophilus influenzae type b vaccine
3 doses one month apart of Haemophilus influenzae type b vaccine.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Months to 4 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated. | 90 days |
Countries
China
Outcome results
None listed