A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

Haemophilus Influenza Clinical Trial

Official title:

A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692859
• Other study ID #: PRO-201301
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2016
• Last updated: August 22, 2017
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2017
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.

Description:

Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1992
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:

• Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group

• Without vaccination history of Hib conjugate vaccine

• One of his/her guardians is able to understand and sign the informed consent

• Subjects' guardian can and will comply with the requirements of the protocol

• Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

• Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease

• Subject who is allergic to any ingredient of the vaccines

• Subject with damaged or low immune function which has already been known

• Subject who had a Hib disease medical history

• Subject with acute febrile illness or infectious disease

• Major congenital defects, developmental disorders or serious chronic illness

• Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection

• Subject who has serious allergic history

• Subject with other medical history not suitable for vaccination such as difficulty for blood collection

• Any prior administration of immunodepressant or corticosteroids in last 6 months

• Any prior administration of blood products in last 3 months

• Any prior administration of other research medicine/vaccine in last 30 days

• Any prior administration of any attenuated live vaccine in last 14 days

• Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine

• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or his/her guardian's signature on informed consent

Related Conditions & MeSH terms

• Haemophilus Infections
• Haemophilus Influenza
• Influenza, Human

Intervention

Biological:
• Hib conjugate vaccine
Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Chengdu Olymvax Biopharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Solicited Adverse Reactions	Number of Participants with Solicited Adverse Reactions	0-7 days after each dose
Primary	Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations =1.0µg/ml		28 days after full course of vaccination
Secondary	Incidence of Unsolicited Adverse Reactions		0-28 days after each dose
Secondary	Incidence of Serious Adverse Event (SAE) During the Whole Study Period		0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y
Secondary	Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations =0.15µg/ml		28 days after full course of vaccination
Secondary	the Anti-PRP Geometric Mean Concentrations (GMCs)		28 days after full course of vaccination
Secondary	the Anti-PRP Geometric Mean Fold Increase (GMFI)		28 days after full course of vaccination