Clinical trial NCT02560272: Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b Infections
Keywords: vaccine
haemophilus influenzae type b
Lead sponsor: Beijing Minhai Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 1560
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 28 days after last dose of primary vaccination
Secondary outcomes:
measure: Number of Subjects With Any Solicited Local and General Symptoms
timeFrame: Within 7 days after any vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Within 28 days after any vaccination
measure: Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
timeFrame: 28 days after last dose of primary vaccination
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: shengli xia
role: PRINCIPAL_INVESTIGATOR
References: