Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against HAEMOPHILUS INFLUENZAE TYPE b.
- Conditions
- Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-005036-33-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 40
1) Infants of either sex, aged 16 - 20 months / 2 - 4 months;
2) in good health as determined by:
• medical history
• physical examination
• clinical judgment of the investigator.
3) available for all visits scheduled in the study and able to comply with all study
regulations;
4) written informed consent obtained, from at least one parent or legal guardian;
Informed consent must be obtained for all the subjects before enrollment into the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
2) infants who presented a previous disease potentially related to Haemophilus influenzae type b;
3) infants who had household contact and/or intimate exposure in the previous 30mdays to an individual with ascertained Haemophilus influenzae type b disease;
4) infants who have received any other Haemophilus influenzae type b immunizationmdose before (for 16-20 months old children who have received a booster vaccination already);
5) premature (before 37th week of gestation) or birth weight less than 2500 g;
6) history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
7) 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;
8) subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
9) known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
10) subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder;
11) subjects with a clinically significant genetic anomaly;
12) treatment with corticosteroids or other immunosuppressive drugs;
13) treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
14) any vaccination administered within 2 weeks (14 days) before enrollment;
15) participation in any other investigational trial simultaneously;
16) planned surgery during the study period;
17) any condition, which, in the opinion of the investigator, might interfere with the
evaluation of the study objective;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine safety and tolerability of Vaxem Hib when given to 20 healthy children aged 16 – 20 months and subsequently to 20 healthy infants aged 2 - 4 months.;Secondary Objective: NA;Primary end point(s): 1. Number of subjects with reported local and systemic reactions after each vacination.<br><br>2. Number of subjects with reported Serious adverse events (SAE) and/ or adverse events necessitating a physician's visit and/ or resulting in premature withdrawal from the study.<br><br>3. All adverse events are colllected throughout the study.;Timepoint(s) of evaluation of this end point: 1. 1 to 7 days after each vaccination.<br><br>2. Days 0 to Day 30.<br><br>3. Throughout the study.<br><br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA