Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

Diarrhea Clinical Trial

— Rotavin-M1  

Official title:

A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502969
• Other study ID #: Rotavin-M1-2b
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 29, 2011
• Last updated: December 30, 2011
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.

Description:

The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.

This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

At study entry

1. A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).

2. Full term gestation (>=37 weeks).

3. Birth weight of the subject should be >=2.5 kg.

4. Healthy subjects as established by medical history and clinical examination before entering into the study.

5. Did not use any dose of Rota virus vaccine.

6. Written informed consent obtained from the parent or guardian of the subject.

At dose 2

1. Received dose 1.

2. Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

Exclusion Criteria:

At study entry

1. Has a chronic disease (cardiovascular, liver, kidney disease).

2. Acute disease at the time of enrolment.

3. Administering corticosteroids (> 1mg/kg/day).

4. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).

5. Immunosuppressive or immunodeficient condition.

6. Family has immunosuppressive or immunodeficient condition medical history.

7. History of high fever convulsion.

8. Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.

9. Preterm of gestation delivery (gestation period < 37 weeks).

10. Low birth weight (<2.5 kg).

11. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.

12. Malnutrition.

13. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.

14. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

At dose 2

1. Acute disease at the time of 2nd dose.

2. Administering corticosteroids (> 1mg/kg/day).

3. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).

4. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.

5. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.

6. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.

7. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Fever
• Irritability
• Nausea
• Vomit

Intervention

Biological:
• Rotavin-M1
liquid, 10e6ffu/dose, 2 doses, 2 month interval
• cell culture medium in absence of virus
Placebo

Locations

Country	Name	City	State
Vietnam	Thai Binh Preventive Medicine Center	Thai Binh
Vietnam	Preventive Medicine Center	Thanh Son	Phu Tho

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (6)

Anh DD, Thiem VD, Fischer TK, Canh DG, Minh TT, Tho le H, Van Man N, Luan le T, Kilgore P, von Seidlein L, Glass RI. The burden of rotavirus diarrhea in Khanh Hoa Province, Vietnam: baseline assessment for a rotavirus vaccine trial. Pediatr Infect Dis J. 2006 Jan;25(1):37-40. — View Citation

Kim SY, Goldie SJ, Salomon JA. Cost-effectiveness of Rotavirus vaccination in Vietnam. BMC Public Health. 2009 Jan 21;9:29. doi: 10.1186/1471-2458-9-29. — View Citation

Luan le T, Trang NV, Phuong NM, Nguyen HT, Ngo HT, Nguyen HT, Tran HB, Dang HN, Dang AD, Gentsch JR, Wang Y, Esona MD, Glass RI, Steele AD, Kilgore PE, Nguyen MV, Jiang B, Nguyen HD. Development and characterization of candidate rotavirus vaccine strains derived from children with diarrhoea in Vietnam. Vaccine. 2009 Nov 20;27 Suppl 5:F130-8. doi: 10.1016/j.vaccine.2009.08.086. — View Citation

Ngo TC, Nguyen BM, Dang DA, Nguyen HT, Nguyen TT, Tran VN, Vu TT, Ogino M, Alam MM, Nakagomi T, Nakagomi O, Yamashiro T. Molecular epidemiology of rotavirus diarrhoea among children in Haiphong, Vietnam: the emergence of G3 rotavirus. Vaccine. 2009 Nov 20;27 Suppl 5:F75-80. doi: 10.1016/j.vaccine.2009.08.074. — View Citation

Nguyen TA, Yagyu F, Okame M, Phan TG, Trinh QD, Yan H, Hoang KT, Cao AT, Le Hoang P, Okitsu S, Ushijima H. Diversity of viruses associated with acute gastroenteritis in children hospitalized with diarrhea in Ho Chi Minh City, Vietnam. J Med Virol. 2007 May;79(5):582-90. — View Citation

Van Man N, Luan le T, Trach DD, Thanh NT, Van Tu P, Long NT, Anh DD, Fischer TK, Ivanoff B, Gentsch JR, Glass RI; Vietnam Rotavirus Surveillance Network. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998-2003. J Infect Dis. 2005 Sep 1;192 Suppl 1:S127-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-rotavirus IgA antibody responses 1 month after vaccination	To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose	12 months	Yes
Secondary	RV-IgA antibody responses to Rotavin-M1 one year after 1st dose	to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)	12 year	Yes
Secondary	Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1	to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1	12 months	Yes
Secondary	safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose	to assess immediate reations (30 minutes) after administration of each dose of vaccine compared to placebo . To assess adverse events 30 days after each dose of vaccine and placebo, and serious adverse events 1 year after the 1st dose of vaccine and placebo	12 months	Yes
Secondary	anti-RV IgG antibody responses 1 year after the 1st dose	To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)	12 month	Yes