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

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

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

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: Haemophilus influenzae type b

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shijiazhuang, China, 050800
    • Vaccination site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.	90 days

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (ESTIMATE): August 14, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 6, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: vaccine; children; prevention; haemophilus influenzae type b
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Orthomyxoviridae Infections; Pasteurellaceae Infections; Influenza, Human; Haemophilus Infections
• Other Study ID Numbers: M37P1