Healthy Thai infants aged 2 months. Healthy, Infant
Conditions
Interventions
Three doses of Pneumococcal Conjugate Vaccine.
Administration as Intramuscular (IM) injection at two, four, and nine months of age.,Two doses of Pneumococcal Conjugate Vaccine
Administration as Intram
2+1 schedule (2, 4, 9 month),1+1 schedule (2, 6 month),1+1 schedule (2, 9 month)
Sponsors
The National Vaccine Institute (NVI), Thailand
Eligibility
Sex/Gender
All
Age
2 Months to 2 Months
Inclusion criteria
Inclusion criteria: 1) Female or male infants aged 2 months (plus/minus 7 days). 2) Participants with normal birthweight. 3) Participants born to HIV-uninfected mothers. 4) Participants that have parent or legal caregiver capable of comprehending Thai (speaking, reading, writing) and abiding by protocol instructions. 5) Participants that have parent or legal caregiver that are available throughout the trial period. 6) Participants that have parent or legal caregiver willing to provide written inform consent to have their children participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Participants with severe illnesses, unmanageable symptoms, or underlying unstable disease. 2) Participants with a history of pneumococcal disease (microbiologically confirmed). 3) Participants with a history of severe drug or vaccine allergies (anaphylaxis), especially PCV or vaccines that contain diphtheria toxoid. 4) Participants with Streptococcus pneumoniae vaccination history. 5) Participants that received any vaccines within 14 days of screening and enrollment. 6) Participants that received plasma, immunoglobulins, antivirals, antibodies, or blood transfusions, products, or components within 90 days prior to screening and enrollment. 7) Participants with a fever (greater than 37.2 degree celsius under the arm) at screening or baseline. 8) Participants with a history of immunodeficiencies or immunocompromise since, or soon after, birth. 9) Participants with severe cardiovascular, digestive, pulmonary, endocrine, or central nerve system illness since, or soon after, birth. 10) Participants with other clinically significant reason, as determined by the investigator, that may affect immune responses to PCV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumococcal serotype-specific carriage Month 7, 18 Nasopharyngeal swab | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity Month 7, 10, 18 IgG | — |
Countries
Thailand
Contacts
Public ContactWanatpreeya Phongsamart
Siriraj Hospital Mahidol University
Outcome results
None listed