Immunogenicity of Rotavirus Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01199874
First received: September 9, 2010
Last updated: August 28, 2013
Last verified: August 2013

September 9, 2010
August 28, 2013
April 2011
September 2012   (final data collection date for primary outcome measure)
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml [ Time Frame: 6, 10, 14 and 18 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01199874 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Immunogenicity of Rotavirus Vaccine
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Rotavirus Gastroenteritis
Biological: Rotavirus vaccine
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Other Name: Rotarix
  • Active Comparator: Primary 1: Rotavirus vaccine 6 and 10 weeks
    EPI vaccines + rotavirus vaccine at 6 and 10 weeks
    Intervention: Biological: Rotavirus vaccine
  • Experimental: Primary 1: Rotavirus vaccine 6, 10 and 14 weeks
    EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks
    Intervention: Biological: Rotavirus vaccine
  • Experimental: Primary 1: Rotavirus vaccine 10 and 14 weeks
    EPI vaccines + rotavirus vaccine at 10 and 14 weeks
    Intervention: Biological: Rotavirus vaccine
  • Experimental: Primary 2: Rotavirus vaccine withholding breast feeding
    EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding
    Intervention: Biological: Rotavirus vaccine
  • Experimental: Primary 2: Rotavirus vaccine with immediate breast feeding
    EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding
    Intervention: Biological: Rotavirus vaccine
  • No Intervention: Baseline seroconversion for rotavirus
    EPI vaccines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1140
June 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 18 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01199874
PATH HS534
No
PATH
PATH
Not Provided
Principal Investigator: S. Asad Ali, MBBS Aga Khan University
PATH
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP