Clinical trial NCT00808392: Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Keywords: vaccine
prevention
haemophilus influenzae type b
children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 916
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
timeFrame: 90 days
Secondary outcomes:
measure: Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.
timeFrame: 90 days
Other outcomes:
Locations:
city: Dingxing
country: China
facility: the CDC of Dingxing county(site no 02)
state: Hebei
city: Zhengding
country: China
facility: The CDC of Zhengding county(site no 01)
state: Hebei
Study officials:
References: