Safety and Immunogenicity 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:
NCT00808392
First received: December 12, 2008
Last updated: December 26, 2011
Last verified: December 2011
  Purpose

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.


Condition Intervention Phase
Haemophilus Influenzae Type b
Biological: Haemophilus influenzae type b vaccine
Biological: Commercial Haemophilus influenzae type b vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 916
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Haemophilus influenzae type b vaccine
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
Active Comparator: 2 Biological: Commercial Haemophilus influenzae type b vaccine
3 doses one month apart of Haemophilus influenzae type b vaccine.

  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants of either sex, aged 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
  • For whom written informed consent has been 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 have received any other Haemophilus influenzae type b immunization dose before
  • 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
  • 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) or/and 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
  • Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
  • Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
  • 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 ClinicalTrials.gov identifier: NCT00808392

Locations
China, Hebei
the CDC of Dingxing county(site no 02)
Dingxing, Hebei, China, 072650
The CDC of Zhengding county(site no 01)
Zhengding, Hebei, China, 050800
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00808392     History of Changes
Other Study ID Numbers: M37P2
Study First Received: December 12, 2008
Last Updated: December 26, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014