Healthy Children After VaccinationNCT01207583
Prevenar (PCV-7) Post-Licensure Safety Study In Russia
An observational study of Healthy Children After Vaccination, run by Pfizer at 4 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children After Vaccination
- What is being tested?
- Non-interventional observational study
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 4 sitesRussia
- Study dates
- Dec 2009to Aug 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants and Children from 3 months to 23 months at enrollment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Russian State Medical University
Moscow, 119049
Russian Academy of Medical Sciences
Moscow, 119296
Research Institute of Childhood Infections
Saint Petersburg, 197022
City Children's Clinical Hospital #8
Yekaterinburg, 620085
About this study
Official title: Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
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 degrees C; > 39 to < 40 degrees C and > 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.
- Conditions
- Healthy Children After Vaccination
- Being tested
- Non-interventional observational study
- Keywords
- vaccine, infant, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional observational studyOther
Non-interventional observational study
| Study group | Role | What they receive |
|---|---|---|
| healthy children after vaccination | healthy children after vaccination Receives: Other: Non-interventional observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Febrile Reactions Post-dose 1
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
Measured: Day 1 to Day 3 post-dose 1
Percentage of Participants With Febrile Reactions Post-dose 2
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Measured: Day 1 to Day 3 post-dose 2
Percentage of Participants With Febrile Reactions Post-dose 3
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Measured: Day 1 to Day 3 post-dose 3
Percentage of Participants With Febrile Reactions Post-dose 4
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
Measured: Day 1 to Day 3 post-dose 4
Secondary outcomes (8)
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Measured: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Measured: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Measured: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Measured: Day 1 to Day 3 post-dose 4
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Day 1 to Day 3 post-dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Children After VaccinationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207583
- Sponsor's protocol ID
- 0887X1-4596
- Other IDs
- B1841011
- Status last verified
- Jul 2012
- First submitted
- 21 Sep 2010
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
- ClinicalTrials.gov ID
- NCT01207583
- Acronym / sponsor ID
- 0887X1-4596
- Conditions
- Healthy Children After Vaccination
- Keywords
- vaccine, infant, healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 degrees C; > 39 to < 40 degrees C and > 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy children after vaccination | – | Other: Non-interventional observational studyhealthy children after vaccination |
Who may qualify
- Ages
- 3 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants and Children from 3 months to 23 months at enrollment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional observational studyNon-interventional observational study | Other | healthy children after vaccination |
Primary outcome
Percentage of Participants With Febrile Reactions Post-dose 1
Time frame: Day 1 to Day 3 post-dose 1
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
Percentage of Participants With Febrile Reactions Post-dose 2
Time frame: Day 1 to Day 3 post-dose 2
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Percentage of Participants With Febrile Reactions Post-dose 3
Time frame: Day 1 to Day 3 post-dose 3
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Percentage of Participants With Febrile Reactions Post-dose 4
Time frame: Day 1 to Day 3 post-dose 4
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
8 secondary outcomes
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Time frame: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Time frame: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Time frame: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Time frame: Day 1 to Day 3 post-dose 4
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Time frame: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Time frame: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Time frame: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Time frame: Day 1 to Day 3 post-dose 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy Children After Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children After Vaccination, run by Pfizer at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Febrile Reactions Post-dose 1 (time frame: Day 1 to Day 3 post-dose 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.