A clinical trial to study the long term benefit of Serum Institute of Indiaâ??s Pneumococcal Conjugate Vaccine in Indian Toddlers.

A Phase 4, Cross-Sectional Study to Evaluate Pneumococcal Nasopharyngeal Carriage in Healthy Toddlers Following Vaccination With 10-Valent Pneumococcal Conjugate Vaccine (PNEUMOSILÂ®) as Part of Universal Immunization Program in India As Compared To Nonvaccinated Toddlers

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/11/047023

Enrollment

700

Registered

2022-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

None listed

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria (Vaccinated Arm) All the below-mentioned inclusion criteria will have to be fulfilled in order to be eligible for study participation in the vaccinated cohort: 1. Healthy children aged 15-20 months of age residing in the study area 2. Receipt of three doses of PNEUMOSILÂ® vaccine (2+1 regime) through universal immunization program 3. Parent(s) willing to provide a voluntary written informed consent for their childâ??s participation in the study Inclusion Criteria (Nonvaccinated Arm) All the below-mentioned inclusion criteria will have to be fulfilled in order to be eligible for study participation in the nonvaccinated arm: 1. Healthy PCV-naÃ¯ve children aged 16-21 months of age residing in the study area with non-receipt of PCV verified through vaccination cards 2. Parent(s) willing to provide a voluntary written informed consent for their childâ??s participation in the study

Exclusion criteria

Exclusion criteria: Exclusion Criteria (Vaccinated and Nonvaccinated Arms) A toddler will be ineligible for enrolment in the study if any of the following criteria are met during screening: 1. Presence of fever on the day of enrolment (>=38.0oC) (temporary exclusion) 2. History of acute respiratory tract infection in the past 7 days (temporary exclusion) 3. History of receipt of antibiotic in last 7 days (temporary exclusion) 4. Presence of acute or chronic, clinically significant nutritional, pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, endocrinological, musculoskeletal or hematological functional abnormality or illness that requires medical therapy. 5. History of any known chronic medical or surgical condition that affect the study outcomes 6. Any medical or social condition that in the opinion of the PI may interfere with the study objectives or pose a risk to the participant.

Design outcomes

Primary

Measure	Time frame
Percentage of study participants with nasopharyngeal carriage of at least one VT of S. pneumoniae included in PNEUMOSILÂ® at 15-21 months of age.Timepoint: NP Swab at 15-21 months of age.	—

Secondary

Measure	Time frame
Percentage of study participants with nasopharyngeal carriage of at least one serotype of S. pneumoniae at the age of 15 to 21 months of ageTimepoint: NP Swab at 15-21 months of age.	—

Countries

India

Contacts

Public ContactDr Vistasp Sethna

Serum Institute of India Pvt. Ltd. (SIIPL)

vistasp.sethna@seruminstitute.com02026602506

Outcome results