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Prevenar (13v) Infant Drug Use Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119104
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Infants Drug: Prevenar (13v)

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.

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Study Type : Observational
Actual Enrollment : 1087 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevenar (13v) Infant Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prevenar (13v) Drug: Prevenar (13v)
Prevenar (13v)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119104


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02119104    
Other Study ID Numbers: B1851122
First Posted: April 21, 2014    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs