NCT00280111

Brief Summary

It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is the basis for developing a vaccine since it suggests that the first infection immunizes the child against disease upon re-infection. It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year. Both these strains are well characterized and the safety studies have been done in animal models. These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens. These vaccines have therefore, also been tested in India.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
Last Updated

July 2, 2008

Status Verified

July 1, 2008

Enrollment Period

4 months

First QC Date

January 13, 2006

Last Update Submit

July 1, 2008

Conditions

Rotavirus Infections

Keywords

rotavirusvaccinesafetyimmunogenicityinfants

Outcome Measures

Primary Outcomes (1)

  • - Safety

    4 weeks after test article administration

Secondary Outcomes (1)

  • - Vaccine Take, antibody titers in subjects in vaccine and placebo groups 28 days after administration of vaccine/placebo or shedding of rotavirus vaccine strains by antigen detection ELISA on days 3, 7 and 28 post administration.

    4 weeks post administration of test article

Study Arms (3)

1

EXPERIMENTAL

116E AGMK

Biological: 116E AGMK

2

EXPERIMENTAL

I321 AGMK

Drug: I321

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

116E AGMKBIOLOGICAL

Single dose of 116E 10\^5 FFu

1
I321DRUG

Single dose of I321 10\^5 FFu

2
PlaceboDRUG

1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine

3

Eligibility Criteria

Age8 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants
  • Consent available

You may not qualify if:

  • Evidence of renal, cardiovascular, liver or other reticuloendothelial, neurological, gastrointestinal, hematologic, rheumatologic or immunologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (1)

  • Bhandari N, Sharma P, Glass RI, Ray P, Greenberg H, Taneja S, Saksena M, Rao CD, Gentsch JR, Parashar U, Maldonado Y, Ward RL, Bhan MK. Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: results of a randomised controlled trial. Vaccine. 2006 Jul 26;24(31-32):5817-23. doi: 10.1016/j.vaccine.2006.05.001. Epub 2006 May 12.

    PMID: 16735085BACKGROUND

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Maharaj K Bhan, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Pratima Ray, PhD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 20, 2006

Study Start

January 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

July 2, 2008

Record last verified: 2008-07

Locations

IN(1)