Immunogenicity of Rotavirus Vaccine

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

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:

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

• 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

Arms and Interventions

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

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Locations

Pakistan

Aga Khan University

Karachi, Pakistan

Sponsors and Collaborators

PATH

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: PATH
• ClinicalTrials.gov Identifier: NCT01199874
• Other Study ID Numbers: PATH HS534
• First Posted: September 13, 2010
• 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