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
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rotavirus Gastroenteritis | Biological: Rotavirus vaccine | Phase 4 |
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 |

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

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Ages Eligible for Study: | 6 Weeks to 18 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Pakistan | |
Aga Khan University | |
Karachi, Pakistan |
Principal Investigator: | S. Asad Ali, MBBS | Aga Khan University |
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 |