Immunogenicity of Rotavirus Vaccine

Phase 4

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: Biological: Rotavirus vaccine

• Registration Number: NCT01199874
• Lead Sponsor: PATH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-13
• Study Start: 2011-04
• Primary Completion: 2012-09
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary 1: Rotavirus vaccine 6 and 10 weeks	Rotavirus vaccine	EPI vaccines + rotavirus vaccine at 6 and 10 weeks
Primary 1: Rotavirus vaccine 6, 10 and 14 weeks	Rotavirus vaccine	EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks
Primary 1: Rotavirus vaccine 10 and 14 weeks	Rotavirus vaccine	EPI vaccines + rotavirus vaccine at 10 and 14 weeks
Primary 2: Rotavirus vaccine withholding breast feeding	Rotavirus vaccine	EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding
Primary 2: Rotavirus vaccine with immediate breast feeding	Rotavirus vaccine	EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding

Primary Outcome Measures

Name	Time	Method
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml	6, 10, 14 and 18 weeks

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Pakistan