None listed
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
IntegriMedical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy participants aged between 6 weeks to less than equal to 2 years of age at the time of inclusion who are eligible to receive the respective vaccine as per the local IAP recommendations 2. Participants with good general health, as determined by the medical history, physical examination, and clinical judgment of the investigator 3. Parents or legal guardian or any other LAR willing to participate and provide informed consent 4. Participants for whom the investigator believes that their parents or LARs can and will comply with the requirements of the protocol
Exclusion criteria
Exclusion criteria: 1. Participants who are not eligible to receive the respective vaccine due to contraindications to any component of the vaccine as per its locally approved label 2. A history of previous anaphylactic or other severe vaccineassociated adverse events 3. A known or suspected impairment of the immune system including HIV infection, or recipient of immunosuppressive agents 4. A major congenital, developmental, or serious chronic disorder 5. A confirmed or suspected underlying evolving neurological disorder or history of seizures 6. A history of thrombocytopenia or any coagulation disorder. 7. Any acute illness at the time of vaccine administration 8. Participation in another clinical trial during the present trial period or in 2 weeks preceding the trial inclusion. 9. In an emergency setting or when hospitalized involuntarily
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants reporting any local reaction at the injection site in both groups at 2 minutes, 15 minutes, 30 minutes, 24 hours, 48 hours, and 7 days post-vaccination 1. Pain 2. Erythema 3. Swelling 4. Tenderness 5. Oozing of bloodTimepoint: 2 minutes, 15 minutes, 30 minutes, 24 hours, 48 hours, and 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants reporting local reactions at the injection site stratified by age and vaccination type 2. Proportion of participants with local injection site reactions at 2 minutes, 15 minutes, 30 minutes, 24 hours, 48 hours, and 7 days post-vaccination in both groups Pain severity based on the cumulative scores Erythema graded as Mild - less than equal to 10 mm, Moderate - 10 to 30 mm, or Severe greater than equal to 30 mm Swelling graded as Mild - less than 10 mm, Moderate 10 to 30 mm, or Severe greater than 30 mm Tenderness as No reaction to touch, Minor reaction on touch, Cries or protests on touch, and Cries when the limb is moved or spontaneously painful 3. Proportion of participants reporting any other solicited and unsolicited events related to vaccine in both groups, such asfever, nausea or vomiting, diarrhea, headache, fatigue, and myalgia from baseline to Day 7 in both groupsTimepoint: 2 minutes, 15 minutes, 30 minutes, 24 hours, 48 hours, and 7 days | — |
Countries
India
Contacts
Public ContactDr Ashish Agrawal
IntegriMedical Private Limited
Outcome results
None listed