Skip to content

Prevention of Pneumonia in Children (age: 2 to 5 years) with HIV Infection.

Prevention of Pneumonia in Children (age: 2 to 5 years) with HIV Infection - PPH-1

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/03/002515
Enrollment
300
Registered
2012-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- This study group consists of HIV positive Children in the age group (2-5 Years of age)

Interventions

Intervention1: Vaccines used : Pneumococcal Conjugate Vaccine (PCV-13 manufactured by Wyeth) and Hib Conjugate Vaccine (HibCV , manufactured by Serum Institute -India) : Schedule : â?¢ Two doses of

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children 2-5 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.HIV negative children of 2-5 years of age who have not had the pneumococcal or Hib conjugate vaccines 3.Adult household member of child vaccinee 4.Sibling of child vaccinee

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1.Nasopharyngeal carriage rate of Hib and Pneumococcus for all vaccine recipients, adult household member and sibling living with vaccine recipient 2.Serotypes of pneumococcus isolated 3. Reported adverse events to vaccine recipients Timepoint: Measured at baseline and at two month intervals in HIV infected children, HIV uninfected controls, their siblings and parents, for a follow-up time of one year since study entry.

Secondary

MeasureTime frame
1. Immune response to the HibCV and PCV based on ELISA 2. Antibiotic susceptibility of Hib and Pneumococcal isolates 3. Carriage rates of other co-colonizers in the nasopharynx specifically S. aureus Timepoint: Measured at baseline and at two month intervals in HIV infected children, HIV uninfected controls, their siblings and parents, for a follow-up time of one year since study entry.

Countries

India

Contacts

Public ContactDr Subhashish Bhattacharya

School of Medical Science and Technology , Indian Institute of Technology â??Kharagpur

bikasarya.mm@iitkgp.ac.in03222283576

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026