None listed
Conditions
Interventions
Intervention1: 13-valent Pneumococcal Conjugate Vaccine with 2-PE in Multidose vials (MDVs) and 13-valent Pneumococcal Conjugate Vaccine without 2-PE in Pre-filled Syringes (PFSs): 13vPnC contains sac
Sponsors
Pfizer Limited Subsidiary of Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)or legal guardian(s) has or have been informed of all pertinent aspects of the study. 2. Parent(s) or legal guardian(s) or caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures. 3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0) 4.Available for the entire study period and whose parent(s) or legal guardian(s) or caregiver(s) can be reached by telephone. 5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 6. Weight of 3.0 kg or greater at the time of vaccination.
Exclusion criteria
Exclusion criteria: 1. Infant who is a direct descendant (child, grandchild) of • Investigator site staff members directly involved in the conduct of the study, or • Site staff members otherwise supervised by the investigator, or • Pfizer employees directly involved in the conduct of the study. 2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and or during study participation. Participation in purely observational studies is acceptable. 3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine. 4. A previous anaphylactic reaction to any vaccine or vaccine-related component. 5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection. 7. Major known congenital malformation or serious chronic disorder. 8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erbâ??s palsy. 9. Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis). Inclusion and exclusion criteria for participant selection, including age and sex. Age and sex to be mentioned in specific boxes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the safety profile of 13vPnC with 2-PE in the MDV group and without 2-PE in the PFS group Primary Endpoint: 1. Incidence of local reactions and systemic events, Adverse events, serious adverse events and Incidence of newly diagnosed chronic medical conditions at defined time periods in the MDV group and in the PFS groupTimepoint: From 6 week visit to 1 month after the infant series (13 Month visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the pneumococcal immune responses induced by 13vPnC with 2-PE in the MDV group and in the PFS group Timepoint: 18 week visit and 13 month visit | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer India
Outcome results
None listed