The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study.
The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.
調査の概要
状態
条件
詳細な説明
Quality control plan:
- All vaccinators should get professional training held by local Health Bureau, and be qualified by local Health Bureau.
- All the clinical trial related staffs are trained by provincial or prefectural Center for Disease Control and prevention (CDC) at the beginning.
- Provincial and prefectural CDCs conduct supervision at each step, especially during field vaccination and Adverse Events Following Immunization (AEFI) investigation.
- Data valid check is designed to work in the database inputting, double entry and validation is also required.
- The field works are conduct under SOP (Standard Operating Procedures), The SOP for vaccination procedures which include vaccinee recruitment and vaccination practice etc. is 'Immunization Work Specification' issued by China Ministry of Health in 2005. The SOP for AEFI surveillance is 'AEFI surveillance guideline' issued by China Ministry of Health in 2010.
Statistical plan
- Safety evaluation The analytic data include all reactions or events within 30 days after vaccination, compare the incidence of reactions among different vaccines, the statistical method is chi-square.
- Immunogenicity evaluation Compare the antibody positive rate and Geometric Mean Concentration between pre-vaccination and post-vaccination, and among different vaccine combinations.
safety evaluation method
At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, >38.5°C), angioedema, or a local injection-site reaction (diameter, >2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.
- Immunogenicity evaluation
Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.
研究の種類
入学 (予想される)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 8~9 months healthy child
- Subjects or guardians who can and will comply with the requirements of the protocol
- Without vaccination history of rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine.
- Axillary temperature is under 37.0℃.
- Accord with the requirement of drug manual of rotavirus vaccine,measles-rubella vaccine and measles-mumps-rubella vaccine.
Exclusion Criteria:
- Allergic to any component of the vaccines.
- Women of pregnancy, lactation or about to be pregnant in 60 days.
- Infected by some rash disease within one month.
- Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
- Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 4 weeks.
- Family history of seizures or progressive neurological disease.
- Diarrheal caused by rotavirus or lasting for 3 or more days.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：rotavirus
vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months
|
3ml/dose, oral
|
|
プラセボコンパレーター：measles-rubella
vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months.
|
0.5ml per dose, subcutaneous injection
他の名前：
|
|
プラセボコンパレーター：measles-mumps-rubella
vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months.
|
0.5ml per dose, subcutaneous injection
他の名前：
|
|
実験的：rotavirus, measles-rubella
simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8~9 months.
|
3ml/dose, oral
0.5ml per dose, subcutaneous injection
他の名前：
|
|
実験的：rotavirus, measles-mumps-rubella
simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8~9 months.
|
3ml/dose, oral
0.5ml per dose, subcutaneous injection
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the occurrence rate of general reaction of different vaccination groups
時間枠：1 months after vaccination
|
general reaction includes fever (axillary temperature> 3.85℃), local injection-site reaction (diameter> 2.5 cm) etc.
|
1 months after vaccination
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the occurrence rate of severe adverse event of different vaccination groups
時間枠：1 month after vaccination
|
severe reaction include: anaphylaxis, angioedema, purpura, an Arthus reaction, febrile convulsion, seizure, polyneuritis, other adverse events cause fatal, result in disability or clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine)
|
1 month after vaccination
|
|
The variation of antibody Geometric Mean Titer compared between before and after vaccination
時間枠：1 month after vaccination
|
this measure is used to assess the immunogenicity of different groups
|
1 month after vaccination
|
協力者と研究者
捜査官
- スタディディレクター：rui ao, Master、Sichuan Provincial Center for Disease Control and Prevention
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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