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

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


Ages Eligible for Study:   2 Months to 20 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00734565

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

Responsible Party: Novartis ( Novartis Vaccines ) 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:
haemophilus influenzae type b

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases processed this record on May 23, 2016