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- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Prevenar (13v) Infant Drug Use Investigation | |||
| Official Title | Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan) | |||
| Brief 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. | |||
| 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 Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| 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. | |||
| Condition | Infants | |||
| Intervention | Drug: Prevenar (13v)
Prevenar (13v) | |||
| Study Groups/Cohorts | Prevenar (13v)
Intervention: Drug: Prevenar (13v) | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 1087 | |||
| Original Estimated Enrollment | 1000 | |||
| Actual Study Completion Date | May 2016 | |||
| Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 2 Months to 6 Months (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT02119104 | |||
| Other Study ID Numbers | B1851122 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||