NCT01199874

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,140

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

September 9, 2010

Last Update Submit

August 28, 2013

Conditions

Rotavirus Gastroenteritis

Keywords

RotavirusRotavirus vaccineDosing scheduleImmunogenicityBreast feedingPakistan

Outcome Measures

Primary Outcomes (1)

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

    6, 10, 14 and 18 weeks

Study Arms (6)

Primary 1: Rotavirus vaccine 6 and 10 weeks

ACTIVE COMPARATOR

EPI vaccines + rotavirus vaccine at 6 and 10 weeks

Biological: Rotavirus vaccine

Primary 1: Rotavirus vaccine 6, 10 and 14 weeks

EXPERIMENTAL

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

Biological: Rotavirus vaccine

Primary 1: Rotavirus vaccine 10 and 14 weeks

EXPERIMENTAL

EPI vaccines + rotavirus vaccine at 10 and 14 weeks

Biological: Rotavirus vaccine

Primary 2: Rotavirus vaccine withholding breast feeding

EXPERIMENTAL

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

Biological: Rotavirus vaccine

Primary 2: Rotavirus vaccine with immediate breast feeding

EXPERIMENTAL

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

Biological: Rotavirus vaccine

Baseline seroconversion for rotavirus

NO INTERVENTION

EPI vaccines

Interventions

Rotavirus vaccineBIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Also known as: Rotarix
Primary 1: Rotavirus vaccine 10 and 14 weeksPrimary 1: Rotavirus vaccine 6 and 10 weeksPrimary 1: Rotavirus vaccine 6, 10 and 14 weeksPrimary 2: Rotavirus vaccine with immediate breast feedingPrimary 2: Rotavirus vaccine withholding breast feeding

Eligibility Criteria

Age6 Weeks - 18 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 26035743DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Rotavirus VaccinesRIX4414 vaccine

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • S. Asad Ali, MBBS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

April 1, 2011

Primary Completion

September 1, 2012

Study Completion

June 1, 2013

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

PA(1)