Study for effects of Haemophilus Influenzae type b conjugate vaccine in childre

Not Applicable

• Conditions: Children Haemophilus Meningitis.; Meningitis due to Haemophilus influenzae

• Registration Number: IRCT201008084536N1
• Lead Sponsor: Masoondarou Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria :
1-Male or females age 2-4 months.
2- Generally in good Health .
3- Written informed consent by the legal guardians.
4- No Known immunological deficiency, including HIV infection .
5- No known serious diseases, including diabetes , and epilepsy .
6- No involvement in other drug or vaccine clinical trials during the study period .
7- No current or foreseeable use of immunosupressors within 1 month prior to vaccination and during the period of study .
8- No known allergy to biological products .
9- No history of vaccination against Haemophilus Influenzae type b .
10- No fever at the time of vaccination ( oral body temperature > 37.5 C ) .
11- No known allergy to a vaccine component. Exclusion criteria :
1- Need for use of special drugs ( immunosupressores ,…………) during of the trial .
2- Withdrawal of consent by the legal guardians .
3- Evidence of any unusual condition in volunteer on the basis of trial medical team idea ( serious diseases , surgery , …………) .
4- Evidence of any serious diseases , including diabetes , and epilepsy .
5- Abnormal results of hematology and biochemistry tests such as lococytopenia , lococytosis , thrombocytopenia , anemia , hypercalemia , hypocalemia , hypernatremia , hyponatremia ,…….

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence any local and systemic adverse effects. Timepoint: 8th, 16th and 20th weeks. Method of measurement: Paraclinical assesment, clinical examination and Diary card reports.;Immunogenicity. Timepoint: At the Day 30 after the end of injection. Method of measurement: Elisa.;Efficacy. Timepoint: At Day 30 after the end of injection. Method of measurement: Bactricidal effect of serum of volunteers.

Secondary Outcome Measures

Name	Time	Method
Effects of vaccines on the functions of blood system. Timepoint: Before vaccine administration and 30 days after end vaccine injection. Method of measurement: Paraclinical tests.;Effects of vaccines on the functions of hepatic and renal system. Timepoint: Before vaccine administration and 30 days after end vaccine injection. Method of measurement: Paraclinical tests.;Effects of vaccines on the functions of nervous system. Timepoint: All of study duration. Method of measurement: Clinical examination.;Effects of vaccines on the functions of cardiac and respiratory systems . Timepoint: All of study duration. Method of measurement: Clinical examination.