None listed
Conditions
Interventions
Intervention1: 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
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety 1A) Local adverse events 1B) Systemic adverse events 1C) Evaluation of pain 2) Efficacy 2A) Evaluation of immunogenicity to each antigen Timepoint: 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
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Joseph L Mathew
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh
Outcome results
None listed