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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00808392
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : December 29, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
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 or disease Intervention/treatment Phase
Haemophilus Influenzae Type b Biological: Haemophilus influenzae type b vaccine Biological: Commercial Haemophilus influenzae type b vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 916 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00808392

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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
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Responsible Party: Novartis Vaccines Identifier: NCT00808392    
Other Study ID Numbers: M37P2
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011
Keywords provided by Novartis ( Novartis Vaccines ):
haemophilus influenzae type b
Additional relevant MeSH terms:
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Haemophilus Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs