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
  Purpose

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 Intervention
Pneumococcal Vaccine
Streptococcus Pneumoniae
Biological: 7-valent vaccine injection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.).


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Enrollment: 1143
Study Start Date: September 2010
Study Completion Date: April 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   2 Months to 2 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521897     History of Changes
Other Study ID Numbers: 0887X1-4447  B1841005 
Study First Received: September 14, 2011
Results First Received: December 14, 2015
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2016