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

NCT ID: NCT00734565

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-10-31

Brief Summary

This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children

Conditions

Haemophilus Influenzae Type b

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Haemophilus influenzae type b

Intervention Type: BIOLOGICAL

1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months

Interventions

Haemophilus influenzae type b

1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Infants of either sex, aged 16 - 20 months / 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;
• written informed consent 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 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;
• infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already);
• 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) and/or 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;
• treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
• any vaccination administered within 2 weeks (14 days) before enrollment;
• 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 20 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Vaccination site

Shijiazhuang, , China

Countries

China

Other Identifiers

M37P1

Identifier Type: -

Identifier Source: org_study_id