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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Haemophilus Influenzae Type b Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Minhai-HIB

Intervention Type BIOLOGICAL

0.5ml, intramuscular

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.

Group Type ACTIVE_COMPARATOR

Act-HIB®

Intervention Type BIOLOGICAL

0.5ml, intramuscular

Interventions

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Minhai-HIB

0.5ml, intramuscular

Intervention Type BIOLOGICAL

Act-HIB®

0.5ml, intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes