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

Primary Purpose

Haemophilus Influenzae Type b

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Haemophilus influenzae type b
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b focused on measuring vaccine, prevention, haemophilus influenzae type b, children

Eligibility Criteria

2 Months - 20 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vaccination site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.

Secondary Outcome Measures

Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.

Full Information

First Posted
August 12, 2008
Last Updated
February 6, 2012
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00734565
Brief Title
Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b
Keywords
vaccine, prevention, haemophilus influenzae type b, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Haemophilus influenzae type b
Intervention Description
1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months
Primary Outcome Measure Information:
Title
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Vaccination site
City
Shijiazhuang
ZIP/Postal Code
050800
Country
China

12. IPD Sharing Statement

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

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