Pneumococcal VaccineNCT01521897
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
An observational study of Pneumococcal Vaccine and Streptococcus Pneumoniae, run by Pfizer at 1 site in Japan.
Trial summary
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Pneumococcal Vaccine, Streptococcus Pneumoniae
- What is being tested?
- 7-valent vaccine injection
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,143 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Apr 2015
- 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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Who may be able to join
- Infants at the age of more than 2 and less than 7 months
- Infants who have been vaccinated with Prevenar for the first time
- Infants expected to complete four vaccinations with Prevenar
Who cannot join
- Vaccination with Prevenar must not be given to any of the following;
- History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
- Evident pyrexia
- Evident serious acute disease
- Any other infants or children ineligible for vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.
This surveillance will specifically focus on the occurrence of the following:
- Local reactions at the injection site
- Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
Read the detailed description
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.
- Conditions
- Pneumococcal Vaccine, Streptococcus Pneumoniae
- Being tested
- 7-valent vaccine injection
- Keywords
- Pneumococcal Vaccine, Prevenar, 7-valent, Special Use-result surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent vaccine injectionBiological
Also called Prevenar, 7vPnC
For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.
| Study group | Role | What they receive |
|---|---|---|
| 7-valent vaccine injection | Infants starting to receive Prevenar at the age of more than 2 and less than 7 months Receives: Biological: 7-valent vaccine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Reactions
An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
Measured: 28 days
Secondary outcomes (4)
Number of Participants With Serious Adverse Events
A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 28 days
Number of Participants With Injection Site Reactions
Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for "injection site erythema"; induration for "injection site erythema" and "injection site swelling"; tenderness for "injection site pain"; and warmth for "injection site warmth".
Measured: 28 days
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Measured: 28 days
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionApr 2015
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 Pneumococcal VaccineStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,143 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
- NCT01521897
- Sponsor's protocol ID
- 0887X1-4447
- Other IDs
- B1841005
- Status last verified
- Dec 2015
- First submitted
- 14 Sep 2011
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
- ClinicalTrials.gov ID
- NCT01521897
- Acronym / sponsor ID
- 0887X1-4447
- Conditions
- Pneumococcal Vaccine, Streptococcus Pneumoniae
- Keywords
- Pneumococcal Vaccine, Prevenar, 7-valent, Special Use-result surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,143 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.
This surveillance will specifically focus on the occurrence of the following:
- Local reactions at the injection site
- Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
Detailed description
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7-valent vaccine injection | – | Biological: 7-valent vaccine injectionInfants starting to receive Prevenar at the age of more than 2 and less than 7 months |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Key inclusion criteria (3 listed)
- Infants at the age of more than 2 and less than 7 months
- Infants who have been vaccinated with Prevenar for the first time
- Infants expected to complete four vaccinations with Prevenar
Key exclusion criteria (5 listed)
- Vaccination with Prevenar must not be given to any of the following;
- History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
- Evident pyrexia
- Evident serious acute disease
- Any other infants or children ineligible for vaccination
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 |
|---|---|---|
| 7-valent vaccine injectionAlso: Prevenar, 7vPnCFor primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose. | Biological | 7-valent vaccine injection |
Primary outcome
Number of Participants With Adverse Reactions
Time frame: 28 days
An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
4 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: 28 days
Number of Participants With Injection Site Reactions
Time frame: 28 days
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Time frame: 28 days
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Vaccine and Streptococcus Pneumoniae, run by Pfizer at 1 site in Japan.
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 5 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 20 Jan 2016). 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?
Number of Participants With Adverse Reactions (time frame: 28 days). 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 20 Jan 2016.