Haemophilus Influenzae Type b Infections Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 1560 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 2 Months to 5 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Henan Provincial Center for Disease Control and Prevention | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 28 days after last dose of primary vaccination | No | |
| Secondary | Number of Subjects With Any Solicited Local and General Symptoms | Within 7 days after any vaccination | Yes | |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 28 days after any vaccination | Yes | |
| Secondary | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 28 days after last dose of primary vaccination | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00359983 -
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
|
Phase 3 |