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Immunogenicity of Rotavirus Vaccine

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ClinicalTrials.gov Identifier: NCT01199874
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
PATH

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Rotavirus Gastroenteritis Biological: Rotavirus vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml [ Time Frame: 6, 10, 14 and 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 18 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199874


Locations
Pakistan
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: S. Asad Ali, MBBS Aga Khan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01199874     History of Changes
Other Study ID Numbers: PATH HS534
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013

Keywords provided by PATH:
Rotavirus
Rotavirus vaccine
Dosing schedule
 Immunogenicity
Breast feeding
Pakistan

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs