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

Haemophilus Influenzae Type b Clinical Trial

Official title:

A Phase I, Single-arm, Single-center Study to Investigate Safety and Reactogenicity of Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b in Healthy Children Aged 16 - 20 Months and Infants Aged 2 - 4 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734565
• Other study ID #: M37P1
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2008
• Last updated: February 6, 2012
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 20 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b
• Influenza, Human

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Vaccination site	Shijiazhuang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.		30 days	Yes
Secondary	Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.		90 days	Yes