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OpenTrials
Completed

NCT Number: NCT02003495

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.

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Key information

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy permanent residence 2 months to 6 years old.
  • Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
  • Axillary temperature ≤37.0 ℃.

Exclusion criteria

  • History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
  • Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
  • Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
  • 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 thyroid gland excision or treatment for thyroid gland disease in last 12 months.
  • Functional or anatomic asplenia.
  • History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
  • Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
  • Any condition that, in the judgment of investigator, may affect trial assessment.

Treatment and study plan

MCV-ACYW135 Vaccine Group

Biological

0.5ml, intramuscular

Other names: Meningococcal ( A, C, Y and W 135) conjugate vaccine

MPV-ACYW135 Vaccine Group

Biological

0.5ml, intramuscular

Other names: Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine

MPV-A Vaccine Group

Biological

0.5ml, intramuscular

Other names: Group A Meningococcal Polysaccharide vaccine

MCV-AC Vaccine Group

Biological

0.5ml, intramuscular

Other names: Group A and C Meningococcal conjugate vaccine

Hib Vaccine Group

Biological

0.5ml, intramuscular

Other names: Haemophilus Influenzae Type b Conjugate Vaccine

Primary outcomes

  1. Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination

    Time frame: 28 days after vaccination

Secondary outcomes

  1. to evaluate the adverse reactions after vaccination

    Time frame: Within 28 days after vaccination

Sponsors and collaborators

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd

Industry

Registry information

Official study title

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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