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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521897
First received: September 14, 2011
Last updated: December 14, 2015
Last verified: December 2015

September 14, 2011
December 14, 2015
September 2010
January 2013   (final data collection date for primary outcome measure)
Number of Participants With Adverse Reactions [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
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.).
  • The actual status of the usage of Prevenar in routine utilization. ・Vaccination record of Prevenar (month of age at each vaccination time, vaccination sites) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The actual status of the usage of Prevenar in routine utilization. ・The presence or absence of the other concomitant vaccines with Prevenar (name and vaccination sites of other concomitant vaccines) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01521897 on ClinicalTrials.gov Archive Site
  • Number of Participants With Serious Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Injection Site Reactions [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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".
  • Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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).
  • Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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).
  • The occurrence of local reactions at the injection site [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Systemic reactions for each concomitant vaccine (especially fever more than 39C°) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Number of Participants by Month of Age at Each Vaccination Time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of participants was counted by month of age at each vaccination time (first to fourth).
  • Number of Participants by Vaccination Sites at Each Vaccination Time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of participants was counted by vaccination sites at each vaccination time (first to fourth).
  • Number of Participants by Pattern of Concomitant Vaccines [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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).
  • Number of Participants by Pattern of Concomitant Vaccination Sites [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.
Not Provided
 
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
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:

  1. Local reactions at the injection site
  2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
  • Pneumococcal Vaccine
  • Streptococcus Pneumoniae
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
7-valent vaccine injection
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Intervention: Biological: 7-valent vaccine injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1143
April 2015
January 2013   (final data collection date for primary outcome measure)

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
Both
2 Months to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01521897
0887X1-4447, B1841005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP