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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary 1: Rotavirus vaccine 6 and 10 weeks | Active Comparator | EPI vaccines + rotavirus vaccine at 6 and 10 weeks |
|
| Primary 1: Rotavirus vaccine 6, 10 and 14 weeks | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks |
|
| Primary 1: Rotavirus vaccine 10 and 14 weeks | Experimental | EPI vaccines + rotavirus vaccine at 10 and 14 weeks |
|
| Primary 2: Rotavirus vaccine withholding breast feeding | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding |
|
| Primary 2: Rotavirus vaccine with immediate breast feeding | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding |
|
| Baseline seroconversion for rotavirus |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus vaccine | Biological | live attenuated oral rotavirus vaccine; lyophilized; 1 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml | 6, 10, 14 and 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. Asad Ali, MBBS | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26035743 | Derived | 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. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| C492457 | RIX4414 vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| No Intervention |
EPI vaccines |
|