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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02560272

Enrollment

1560

Registered

2015-09-25

Start date

2014-09-30

Completion date

2016-06-30

Last updated

2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Influenzae Type b Infections

Keywords

vaccine, haemophilus influenzae type b

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.

Interventions

BIOLOGICALMinhai-HIB

0.5ml, intramuscular

BIOLOGICALAct-HIB®

0.5ml, intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Months to 5 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Number of Subjects With Any Solicited Local and General Symptoms	Within 7 days after any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)	Within 28 days after any vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations	28 days after last dose of primary vaccination

Countries

China

Contacts

Primary ContactGuifan Li

guifan@sohu.com86-10-59613591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026