N/A
N=100
Prevenar (PCV-7) Post-Licensure Safety Study In Russia
Healthy Children After Vaccination
Bottom Line
View on ClinicalTrials.gov: NCT01207583 ↗Enrolled (actual)
100
Serious AEs
0.8%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants With Febrile Reactions Post-dose 1 — 14.3; 16.1; 1.8; 0.0 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-interventional observational study (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Febrile Reactions Post-dose 1 |
14.3; 16.1; 1.8; 0.0; 3.2; 3.6 | — |
| PRIMARY Percentage of Participants With Febrile Reactions Post-dose 2 |
23.1; 10.3; 0.0 | — |
| PRIMARY Percentage of Participants With Febrile Reactions Post-dose 3 |
15.4; 0.0 | — |
| PRIMARY Percentage of Participants With Febrile Reactions Post-dose 4 |
0.0 | — |
| SECONDARY Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 |
7.1; 19.4; 27.3; 0.0; 6.5; 25.5 | — |
| SECONDARY Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 |
23.1; 13.8; 20.4; 0.0; 0.0; 11.1 | — |
| SECONDARY Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 |
15.4; 3.8; 7.7; 3.8; 7.7; 7.7 | — |
| SECONDARY Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 |
14.3; 14.3; 14.3 | — |
| SECONDARY Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 |
7.1; 19.4; 23.6; 7.1; 3.2; 9.1 | — |
| SECONDARY Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 |
15.4; 10.3; 9.3; 15.4; 3.4; 0.0 | — |
| SECONDARY Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 |
7.7; 0.0; 15.4; 3.8; 15.4; 0.0 | — |
| SECONDARY Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 |
28.6; 14.3; 14.3 | — |
Summary
This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.
The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to 39 to 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
Eligibility Criteria
Inclusion Criteria
- Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
- Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
- Parents or legal guardians willing and able to complete the diary cards.
Exclusion Criteria
- Hypersensitivity to the active substances or to any of the excipients;
- Hypersensitivity to diphtheria toxoid;
- Age less than 3 months or greater than or equal to 2 years at enrollment;
- Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
- Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
- Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
Data sourced from ClinicalTrials.gov (NCT01207583). 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.