Prevention of Pneumonia in Children (age: 6 to 15 years) with HIV Infectio
Phase 4
- Conditions
- Health Condition 1: null- This study group consists of HIV positive Children in the age group (6-15 Years of age)
- Registration Number
- CTRI/2013/04/003535
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Children 6-15 years of age known to have HIV infection with normal to moderate immune suppression who have not had the Hib or pneumococcal conjugate vaccine
2.Adult household member of child vaccinee
3.Sibling of child vaccinee
Exclusion Criteria
1. Hospitalized children,
2. Child who presents with an acute illness on study day requiring hospitalization or inpatient short stay observation will be excluded.
3. Children with severe immune suppression
4. Children with an acute febrile illness with fever over 38 degrees Celsius will be excluded for vaccine on that study day.
5. Known previous immunization with HibCV or PCV.
6. Known contraindication to HibCV or PCV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Nasopharyngeal carriage rate of Hib and Pneumococcus for all vaccine recipients, adult household member and sibling living with vaccine recipient <br/ ><br>2.Serotypes of pneumococcus isolated <br/ ><br>3. Reported adverse events to vaccine recipientsTimepoint: All outcomes will be evaluated at 0, 2, 4, 6, 8, 10, 12 months after the 1st Visit (which is expected to be same as day of 1st dose of vaccines. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Immune response to the Hib Conjugate Vaccine based on ELISA <br/ ><br>2. Antibiotic susceptibility of Hib and Pneumococcal isolates <br/ ><br>3. Carriage rates of other co-colonizers in the nasopharynx specifically S. aureusTimepoint: All outcomes will be evaluated at 0, 2, 4, 6, 8, 10, 12 months after the 1st Visit (which is expected to be same as day of 1st dose of vaccines). <br/ ><br>