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Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine,Freeze-dried

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.
 
ClinicalTrials.gov Identifier: NCT02560272
Recruitment Status : Unknown
Verified September 2015 by Beijing Minhai Biotechnology Co., Ltd.
Recruitment status was:  Recruiting
First Posted : September 25, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Beijing Minhai Biotechnology Co., Ltd

Brief Summary:
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.

Condition or disease Intervention/treatment Phase
Haemophilus Influenzae Type b Infections Biological: Minhai-HIB Biological: Act-HIB® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age
Study Start Date : September 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minhai-HIB
Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.
Biological: Minhai-HIB
0.5ml, intramuscular

Active Comparator: Act-HIB®
Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.
Biological: Act-HIB®
0.5ml, intramuscular




Primary Outcome Measures :
  1. Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL [ Time Frame: 28 days after last dose of primary vaccination ]

Secondary Outcome Measures :
  1. Number of Subjects With Any Solicited Local and General Symptoms [ Time Frame: Within 7 days after any vaccination ]
  2. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within 28 days after any vaccination ]
  3. Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations [ Time Frame: 28 days after last dose of primary vaccination ]


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 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy permanent residence 2 months to 5 years old.
  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
  • Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

  • History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
  • Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
  • Receipt of blood or blood-derived products in the 3 months preceding vaccination
  • Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
  • Receipt of any live virus vaccine in the 15 days preceding vaccination.
  • Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
  • Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
  • Thrombocytopenia.
  • History of treatment for thyroid gland disease.
  • Functional or anatomic asplenia.
  • History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Any condition that, in the judgment of investigator, may affect trial assessment.

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 ClinicalTrials.gov identifier (NCT number): NCT02560272


Contacts
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Contact: Guifan Li 86-10-59613591 guifan@sohu.com

Locations
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China, Henan
Henan Provincial Center for Disease Control and Prevention Recruiting
Zhengzhou, Henan, China
Contact: shengli xia    86-371-68089128    xiasl@hncdc.com.cn   
Sponsors and Collaborators
Beijing Minhai Biotechnology Co., Ltd
Investigators
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Principal Investigator: shengli xia Henan Provincial Center for Disease Control and Prevention
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Responsible Party: Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT02560272    
Other Study ID Numbers: 2014L00216
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Keywords provided by Beijing Minhai Biotechnology Co., Ltd:
vaccine
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