Trial record 3 of 163 for:    "Haemophilus influenzae"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00734565
First received: August 12, 2008
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Haemophilus Influenzae Type b
Biological: Haemophilus influenzae type b
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Months to 20 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734565

Locations
China
Vaccination site
Shijiazhuang, China, 050800
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00734565     History of Changes
Other Study ID Numbers: M37P1
Study First Received: August 12, 2008
Last Updated: February 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
vaccine
prevention
haemophilus influenzae type b
children

Additional relevant MeSH terms:
Haemophilus Infections
Influenza, Human
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014