InfantsNCT02119104
Prevenar (13v) Infant Drug Use Investigation
An observational study of Infants, run by Pfizer.
Trial summary
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- Infants
- What is being tested?
- Prevenar (13v)
- How many people
- 1,087 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2016
- 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 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation.
Who may be able to join
- Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
- Infants aged 2 months, inclusive, to 7 months, exclusive
- Infants with no history of administration of pneumococcal vaccines including Prevenar 13
- Infants expected to receive 4 vaccinations
Who cannot join
- Vaccines must not be performed if the vaccinee corresponds to any of the following:
- Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
- Persons with evident pyrexia
- Persons who evidently have serious acute diseases
- Besides the persons listed above, persons who are in a status inappropriate for immunization
About this study
Official title: Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
Read the detailed description
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
- Conditions
- Infants
- Being tested
- Prevenar (13v)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar (13v)Drug
Prevenar (13v)
| Study group | Role | What they receive |
|---|---|---|
| Prevenar (13v) | Not described Receives: Drug: Prevenar (13v) |
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 (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Measured: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
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 InfantsStudies 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
- 1,087 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
- NCT02119104
- Sponsor's protocol ID
- B1851122
- Status last verified
- Mar 2017
- First submitted
- 5 Mar 2014
- Last updated
- 19 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- ClinicalTrials.gov ID
- NCT02119104
- Acronym / sponsor ID
- B1851122
- Conditions
- Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,087 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.
Detailed description
The investigation will be conducted using the continuous investigation method, with which a satisfying registration conditions will be continuously registered until the number of contracted cases is reached.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevenar (13v) | – | Drug: Prevenar (13v) |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation.
Key inclusion criteria (4 listed)
- Vaccinees who meet all of the following conditions at the time of the first vaccination among infants who use Prevenar 13 in accordance with the indication, and dosage and administration of the vaccine will be included in the investigation:
- Infants aged 2 months, inclusive, to 7 months, exclusive
- Infants with no history of administration of pneumococcal vaccines including Prevenar 13
- Infants expected to receive 4 vaccinations
Key exclusion criteria (5 listed)
- Vaccines must not be performed if the vaccinee corresponds to any of the following:
- Persons in whom a past history of anaphylaxis due to an ingredient of Prevenar 13 or diphtheria toxoid is evident
- Persons with evident pyrexia
- Persons who evidently have serious acute diseases
- Besides the persons listed above, persons who are in a status inappropriate for immunization
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 |
|---|---|---|
| Prevenar (13v)Prevenar (13v) | Drug | Prevenar (13v) |
Primary outcome
Number of Participants With Adverse Reactions
Time frame: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Infants, run by Pfizer.
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 4 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 19 Jun 2017). 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: The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.). 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 19 Jun 2017.