Phase 3
N=355
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00452452 ↗Enrolled (actual)
355
Serious AEs
2.5%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination — 100.0; 100.0; 99.3; 98.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination |
100.0; 100.0; 99.3; 98.8; 100.0; 99.3 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups |
3.63; 4.28; 3.37; 4.77; 3.38; 3.41 | — |
| SECONDARY Percentage of Participants Reporting Pre-Specified Local Reactions |
15.1; 33.3; 42.3; 15.1; 43.7; 15.2 | — |
| SECONDARY Percentage of Participants Reporting Pre-Specified Systemic Events |
3.4; 3.7; 0.7; 8.1; 5.1; 5.1 | — |
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
Eligibility Criteria
Inclusion Criteria
- Aged from 7 months to <72 months at time of enrollment.
- Available for entire study period and whose parent/legal guardian could be reached by telephone.
- Healthy as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae.
- Major known congenital malformation or serious chronic disorders.
- 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 Erb palsy.
- Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
- Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- Child is a direct descendant (child or grandchild) of a member of the study site personnel.
Data sourced from ClinicalTrials.gov (NCT00452452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.