| CTRI Number |
CTRI/2026/01/102496 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Safety and efficacy of microneedles for human immunization (SEMHI) study. |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of intradermal administration of vaccines using indigenous microneedles: A pre-clinical study in mice, followed by clinical study in human beings. |
| 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 Joseph L Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER)Chandigarh |
| Address |
Department of Pediatrics,
Advanced Pediatrics Centre,
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755357 |
| Fax |
|
| Email |
dr.joseph.l.mathew@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseph L Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh |
| Address |
Department of Pediatrics,
Advanced Pediatrics Centre,
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755357 |
| Fax |
|
| Email |
dr.joseph.l.mathew@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joseph L Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh |
| Address |
Department of Pediatrics,
Advanced Pediatrics Centre,
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755357 |
| Fax |
|
| Email |
dr.joseph.l.mathew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR).
ICMR JHeadquarters
Ansari Nagar
New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Indian Council of Medical Research (ICMR)
Address: Indian Council of Medical Research (ICMR), Ansari Nagar, New Delhi 110029
|
| Type of Sponsor |
Government funding agency |
|
|
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 Joseph L Mathew |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh |
Research Room 5424,
Advanced Pediatrics Centre,
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh
Chandigarh
CHANDIGARH |
01722755357
DR.JOSEPH.L.MATHEW@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vaccine delivered through conventional hypodermic needles. |
Age appropriate vaccine will be used.
(1) Healthy adult volunteers (age 18-50 years old): TT vaccine
(2) Healthy adolescent volunteers (10-17.9 years old): TT vaccine
(3) Healthy children (5-6 years old) eligible for DPT vaccine booster dose: DPT booster dose
(4) Healthy infants (18-24 months old) eligible for DPT vaccine booster dose: Pentavalent vaccine booster dose
(5) Healthy young infants (14-18 weeks old) eligible for third dose of Pentavalent vaccine
|
| Intervention |
Vaccine delivered through microneedles |
Age appropriate vaccine will be used.
(1) Healthy adult volunteers (age 18-50 years old): TT vaccine
(2) Healthy adolescent volunteers (10-17.9 years old): TT vaccine
(3) Healthy children (5-6 years old) eligible for DPT vaccine booster dose: DPT booster dose
(4) Healthy infants (18-24 months old) eligible for DPT vaccine booster dose: Pentavalent vaccine booster dose
(5) Healthy young infants (14-18 weeks old) eligible for third dose of Pentavalent vaccine
|
|
|
Inclusion Criteria
|
| Age From |
3.50 Month(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult volunteers (age 18-50 years old)
Healthy adolescent volunteers (10-17.9 years old)
Healthy children (5-6 years old) eligible for DPT vaccine booster dose
Healthy infants (18-24 months old) eligible for DPT vaccine booster dose
Healthy young infants (14-18 weeks old) eligible for third dose of Pentavalent vaccine
|
|
| ExclusionCriteria |
| Details |
1. Age group:18-50 years old (adults)
• Current pregnancy
• Current lactation
• Known immune-deficiency state
• Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications
• Recent or anticipated surgery (within 6 months)
• Previous history of tetanus
2. Age group:10-17.9 years old (adolescents)
• Known immune-deficiency state
• Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications.
• Recent or anticipated surgery (within 6 months)
• Previous history of tetanus
3. Age group: 5-6 years old (children)
• Known immune-deficiency state
• Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications
• Recent or anticipated surgery (within 6 months)
• Previous history of diphtheria or pertussis or tetanus
4. Age group:18-24 months old (old infants)
• Known immune-deficiency state
• Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications
• Recent or anticipated surgery (within 6 months)
• Previous history of diphtheria or pertussis or tetanus
• Development delay
• Any past or present neurological illness
• Feeding difficulty
• Any illness involving the cardio-respiratory system
5. Age group:14-18 weeks old (young infants)
• Known immune-deficiency state
• Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications
• Recent or anticipated surgery (within 6 months)
• Previous history of diphtheria or pertussis or tetanus or Hepatitis B or Hib disease
• Development delay
• Any past or present neurological illness
• Feeding difficulty
• Any illness involving the cardio-respiratory system
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Safety
1A) Local adverse events
1B) Systemic adverse events
1C) Evaluation of pain
2) Efficacy
2A) Evaluation of immunogenicity to each antigen
|
1) Safety
1A) Local adverse events
1B) Systemic adverse events
1C) Evaluation of pain
Timepoints: Baseline, 30 mins, 60 mins, 72 hours, 7 days
2) Efficacy
2A) Evaluation of immunogenicity to each antigen
Timepoints: baseline, 7 days, 28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
10/02/2026 |
| 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="2"
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
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [DR.JOSEPH.L.MATHEW@GMAIL.COM].
- For how long will this data be available start date provided 01-02-2028 and end date provided 31-01-2031?
Response (Others) - THREE YEARS AFTER COMPLETION OF THE TRIAL.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
This trial aims to compare the safety and immunogenicity of intradermal administration of vaccines using microneedles, in comparison to conventional intramuscular injection, and intradermal administration using hypodermic needles, in human subjects in an age-de-escalating manner, i.e. adults, followed by adolescents, followed by school-age children, followed by older infants, followed by young infants. Extensive animal experiments in three mammalian models (mice, guinea pig and rats) have confirmed pre-clinical safety and efficacy. |