Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam (Other)

Overall Status

Completed

CT.gov ID

NCT01502969

Collaborator

(none)

799

Enrollment

Locations

Arms

Duration (Months)

399.5

Patients Per Site

23.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea Fever Nausea Vomit Irritability	Biological: Rotavin-M1 Biological: cell culture medium in absence of virus	Phase 2/Phase 3

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

799 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Children receiving placebo (cell culture medium in absence of virus)	Biological: cell culture medium in absence of virus Placebo
Active Comparator: Rotavirus vaccine Rotavin-M1, 10e6.3ffu/dose, 2 doses	Biological: Rotavin-M1 liquid, 10e6ffu/dose, 2 doses, 2 month interval Other Names: KH0118 POLYVAC G1P[8]

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Children receiving placebo (cell culture medium in absence of virus)

Biological: cell culture medium in absence of virus

Placebo

Active Comparator: Rotavirus vaccine

Rotavin-M1, 10e6.3ffu/dose, 2 doses

Biological: Rotavin-M1

liquid, 10e6ffu/dose, 2 doses, 2 month interval

Other Names:

KH0118

POLYVAC

G1P[8]

Outcome Measures

Primary Outcome Measures

Anti-rotavirus IgA antibody responses 1 month after vaccination [12 months]
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose

Secondary Outcome Measures

RV-IgA antibody responses to Rotavin-M1 one year after 1st dose [12 year]
to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)
Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1 [12 months]
to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1
safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose [12 months]
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
anti-RV IgG antibody responses 1 year after the 1st dose [12 month]
To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

At study entry

A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
Full term gestation (>=37 weeks).
Birth weight of the subject should be >=2.5 kg.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Did not use any dose of Rota virus vaccine.
Written informed consent obtained from the parent or guardian of the subject.

At dose 2

Received dose 1.
Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

Exclusion Criteria:

At study entry

Has a chronic disease (cardiovascular, liver, kidney disease).
Acute disease at the time of enrolment.
Administering corticosteroids (> 1mg/kg/day).
Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
Immunosuppressive or immunodeficient condition.
Family has immunosuppressive or immunodeficient condition medical history.
History of high fever convulsion.
Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
Preterm of gestation delivery (gestation period < 37 weeks).
Low birth weight (<2.5 kg).
Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
Malnutrition.
Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
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

Acute disease at the time of 2nd dose.
Administering corticosteroids (> 1mg/kg/day).
Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.