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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 4
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: rotavirus
vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months
|
3ml/dose, oral
|
|
Komparátor placeba: measles-rubella
vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months.
|
0.5ml per dose, subcutaneous injection
Ostatní jména:
|
|
Komparátor placeba: 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
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
the occurrence rate of general reaction of different vaccination groups
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
the occurrence rate of severe adverse event of different vaccination groups
Časové okno: 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
Časové okno: 1 month after vaccination
|
this measure is used to assess the immunogenicity of different groups
|
1 month after vaccination
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: rui ao, Master, Sichuan Provincial Center for Disease Control and Prevention
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- cnbg-001
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