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Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01521897
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

This surveillance will specifically focus on the occurrence of the following:

  1. Local reactions at the injection site
  2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Condition or disease Intervention/treatment
Pneumococcal Vaccine Streptococcus Pneumoniae Biological: 7-valent vaccine injection

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 Type : Observational
Actual Enrollment : 1143 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
Study Start Date : September 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
7-valent vaccine injection
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Biological: 7-valent vaccine injection
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.
Other Name: Prevenar, 7vPnC



Primary Outcome Measures :
  1. 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.).


Secondary Outcome Measures :
  1. Number of Participants With Serious Adverse Events [ Time Frame: 28 days ]
    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.

  2. Number of Participants With Injection Site Reactions [ Time Frame: 28 days ]
    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".

  3. Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination [ Time Frame: 28 days ]
    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).

  4. Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination [ Time Frame: 28 days ]
    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).


Other Outcome Measures:
  1. Number of Participants by Month of Age at Each Vaccination Time [ Time Frame: 28 days ]
    Number of participants was counted by month of age at each vaccination time (first to fourth).

  2. Number of Participants by Vaccination Sites at Each Vaccination Time [ Time Frame: 28 days ]
    Number of participants was counted by vaccination sites at each vaccination time (first to fourth).

  3. Number of Participants by Pattern of Concomitant Vaccines [ Time Frame: 28 days ]
    Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used 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).

  4. Number of Participants by Pattern of Concomitant Vaccination Sites [ Time Frame: 28 days ]
    Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.



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Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT01521897


Locations
Japan
Yokoyama Children's Clinic
Kasuga, Fukuoka, Japan, 816-0801
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521897     History of Changes
Other Study ID Numbers: 0887X1-4447
B1841005 ( Other Identifier: Alias Study Number )
First Posted: January 31, 2012    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016
Last Verified: December 2015

Keywords provided by Pfizer:
Pneumococcal Vaccine
Prevenar
7-valent
Special Use-result surveillance

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs