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Immunogenicity of Rotavirus Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:
NCT01199874
First received: September 9, 2010
Last updated: October 2, 2012
Last verified: September 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Rotavirus Gastroenteritis
 Biological: Rotavirus vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Program for Appropriate Technology in Health:

Primary Outcome Measures:
  • Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml [ Time Frame: 6, 10, 14 and 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Rotarix
No Intervention: Baseline seroconversion for rotavirus
EPI vaccines

  Eligibility

Ages Eligible for Study:   6 Weeks to 18 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199874

Locations
Pakistan
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
Program for Appropriate Technology in Health
Investigators
Principal Investigator: S. Asad Ali, MBBS Aga Khan University
  More Information

No publications provided

Responsible Party: Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier: NCT01199874     History of Changes
Other Study ID Numbers: PATH HS534
Study First Received: September 9, 2010
Last Updated: October 2, 2012
Health Authority: United States: PATH

Keywords provided by Program for Appropriate Technology in Health:
Rotavirus
Rotavirus vaccine
Dosing schedule
 Immunogenicity
Breast feeding
Pakistan

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013