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Immunogenicity of Rotavirus Vaccine

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Rotavirus vaccine
Sponsored by
PATH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis focused on measuring Rotavirus, Rotavirus vaccine, Dosing schedule, Immunogenicity, Breast feeding, Pakistan

Eligibility Criteria

6 Weeks - 18 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Primary 1: Rotavirus vaccine 6 and 10 weeks

Primary 1: Rotavirus vaccine 6, 10 and 14 weeks

Primary 1: Rotavirus vaccine 10 and 14 weeks

Primary 2: Rotavirus vaccine withholding breast feeding

Primary 2: Rotavirus vaccine with immediate breast feeding

Baseline seroconversion for rotavirus

Arm Description

EPI vaccines + rotavirus vaccine at 6 and 10 weeks

EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks

EPI vaccines + rotavirus vaccine at 10 and 14 weeks

EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding

EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding

EPI vaccines

Outcomes

Primary Outcome Measures

Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml

Secondary Outcome Measures

Full Information

First Posted
September 9, 2010
Last Updated
August 28, 2013
Sponsor
PATH
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1. Study Identification

Unique Protocol Identification Number
NCT01199874
Brief Title
Immunogenicity of Rotavirus Vaccine
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis
Keywords
Rotavirus, Rotavirus vaccine, Dosing schedule, Immunogenicity, Breast feeding, Pakistan

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary 1: Rotavirus vaccine 6 and 10 weeks
Arm Type
Active Comparator
Arm Description
EPI vaccines + rotavirus vaccine at 6 and 10 weeks
Arm Title
Primary 1: Rotavirus vaccine 6, 10 and 14 weeks
Arm Type
Experimental
Arm Description
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks
Arm Title
Primary 1: Rotavirus vaccine 10 and 14 weeks
Arm Type
Experimental
Arm Description
EPI vaccines + rotavirus vaccine at 10 and 14 weeks
Arm Title
Primary 2: Rotavirus vaccine withholding breast feeding
Arm Type
Experimental
Arm Description
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding
Arm Title
Primary 2: Rotavirus vaccine with immediate breast feeding
Arm Type
Experimental
Arm Description
EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding
Arm Title
Baseline seroconversion for rotavirus
Arm Type
No Intervention
Arm Description
EPI vaccines
Intervention Type
Biological
Intervention Name(s)
Rotavirus vaccine
Other Intervention Name(s)
Rotarix
Intervention Description
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
Primary Outcome Measure Information:
Title
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
Time Frame
6, 10, 14 and 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Asad Ali, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26035743
Citation
Ali A, Kazi AM, Cortese MM, Fleming JA, Moon S, Parashar UD, Jiang B, McNeal MM, Steele D, Bhutta Z, Zaidi AK. Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine--a randomized trial. PLoS One. 2015 Jun 2;10(6):e0127622. doi: 10.1371/journal.pone.0127622. eCollection 2015. Erratum In: PLoS One. 2015;10(12):e0145568.
Results Reference
derived

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Immunogenicity of Rotavirus Vaccine

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