Immunogenicity of Rotavirus Vaccine

August 28, 2013 updated by: PATH

The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine

Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:

  1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
  2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
  • Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
  • Written informed consent obtained from the parents or guardians.

Exclusion Criteria:

  • Hypersensitivity to any of the vaccine components.
  • Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
  • Use of any immunosuppressive drugs.
  • Previous intussusception or abdominal surgery.
  • Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
  • Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
  • Immunoglobulin and/or blood products use since birth or during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Primary 1: Rotavirus vaccine 6 and 10 weeks
EPI vaccines + rotavirus vaccine at 6 and 10 weeks
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Names:
  • Rotarix
EXPERIMENTAL: Primary 1: Rotavirus vaccine 6, 10 and 14 weeks
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Names:
  • Rotarix
EXPERIMENTAL: Primary 1: Rotavirus vaccine 10 and 14 weeks
EPI vaccines + rotavirus vaccine at 10 and 14 weeks
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Names:
  • Rotarix
EXPERIMENTAL: Primary 2: Rotavirus vaccine withholding breast feeding
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Names:
  • Rotarix
EXPERIMENTAL: Primary 2: Rotavirus vaccine with immediate breast feeding
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Names:
  • Rotarix
NO_INTERVENTION: Baseline seroconversion for rotavirus
EPI vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
Time Frame: 6, 10, 14 and 18 weeks
6, 10, 14 and 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PATH

Investigators

  • Principal Investigator: S. Asad Ali, MBBS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (ESTIMATE)

September 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATH HS534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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