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

NCT02692859 | Completed Phase 3 Results

• 1 other identifier: PRO-201301
• Study Type: interventional
• Target: 1,992
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Haemophilus Influenza

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Solicited Adverse Reactions

  Number of Participants with Solicited Adverse Reactions

  0-7 days after each dose

• Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml

  28 days after full course of vaccination

Secondary Outcomes (5)

• Incidence of Unsolicited Adverse Reactions

  0-28 days after each dose

• 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

• Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml

  28 days after full course of vaccination

• the Anti-PRP Geometric Mean Concentrations (GMCs)

  28 days after full course of vaccination

• the Anti-PRP Geometric Mean Fold Increase (GMFI)

  28 days after full course of vaccination

Study Arms (2)

Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)

EXPERIMENTAL

Hib conjugate vaccine

Biological: Hib conjugate vaccine

Vaccine (Walvax Biotechnology Co., LTD.)

ACTIVE COMPARATOR

Hib conjugate vaccine

Biological: Hib conjugate vaccine

Interventions

Hib conjugate vaccine BIOLOGICAL

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

Vaccine (Walvax Biotechnology Co., LTD.); Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Chengdu Olymvax Biopharmaceuticals Inc.: collaborator

Results Point of Contact

• Title: Kai Chu
• Organization: jiangsuPCDCP

chukai19812007@163.com

18915999781

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 26, 2016
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 20, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share