| CTRI Number |
CTRI/2025/07/090122 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Seroprevalence of antibodies against various vaccine preventable diseases among the rural population of Maharashtra |
|
Scientific Title of Study
|
A cross-sectional study to assess levels of antibodies against Pentavalent, Measles-Rubella vaccine and Respiratory Syncytial Virus among the rural population of Maharashtra |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine
Bharati Vidyapeeth DU Medical College
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine
Bharati Vidyapeeth DU Medical College
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Palkar |
| Designation |
Professor Community Medicine |
| Affiliation |
Bharati Vidyapeeth DU Medical College Pune |
| Address |
Department of Community Medicine
Bharati Vidyapeeth DU Medical College
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA
411043
India |
| Phone |
9881008717 |
| Fax |
|
| Email |
palkarsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth DU Medical College
Pune Satara Road
Dhankawadi
Pune Maharashtra I
India
Pin code 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth DU Medical College |
| Address |
Pune Satara Road
Dhankawadi
Pune Maharashtra
India
Pin code 411043 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Palkar |
Bharati vidyapeeth DU Medical College Hospital And Research Center |
Clinical Research Unit
Bharati Vidyapeeth DU Medical College Hospital & Research Center
Pune Satara Road
Dhankawadi
Pune
MAHARASHTRA |
9881008717
palkarsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (Deemed to be University) Medical College Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Any child between 1 and 17 years of age and an adult residing in the study area |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anti-Measles antibodies in children aged 1-17 years and adults residing in rural areas |
Cross-sectional study, so it will be assessed at baseline (single visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| seroprevalence of antibodies against diphtheria, pertussis, tetanus, Hib, hepatitis B, rubella & RSV in children aged 1-15 years |
Cross-sectional study, so it will be assessed at the baseline visit |
|
|
Target Sample Size
|
Total Sample Size="900"
Sample Size from India="900"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [palkarsh@gmail.com].
- For how long will this data be available start date provided 01-08-2026 and end date provided 31-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
India has made significant strides in expanding immunisation coverage through the Universal Immunisation Programme (UIP). Since the launch of the Expanded Program of Immunisation in 1978, there have been several additions of vaccines and improvements in the schedule. In 2010, the Indian Government introduced a second dose of Measles-containing vaccine, with additional catch-up campaigns targeting children aged 9 months to 10 years in 14 states where MCV1 coverage was less than 80%. To improve the immunization coverage more than 90%, Mission Indradhanush was launched in 2014. Although full immunisation coverage of children 12-23 months was 76.6% as per the National Family Health Survey (NFHS), coverage for the second dose of the measles-containing vaccine in children 24-35 months was only 31.9%.[i] After successfully eliminating Polio, India now targets eliminating Measles. India is striving hard to improve vaccination coverage; however, achieving equitable access and ensuring sustained protection against vaccine-preventable diseases (VPDs) remains a critical challenge, particularly among marginalised rural populations. Along with vaccination coverage, development of adequate immunity in response to the vaccination is also essential for good vaccine effectiveness. Ideally, an effective vaccination programme should increase the number of individuals with positive serological immunity, reaching or exceeding the herd immunity threshold. Since vaccination programs alter the immunity of both vaccinated and unvaccinated populations, sero-epidemiology is crucial for assessing their effects.Data from these surveys can be used to gauge the country’s immunisation programme’s effectiveness and identify susceptible groups for intervention. Seroprevalence of various vaccine-preventable diseases is essential. Thus this study is planned to address the critical knowledge gap regarding the trend of persistence of vaccine-induced immunity against key childhood diseases (diphtheria, tetanus, pertussis, H. influenzae type b (Hib), hepatitis B, measles and rubella) and to assess the seroprevalence of respiratory syncytial virus (RSV) antibodies in rural population.
|