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Immunogenicity of Rotavirus Vaccine

NCT ID: NCT01199874

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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:

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

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Conditions

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Rotavirus Gastroenteritis

Keywords

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Rotavirus Rotavirus vaccine Dosing schedule Immunogenicity Breast feeding Pakistan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Primary 1: Rotavirus vaccine 6 and 10 weeks

EPI vaccines + rotavirus vaccine at 6 and 10 weeks

Group Type ACTIVE_COMPARATOR

Rotavirus vaccine

Intervention Type BIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Primary 1: Rotavirus vaccine 6, 10 and 14 weeks

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

Group Type EXPERIMENTAL

Rotavirus vaccine

Intervention Type BIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Primary 1: Rotavirus vaccine 10 and 14 weeks

EPI vaccines + rotavirus vaccine at 10 and 14 weeks

Group Type EXPERIMENTAL

Rotavirus vaccine

Intervention Type BIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Primary 2: Rotavirus vaccine withholding breast feeding

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

Group Type EXPERIMENTAL

Rotavirus vaccine

Intervention Type BIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Primary 2: Rotavirus vaccine with immediate breast feeding

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

Group Type EXPERIMENTAL

Rotavirus vaccine

Intervention Type BIOLOGICAL

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Baseline seroconversion for rotavirus

EPI vaccines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rotavirus vaccine

live attenuated oral rotavirus vaccine; lyophilized; 1 ml

Intervention Type BIOLOGICAL

Other Intervention Names

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Rotarix

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PATH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Asad Ali, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 26035743 (View on PubMed)

Other Identifiers

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PATH HS534

Identifier Type: -

Identifier Source: org_study_id