Immunogenicity of Rotavirus Vaccine - Full Text View

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:

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	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Rotavirus vaccine	Phase 4


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:

MedlinePlus related topics: Breastfeeding Gastroenteritis

U.S. FDA Resources

Further study details as provided by PATH:

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 ]


Enrollment:	1140
Study Start Date:	April 2011
Study Completion Date:	June 2013
Primary Completion Date:	September 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Pakistan
Aga Khan University
Karachi, Pakistan

Sponsors and Collaborators

PATH

Investigators


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

More Information

No publications provided


Responsible Party:	PATH
ClinicalTrials.gov Identifier:	NCT01199874 History of Changes
Other Study ID Numbers:	PATH HS534
Study First Received:	September 9, 2010
Last Updated:	August 28, 2013
Health Authority:	United States: PATH

Keywords provided by PATH:


Rotavirus Rotavirus vaccine Dosing schedule	Immunogenicity Breast feeding Pakistan

Additional relevant MeSH terms:


Gastroenteritis Digestive System Diseases Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 25, 2015