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

Study for Safety , immunogenicity and efficacy of intramuscular administration of Haemophilus Influenzae type b conjugate vaccine manufactured by Masoondarou Co. (MAS-HibVAC®) in 50 children and compare with foreign sample

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201008084536N1

Enrollment

Registered

2012-03-05

Start date

2012-04-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Children Haemophilus Meningitis. Meningitis due to Haemophilus influenzae

Interventions

Intervention 1: interment 2 Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by Novartis. Intervention 2: Interment 1 is Hib polysaccharide – tetanus toxoid conjugate vaccine manuf

Prevention

interment 2 Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by Novartis

Interment 1 is Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by MASOONDAROU Co. (MAS-HibVAC®)

Eligibility

Sex/Gender

All

Age

1 Years to 1 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZolfagharian H

Masoondarou Co.

zolfagharianh@yahoo.com+98 26 1667 0350

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026